Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051, 9354-9362 [2019-04710]

Download as PDF 9354 Federal Register / Vol. 84, No. 50 / Thursday, March 14, 2019 / Notices those interested in participating in this voluntary program. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Section of the FD&C act; activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours 704(g); Request for Accreditation ........................................ 1 1 1 80 80 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. Dated: March 8, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–04717 Filed 3–13–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2004–N–0451] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 051’’ (Recognition List Number: 051), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit either electronic or written comments on the notice at any time. These modifications to the list of recognized standards are applicable March 14, 2019. ADDRESSES: You may submit comments on the current list of FDA Recognized Consensus Standards at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: VerDate Sep<11>2014 17:22 Mar 13, 2019 Jkt 247001 • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2004–N–0451 for ‘‘Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 a.m. and 4 p.m., Monday through Friday. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 051. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. An electronic copy of Recognition List Number: 051 is available on the internet E:\FR\FM\14MRN1.SGM 14MRN1 9355 Federal Register / Vol. 84, No. 50 / Thursday, March 14, 2019 / Notices at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ Standards/ucm123792.htm. See section IV for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 051 modifications and other standards related information. Submit written requests for a single hard copy of the document entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 051’’ to Scott Colburn (see FOR FURTHER INFORMATION CONTACT). Send one self-addressed adhesive label to assist that office in processing your request or Fax your request to 301–847–8144. FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301–796–6287, CDRHStandardsStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105–115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements. In the Federal Register of September 14, 2018 (83 FR 46738), FDA announced the availability of a guidance entitled ‘‘Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.’’ The guidance describes how FDA has implemented its standard recognition program and is available at https:// www.fda.gov/downloads/ MedicalDevices/DeviceRegulation andGuidance/GuidanceDocuments/ ucm077295.pdf. Modifications to the initial list of recognized standards, as published in the Federal Register, can be accessed at https://www.fda.gov/ MedicalDevices/DeviceRegulation andGuidance/Standards/ ucm123792.htm. These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains hypertext markup language (HTML) and portable document format (PDF) versions of the list of FDA Recognized Consensus Standards. Additional information on the Agency’s standards program is available at https://www.fda.gov/ MedicalDevices/DeviceRegulation andGuidance/Standards/default.htm. II. Modifications to the List of Recognized Standards, Recognition List Number: 051 FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency is recognizing for use in premarket submissions and other requirements for devices. FDA is incorporating these modifications to the list of FDA Recognized Consensus Standards in the Agency’s searchable database. FDA is using the term ‘‘Recognition List Number: 051’’ to identify the current modifications. In table 1, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, if applicable; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards. In section III, FDA lists modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA. TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS Old recognition No. Replacement recognition No. Title of standard 1 Change 2 A. Anesthesiology 1–104 ........... 1–141 1–108 ........... ........................ 1–110 ........... ........................ 1–111 ........... ........................ 1–114 ........... ........................ 1–117 ........... ........................ 1–118 ........... ........................ 1–120 ........... ........................ 1–138 ........... ........................ ISO 80601–2–13 First edition 2011–08–11 Medical electrical equipment—Part 2– 13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: AMENDMENT 1 (2015) and AMENDMENT 2 (2018)]. ANSI/AAMI/ISO 5361:2012 Anaesthetic and respiratory equipment—Tracheal tubes and connectors. ANSI/AAMI/ISO 5366–1:2000 Anaesthetic and respiratory equipment—Tracheostomy tubes—Part 1: Tubes and connectors for use in adults. ANSI/AAMI/ISO 5366–3:2001 Anaesthetic and respiratory equipment—Tracheostomy Tubes—Part 3: Paediatric Tracheostomy Tubes. ISO 18835 First Edition 2015–04–01 Inhalational Anaesthesia Systems—Drawover Anaesthetic Systems. ISO 5366 First edition 2016–10–01 Anaesthetic and respiratory equipment—Tracheostomy tubes and connectors. ISO 5361 Third edition 2016–09–01 Anaesthetic and respiratory equipment—Tracheal tubes and connectors. ISO 18190 First edition 2016–11–01 Anaesthetic and respiratory equipment— General requirements for airways and related equipment. ISO 80601–2–74 First edition 2017–05 Medical electrical equipment—Part 2–74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment. Withdrawn and replaced with newer version including amendment. Extent of Recognition. Withdrawn. See 1–118. Withdrawn. See 1–117. Withdrawn. See 1–117. Extent of Recognition. Extent of Recognition. Extent of Recognition. Extent of Recognition. Extent of Recognition. B. Biocompatibility 2–136 ........... ........................ 2–141 ........... ........................ VerDate Sep<11>2014 17:22 Mar 13, 2019 ASTM E1262–88 (Reapproved 2018) Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay. ASTM F1984–99 (Reapproved 2018) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials. Jkt 247001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM 14MRN1 Reaffirmation. Reaffirmation. 9356 Federal Register / Vol. 84, No. 50 / Thursday, March 14, 2019 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 2–145 ........... ........................ 2–220 ........... 2–258 2–251 ........... 2–259 ASTM F1439–03 (Reapproved 2018) Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials. ISO 10993–1 Fifth edition 2018–08 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process. USP 41–NF36:2018 <87> Biological Reactivity Test, In Vitro—Direct Contact Test 2–252 ........... 2–260 USP 41–NF36:2018 <87> Biological Reactivity Test, In Vitro—Elution Test ........... 2–253 ........... 2–261 USP 41–NF36:2018 <88> Biological Reactivity Test, In Vivo .................................. 2–254 ........... 2–262 USP 41–NF36:2018 <151> Pyrogen Test (USP Rabbit Test) ................................. Title of standard 1 Change 2 Reaffirmation. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Extent of Recognition. C. Cardiovascular 3–44 ............. 3–52 ............. 3–55 ............. ........................ ........................ ........................ 3–56 ............. ........................ 3–66 ............. ........................ 3–79 ............. ........................ 3–86 ............. ........................ 3–99 ............. ........................ 3–122 ........... ........................ 3–123 ........... ........................ 3–124 ........... ........................ 3–126 ........... ........................ 3–127 ........... ........................ 3–138 ........... ........................ 3–142 ........... ........................ AAMI BP22:1994 (R2016) Blood Pressure Transducers .......................................... ANSI/AAMI EC12:2000/(R) 2015 Disposable ECG electrodes ................................ ASTM F1830–97 (Reapproved 2017) Standard Practice for Selection of Blood for in vitro Evaluation of Blood Pumps. ASTM F1841–97 (Reapproved 2017) Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps. ASTM F2081–06 (Reapproved 2017) Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents. ASTM F2079–09 (Reapproved 2017) Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents. ASTM F2394–07 (Reapproved 2017) Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System. AAMI TIR 42:2010 Evaluation of Particulates Associated with Vascular Medical Devices. IEC 81060–2 Second edition 2013–05–01 Non-invasive sphygmomanometers— Part 2: Clinical validation of automated measurement type. IEC 80601–2–30 Edition 2.0 2018–03 Medical electrical equipment—Part 2–30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. ISO 7199:2009 Cardiovascular implants and artificial organs—Blood gas exchangers (oxygenators). IEC 60601–2–27 Edition 3.0 2011–03 Medical electrical equipment—Part 2–27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment. ANSI/AAMI/IEC 60601–2–47:2012/(R) 2016 Medical electrical equipment—Part 2–47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems. ASTM F2942–13 Standard Guide for the In Vitro Axial, Bending, and Rotational Durability Test of Vascular Stents. ISO/TS 17137 First edition 2014–05–15 Cardiovascular implants and extracorporeal systems—Cardiovascular absorbable implants. Reaffirmation. Reaffirmation. Reaffirmation. Reaffirmation. Extent of Recognition. Reaffirmation. Reaffirmation. Reaffirmation. Extent of Recognition. Extent of Recognition. Extent of Recognition. Title change. Extent of recognition. Withdrawn. Extent of recognition. Reaffirmation. Extent of Recognition. Extent of Recognition. D. Dental/Ear, Nose, and Throat (ENT) 4–126 ........... 4–248 4–150 ........... 4–249 4–162 ........... ........................ 4–163 ........... ........................ 4–171 ........... ........................ 4–213 ........... 4–250 4–217 ........... ........................ 4–223 ........... 4–251 4–226 ........... 4–252 VerDate Sep<11>2014 17:22 Mar 13, 2019 ISO 10477 Third edition 2018–06 Dentistry—Polymer-based crown and veneering materials. ANSI/ADA Standard No. 19—2018 Elastomeric Impression Materials .................... ANSI S3.4–2007 (Reaffirmed 2017) American National Standard Procedure for the Computation of Loudness of Steady Sounds. ANSI S3.5–1997 (Reaffirmed 2017) American National Standard Methods for Calculation of the Speech Intelligibility Index. ANSI S3.37–1987 (Reaffirmed 2017) American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids. ISO 7494–1 Third edition 2018–06 Dentistry—Stationary dental units and dental patient chairs—Part 1: General requirements. ANSI/ASA S3.36–2012 (Reaffirmed 2018) American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements. ISO 6872 Fourth edition 2015–06–01 Dentistry—Ceramic materials [including AMENDMENT 1 2018–04]. ISO 10650 Second edition 2018–08 Dentistry—Powered polymerization activators Jkt 247001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM 14MRN1 Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Reaffirmation. Reaffirmation. Reaffirmation. Withdrawn and replaced with newer version. Reaffirmation. Withdrawn and replaced with newer version including amendment. Withdrawn and replaced with newer version. 9357 Federal Register / Vol. 84, No. 50 / Thursday, March 14, 2019 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. Title of standard 1 Change 2 E. General I (Quality Systems/Risk Management) (QS/RM) 5–39 ............. 5–120 IEC 60812 Edition 3.0 2018–08 Failure modes and effects analysis (FMEA and FMECA). 5–63 ............. 5–121 5–105 ........... ........................ ISO 80369–1 Second edition 2018–11 Small-bore connectors for liquids and gases in healthcare applications—Part 1: General requirements. ISO 16142–1 First edition 2016–03–01 Medical devices—Recognized essential principles of safety and performance of medical devices—Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on selection of standards. Withdrawn and replaced with newer version. Title change. Withdrawn and replaced with newer version. Withdrawn. F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) 19–13 ........... 19–32 19–33 19–18 ........... 19–34 IEC 62133–1 Edition 1.0 2017–02 Secondary cells and batteries containing alkaline or other non-acid electrolytes—Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications—Part 1: Nickel systems. IEC 62133–2 Edition 1.0 2017–02 Secondary cells and batteries containing alkaline or other non-acid electrolytes—Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications—Part 2: Lithium systems. IEC 61010–1 Edition 3.1 2017–01 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1: General requirements. Withdrawn and replaced with newer version. Title change. Withdrawn and replaced with newer version. G. General Hospital/General Plastic Surgery (GH/GPS) 6–239 ........... 6–410 6–338 ........... ........................ 6–383 ........... 6–411 6–391 ........... 6–412 ISO 8536–6 Third edition 2016–12–01 Infusion equipment for medical use—Part 6: Freeze drying closures for infusion bottles. ASTM D7866–14 Standard Specification for Radiation Attenuating Protective Gloves. ASTM D6499–18 Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products. USP 41–NF36:2018 Sodium Chloride Irrigation ....................................................... 6–392 ........... 6–413 USP 41–NF36:2018 Sodium Chloride Injection ........................................................ 6–393 ........... 6–414 USP 41–NF36:2018 Nonabsorbable Surgical Suture ............................................... 6–394 ........... 6–415 USP 41–NF36:2018 <881> Tensile Strength ........................................................... 6–395 ........... 6–416 USP 41–NF36:2018 <861> Sutures—Diameter ....................................................... 6–396 ........... 6–417 USP 41–NF36:2018 <871> Sutures—Needle Attachment ....................................... 6–397 ........... 6–418 USP 41–NF36:2018 Sterile Water for Irrigation ........................................................ 6–398 ........... 6–419 USP 41–NF36:2018 Heparin Lock Flush Solution .................................................... 6–399 ........... 6–420 USP 41–NF36: 2018 Absorbable Surgical Suture .................................................... Withdrawn and replaced with newer version. Extent of recognition. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. H. In Vitro Diagnostics (IVD) 7–139 ........... ........................ 7–178 ........... ........................ 7–200 ........... 7–285 7–215 ........... ........................ 7–222 ........... ........................ VerDate Sep<11>2014 17:22 Mar 13, 2019 CLSI QMS24 3rd Edition September 2016 Replaces GP27–A2 and GP29–A2. Using Proficiency Testing and Alternative Assessment to Improve Medical Laboratory Quality. CLSI M22–A3 Vol. 24 No. 19 Replaces M22–A2 Vol. 16 No. 16 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition. CLSI M48 2nd Edition Laboratory Detection and Identification of Mycobacteria ..... CLSI M44–A2 Vol. 29 No. 17 Replaces MM44–A Vol. 24 No. 15 Method for Antifungal Disk Diffusion Susceptibility Testing of Yeast; Approved Guideline— Second Edition. CLSI M24–A2 (Replaces M24–A) Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes; Approved Standards—Second Edition. Jkt 247001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM 14MRN1 Title change. Extent of recognition. Withdrawn and replaced with a newer version. Extent of recognition. Extent of recognition. 9358 Federal Register / Vol. 84, No. 50 / Thursday, March 14, 2019 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. Title of standard 1 Change 2 7–228 ........... 7–286 CLSI M11 9th Edition Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria. 7–232 ........... ........................ 7–262 ........... ........................ 7–269 ........... ........................ 7–282 ........... ........................ CLSI MM05–A2 Vol. 32 No. 6 Replaces MM05–A Vol. 23 No. 17 Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline— Second Edition. CLSI M45 3rd Edition Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria. CLSI MM23 1st Edition Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms). CLSI M60 1st Edition Performance Standards for Antifungal Susceptibility Testing of Yeasts. Withdrawn and replaced with a newer version. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Withdrawn. Duplicate version. I. Materials 8–179 ........... ........................ 8–335 ........... 8–480 8–345 ........... 8–481 8–365 ........... 8–482 8–371 ........... 8–483 8–375 ........... 8–484 8–462 ........... 8–485 ASTM F754–08 (Reapproved 2015) Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders. ASTM F2063–18 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. ASTM F1314–18 Standard Specification for Wrought Nitrogen Strengthened 22 Chromium—13 Nickel—5 Manganese—2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910). ASTM D1505–18 Standard Test Method for Density of Plastics by the DensityGradient Technique. ASTM F601–18 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants. ASTM F2066–18 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150). ASTM F3260–18 Standard Test Method for Determining the Flexural Stiffness of Medical Textiles. Extent of recognition. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. J. Nanotechnology 18–2 ............. ........................ 18–5 ............. ........................ 18–6 ............. ........................ 18–7 ............. ........................ 18–8 ............. ........................ ASTM E2535–07 (Reapproved 2018) Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings. ASTM E2859–11 (Reapproved 2017) Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy. ASTM E2865–12 (Reapproved 2018) Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological Materials. ASTM E2834–12 (Reapproved 2018) Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Nanoparticle Tracking Analysis (NTA). ASTM E2578–07 (Reapproved 2018) Standard Practice for Calculation of Mean Sizes/Diameters and Standard Deviations of Particle Size Distributions. Reaffirmation. Reaffirmation. Reaffirmation. Reaffirmation. Reaffirmation. K. Neurology 17–14 ........... ........................ ANSI/AAMI NS4:2013/(R) 2017 Transcutaneous electrical nerve stimulators ......... Reaffirmation. L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology) 9–68 ............. ........................ 9–80 ............. 9–121 9–89 ............. ........................ 9–93 ............. 9–122 9–111 ........... ........................ 9–112 ........... ........................ ISO 23409 First edition 2011–02–15 Male Condoms—Requirements and test methods for condoms made from synthetic materials. IEC 60601–2–16 Edition 5.0 2018–04 Medical electrical equipment—Part 2–16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. ANSI AAMI ISO 8638:2010 (R2015) Cardiovascular implants and extracorporeal systems—Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters. ISO 25841 Third edition 2017–08 Female condoms—Requirements and test methods. ISO 4074 Third edition 2015–10–15 Natural latex rubber condoms—Requirements and test methods. ASTM D3492–16 Standard Specification for Rubber Contraceptives (Male Condoms). Extent of Recognition. Withdrawn and replaced with newer version. Reaffirmation. Withdrawn and replaced with newer version. Extent of Recognition. Extent of Recognition. M. Ophthalmic 10–74 ........... VerDate Sep<11>2014 ........................ 17:22 Mar 13, 2019 ISO 10940 Second edition 2009–08–01 Ophthalmic instruments—Fundus cameras. Jkt 247001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM 14MRN1 Extent of recognition. 9359 Federal Register / Vol. 84, No. 50 / Thursday, March 14, 2019 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 10–85 ........... ........................ 10–86 ........... ........................ 10–89 ........... ........................ 10–93 ........... ........................ 10–108 ......... ........................ Title of standard 1 Change 2 ISO 11980 Third edition 2012–11–15 Corrected version 2012–12–01 Ophthalmic optics—Contact lenses and contact lens care products—Guidance for clinical investigations. ISO 14729 First edition 2001–04–15 Ophthalmic optics—Contact lens care products—Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [Including: Amendment 1 (2010)]. ANSI Z80.7–2013 (R2018) American National Standard for Ophthalmic Optics— Intraocular Lenses. ANSI Z80.27–2014 American National Standard for Ophthalmics—Implantable Glaucoma Devices. ISO 18369–2 Third Edition 2017–08 Ophthalmic optics—Contact lenses—Part 2: Tolerances. Title change. Extent of recognition. Extent of recognition. Reaffirmation. Extent of recognition. Extent of recognition. Extent of recognition. N. Orthopedic 11–184 ......... ........................ 11–234 ......... 11–342 11–243 ......... 11–343 11–272 ......... ........................ 11–295 ......... 11–344 11–302 ......... 11–345 11–323 ......... 11–346 11–331 ......... 11–347 ISO 8827 First edition 1988–10–15 Implants for surgery—Staples with parallel legs for orthopaedic use—General requirements. ASTM F732–17 Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses. ASTM F2346–18 Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs. ASTM F1714–96 (Reapproved 2018) Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices. ASTM F2580–18 Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis. ASTM F1717–18 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. ASTM F2706–18 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model. ASTM F2077–18 Test Methods for Intervertebral Body Fusion Devices ................. Extent of Recognition. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Reaffirmation. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. O. Physical Medicine 16–29 ........... 16–204 16–202 ......... 16–205 ISO 7176–6 Third edition 2018–06 Wheelchairs—Part 6: Determination of maximum speed of electrically powered wheelchairs. RESNA WC–4:2017 Standard for Wheelchairs Volume 4: Wheelchairs and Transportation. Withdrawn and replaced with newer version. Withdrawn and replaced with new recognition number. P. Radiology 12–102 ......... ........................ 12–179 ......... 12–321 12–231 ......... 12–322 12–247 ......... 12–323 12–305 ......... 12–324 ANSI/IES RP–27.2–00/R17 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—Measurement Techniques. ANSI/IES RP–27.3–17 Recommended Practice for Photobiological Safety for Lamps—Risk Group Classification and Labeling. NEMA MS 5–2018 Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging. ISO 11990 Third edition 2018–08 Lasers and laser-related equipment—Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs. ISO 13694 Third edition 2018–11 Optics and Photonics—Lasers and laser-related equipment—Test methods for laser beam power (energy) density distribution. Reaffirmation. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Title change. Withdrawn and replaced with newer version. Q. Software/Informatics 13–32 ........... ........................ 13–79 ........... ........................ ANSI AAMI IEC 62304:2006 Medical device software—Software life cycle processes. IEC 62304 Edition 1.1 2015–06 CONSOLIDATED VERSION Medical device software—Software life cycle processes. Transition period. Title change and transition period. R. Sterility 14–314 ......... ........................ 14–311 ......... 14–518 14–396 ......... ........................ VerDate Sep<11>2014 17:22 Mar 13, 2019 ANSI/AAMI ST67:2011/(R) 2017 Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled ‘sterile’. ANSI/AAMI ST55:2016 Table-top steam sterilizers .................................................. ANSI/AAMI ST77:2013/(R) 2018 Containment devices for reusable medical device sterilization. Jkt 247001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM 14MRN1 Reaffirmation. Withdrawn and replaced with newer version. Reaffirmation. 9360 Federal Register / Vol. 84, No. 50 / Thursday, March 14, 2019 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. Title of standard 1 Change 2 14–410 ......... 14–519 ASTM F17–18 Standard Terminology Relating to Primary Barrier Packaging ........ 14–503 ......... 14–520 14–504 ......... 14–521 USP 41–NF36:2018 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. USP 41–NF36:2018 <71> Sterility Tests .................................................................. 14–505 ......... 14–522 USP 41–NF36:2018 <85> Bacterial Endotoxins Test ............................................... 14–506 ......... 14–523 14–507 ......... 14–524 14–508 ......... 14–525 USP 41–NF36:2018 <161> Medical Devices—Bacterial Endotoxin and Pyrogen Tests. USP 41–NF36:2018 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. USP 41–NF36:2018 <55> Biological Indicators—Resistance Performance Tests .. 14–509 ......... 14–526 USP 41–NF36:2018 <1229.5> Biological Indicators for Sterilization ....................... Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. S. Tissue Engineering 15–47 ........... ........................ ISO 22442–3 First edition 2007–12–15 Medical devices utilizing animal tissues and their derivatives—Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents. Extent of Recognition. 1 All standard titles in this table conform to the style requirements of the respective organizations. that are ‘‘Withdrawn’’ or ‘‘Withdrawn and replaced with newer version’’ will have a transition period with an expiration date as noted in the recognition database https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. 2 Standards III. Listing of New Entries In table 2, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 051. TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS Title of standard 1 Recognition No. Reference No. and date A. Anesthesiology No new entries at this time.. B. Biocompatibility No new entries at this time.. C. Cardiovascular 3–157 ...................... 3–158 ...................... 3–159 ...................... Cardiovascular implants—Endovascular devices—Part 1: Endovascular prostheses. Standard Guide for Coating Characterization of Drug Coated Balloons .............. Cardiovascular implants and extracorporeal systems—Cardiac valve repair devices. ANSI/AAMI/ISO 25539–1: 2017. ASTM F3320–18. ISO 5910 First edition 2018–06. D. Dental/Ear, Nose, and Throat (ENT) 4–253 ...................... 4–254 ...................... Polymer-based Restorative Materials .................................................................... Athletic Mouth Protectors and Materials ................................................................ 4–255 ...................... 4–256 ...................... 4–257 ...................... Dental CAD/CAM Machinable Zirconia Blanks ..................................................... Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems ...... Dentistry—Fluoride varnishes ................................................................................ ANSI/ADA Standard No. 27–2016. ANSI/ADA Standard No. 99–2001 (Reaffirmed 2013). ANSI/ADA Standard No. 131–2015. ANSI/ADA Standard No. 132–2015. ISO 17730 First edition 2014–11–01. E. General I (Quality Systems/Risk Management) (QS/RM) 5–122 ...................... Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices. ASME V&V 40–2018. F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) No new entries at this time.. VerDate Sep<11>2014 17:22 Mar 13, 2019 Jkt 247001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM 14MRN1 Federal Register / Vol. 84, No. 50 / Thursday, March 14, 2019 / Notices 9361 TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued Title of standard 1 Recognition No. Reference No. and date G. General Hospital/General Plastic Surgery (GH/GPS) No new entries at this time.. H. In Vitro Diagnostics (IVD) No new entries at this time.. I. Materials 8–486 ...................... 8–487 ...................... 8–488 ...................... 8–489 ...................... 8–490 ...................... Standard Guide for in vitro Degradation Testing of Absorbable Metals ............... Additive manufacturing—Design—Requirements, guidelines and recommendations. Standard for Additive Manufacturing—Post Processing Methods—Standard Specification for Thermal Post-Processing Metal Parts Made Via Powder Bed Fusion. Standard for Additive Manufacturing—Finished Part Properties—Standard Specification for Titanium Alloys via Powder Bed Fusion. Standard for Additive Manufacturing—Process Characteristics and Performance: Practice for Metal Powder Bed Fusion Process to Meet Critical Applications. ASTM F3268–18. ISO/ASTM52910–18. ASTM F3301–18a. ASTM F3302–18. ASTM F3303–18. J. Nanotechnology 18–11 ...................... Nanotechnologies—Nanomaterial risk evaluation ................................................. 18–12 ...................... Nanotechnology—Nanoparticles in powder form—Characteristics and measurements. ISO/TR 13121 First edition 2011–05– 15. ISO/TS 17200 First edition 2013–06– 01. K. Neurology No new entries at this time.. L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology) No new entries at this time.. M. Ophthalmic 10–114 .................... 10–115 .................... American National Standard for Ophthalmics—Methods of Reporting Optical Aberrations of Eyes. American National Standard for Ophthalmics—Accommodative Intraocular Lenses. ANSI Z80.28–2017. ANSI Z80.29–2015. N. Orthopedic 11–348 .................... Implants for surgery—Cleanliness of orthopedic implants—General requirements. ISO 19227 First edition 2018–03. O. Physical Medicine 16–206 .................... Walking aids manipulated by both arms—Requirements and test methods— Part 2: Rollators. ISO 11199–2 Second edition 2005–04– 15. P. Radiology No new entries at this time.. Q. Software/Informatics 13–105 .................... 13–106 .................... 13–107 .................... Classification of defects in health software ........................................................... Health informatics—Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication. Health informatics—Point-of-care medical device communication—Part 20702: Medical devices communication profile for web services. ANSI/AAMI SW91:2018. IEEE Std 11073–10207–2017. ISO/IEEE 11073–20702 First edition 2018–09. R. Sterility No new entries at this time.. VerDate Sep<11>2014 17:22 Mar 13, 2019 Jkt 247001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM 14MRN1 9362 Federal Register / Vol. 84, No. 50 / Thursday, March 14, 2019 / Notices TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued Title of standard 1 Recognition No. Reference No. and date S. Tissue Engineering 15–56 ...................... 1 All Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging. ASTM F3224–17. standard titles in this table conform to the style requirements of the respective organizations. IV. List of Recognized Standards FDA maintains the current list of FDA Recognized Consensus Standards in a searchable database that may be accessed at https:// www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfStandards/search.cfm. Such standards are those that FDA has recognized by notice published in the Federal Register or that FDA has decided to recognize but for which recognition is pending (because a periodic notice has not yet appeared in the Federal Register). FDA will announce additional modifications and revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often if necessary. Beginning with list 52, FDA will no longer announce in the Federal Register updates to current recognized standards for reapproved or reaffirmed standards because reapproved or reaffirmed standards have not changed from the recognized standard. International and national standards developing organizations use the designations of reapproved or reaffirmed to indicate a standard has been reviewed but no changes were made to the standard at that time. V. Recommendation of Standards for Recognition by FDA Any person may recommend consensus standards as candidates for recognition under section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to CDRHStandardsStaff@fda.hhs.gov. To be considered, such recommendations should contain, at a minimum, the following information available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ Standards/ucm123739.htm. Dated: March 8, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–04710 Filed 3–13–19; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:22 Mar 13, 2019 Jkt 247001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request, Information Collection Request Title: HIV Quality Measures (HIVQM) Module, OMB No. 0906–0022—Revision Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this ICR must be received no later than May 13, 2019. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14N39, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer, at (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: HIV Quality Measures (HIVQM) Module OMB No. 0906–0022—Revision. Abstract: HRSA Ryan White HIV/ AIDS Program (RWHAP) funds and coordinates with cities, states, and local clinics/community-based organizations to deliver efficient and effective HIV care, treatment, and support to lowSUMMARY: PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 income people living with HIV (PLWH). Nearly two-thirds of clients (patients) live at or below 100 percent of the Federal poverty level and approximately three-quarters of RWHAP clients are racial/ethnic minorities. Since 1990, the RWHAP has developed a comprehensive system of safety net providers who deliver high quality direct health care and support services to over half a million PLWH—more than 50 percent of all people living with diagnosed HIV in the United States. All parts of the RWHAP must follow the legislative requirements for the establishment of clinical quality management programs to assess their HIV services according to the most recent HHS guidelines and to develop strategies to improve access to quality HIV services. The HIVQM Module supports recipients and subrecipients in their clinical quality management, performance measurement, service delivery, and monitoring of client health outcomes; and supports the requirement imposed by the Uniform Administrative Requirements, Cost Principles, and Audit Requirements that recipients relate performance accomplishments of their Federal awards. 45 CFR 75.301. The module is accessible via the Ryan White Services Report, an existing online portal that RWHAP recipients already use for required data collection of their services. While the use of the module is voluntary for RWHAP recipients, its use is strongly encouraged. The HRSA performance measures are comprised of the following categories: (1) Core, (2) all ages, (3) adolescent/ adult, (4) HIV-infected children, (5) HIV-exposed children, (6) medical case management, (7) oral health, (8) AIDS drug assistance program, and (9) systems level performance measures. Recipients can choose the performance measures they want to monitor and may enter data on their measures into the module up to 4 times a year and then generate reports to assess their performance. Recipients may also compare their performance against other recipients regionally and nationally. Need and Proposed Use of the Information: The HIVQM Module provides recipients an easy-to-use and E:\FR\FM\14MRN1.SGM 14MRN1

Agencies

[Federal Register Volume 84, Number 50 (Thursday, March 14, 2019)]
[Notices]
[Pages 9354-9362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04710]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]

Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 051

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a publication containing modifications the Agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
Recognized Consensus Standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 051'' (Recognition List Number: 051), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.

DATES: Submit either electronic or written comments on the notice at
any time. These modifications to the list of recognized standards are
applicable March 14, 2019.

ADDRESSES: You may submit comments on the current list of FDA
Recognized Consensus Standards at any time as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of
1997: Modifications to the List of Recognized Standards, Recognition
List Number: 051.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday. FDA will
consider any comments received in determining whether to amend the
current listing of modifications to the list of recognized standards,
Recognition List Number: 051.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
An electronic copy of Recognition List Number: 051 is available on
the internet

[[Page 9355]]

at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section IV for electronic access to the
searchable database for the current list of FDA recognized consensus
standards, including Recognition List Number: 051 modifications and
other standards related information. Submit written requests for a
single hard copy of the document entitled ``Modifications to the List
of Recognized Standards, Recognition List Number: 051'' to Scott
Colburn (see FOR FURTHER INFORMATION CONTACT). Send one self-addressed
adhesive label to assist that office in processing your request or Fax
your request to 301-847-8144.

FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287,
CDRHStandardsStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

Section 204 of the Food and Drug Administration Modernization Act
of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514
allows FDA to recognize consensus standards developed by international
and national organizations for use in satisfying portions of device
premarket review submissions or other requirements.
In the Federal Register of September 14, 2018 (83 FR 46738), FDA
announced the availability of a guidance entitled ``Appropriate Use of
Voluntary Consensus Standards in Premarket Submissions for Medical
Devices.'' The guidance describes how FDA has implemented its standard
recognition program and is available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077295.pdf. Modifications to the initial list of recognized
standards, as published in the Federal Register, can be accessed at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains hypertext
markup language (HTML) and portable document format (PDF) versions of
the list of FDA Recognized Consensus Standards. Additional information
on the Agency's standards program is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm.

II. Modifications to the List of Recognized Standards, Recognition List
Number: 051

FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency is recognizing for
use in premarket submissions and other requirements for devices. FDA is
incorporating these modifications to the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA is using
the term ``Recognition List Number: 051'' to identify the current
modifications.
In table 1, FDA describes the following modifications: (1) The
withdrawal of standards and their replacement by others, if applicable;
(2) the correction of errors made by FDA in listing previously
recognized standards; and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
In section III, FDA lists modifications the Agency is making that
involve the initial addition of standards not previously recognized by
FDA.

Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
Replacement
Old recognition No. recognition Title of standard \1\ Change \2\
No.
----------------------------------------------------------------------------------------------------------------
A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
1-104.............................. 1-141 ISO 80601-2-13 First edition 2011-08- Withdrawn and
11 Medical electrical equipment-- replaced with newer
Part 2-13: Particular requirements version including
for basic safety and essential amendment. Extent of
performance of an anaesthetic Recognition.
workstation [Including: AMENDMENT 1
(2015) and AMENDMENT 2 (2018)].
1-108.............................. .............. ANSI/AAMI/ISO 5361:2012 Anaesthetic Withdrawn. See 1-118.
and respiratory equipment--Tracheal
tubes and connectors.
1-110.............................. .............. ANSI/AAMI/ISO 5366-1:2000 Withdrawn. See 1-117.
Anaesthetic and respiratory
equipment--Tracheostomy tubes--Part
1: Tubes and connectors for use in
adults.
1-111.............................. .............. ANSI/AAMI/ISO 5366-3:2001 Withdrawn. See 1-117.
Anaesthetic and respiratory
equipment--Tracheostomy Tubes--Part
3: Paediatric Tracheostomy Tubes.
1-114.............................. .............. ISO 18835 First Edition 2015-04-01 Extent of
Inhalational Anaesthesia Systems-- Recognition.
Draw-over Anaesthetic Systems.
1-117.............................. .............. ISO 5366 First edition 2016-10-01 Extent of
Anaesthetic and respiratory Recognition.
equipment--Tracheostomy tubes and
connectors.
1-118.............................. .............. ISO 5361 Third edition 2016-09-01 Extent of
Anaesthetic and respiratory Recognition.
equipment--Tracheal tubes and
connectors.
1-120.............................. .............. ISO 18190 First edition 2016-11-01 Extent of
Anaesthetic and respiratory Recognition.
equipment--General requirements for
airways and related equipment.
1-138.............................. .............. ISO 80601-2-74 First edition 2017-05 Extent of
Medical electrical equipment--Part Recognition.
2-74: Particular requirements for
basic safety and essential
performance of respiratory
humidifying equipment.
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-136.............................. .............. ASTM E1262-88 (Reapproved 2018) Reaffirmation.
Standard Guide for Performance of
Chinese Hamster Ovary Cell/
Hypoxanthine Guanine Phosphoribosyl
Transferase Gene Mutation Assay.
2-141.............................. .............. ASTM F1984-99 (Reapproved 2018) Reaffirmation.
Standard Practice for Testing for
Whole Complement Activation in
Serum by Solid Materials.

[[Page 9356]]

2-145.............................. .............. ASTM F1439-03 (Reapproved 2018) Reaffirmation.
Standard Guide for Performance of
Lifetime Bioassay for the
Tumorigenic Potential of Implant
Materials.
2-220.............................. 2-258 ISO 10993-1 Fifth edition 2018-08 Withdrawn and
Biological evaluation of medical replaced with newer
devices--Part 1: Evaluation and version.
testing within a risk management
process.
2-251.............................. 2-259 USP 41-NF36:2018 <87> Biological Withdrawn and
Reactivity Test, In Vitro--Direct replaced with newer
Contact Test. version.
2-252.............................. 2-260 USP 41-NF36:2018 <87> Biological Withdrawn and
Reactivity Test, In Vitro--Elution replaced with newer
Test. version.
2-253.............................. 2-261 USP 41-NF36:2018 <88> Biological Withdrawn and
Reactivity Test, In Vivo. replaced with newer
version.
2-254.............................. 2-262 USP 41-NF36:2018 <151> Pyrogen Test Withdrawn and
(USP Rabbit Test). replaced with newer
version. Extent of
Recognition.
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-44............................... .............. AAMI BP22:1994 (R2016) Blood Reaffirmation.
Pressure Transducers.
3-52............................... .............. ANSI/AAMI EC12:2000/(R) 2015 Reaffirmation.
Disposable ECG electrodes.
3-55............................... .............. ASTM F1830-97 (Reapproved 2017) Reaffirmation.
Standard Practice for Selection of
Blood for in vitro Evaluation of
Blood Pumps.
3-56............................... .............. ASTM F1841-97 (Reapproved 2017) Reaffirmation. Extent
Standard Practice for Assessment of of Recognition.
Hemolysis in Continuous Flow Blood
Pumps.
3-66............................... .............. ASTM F2081-06 (Reapproved 2017) Reaffirmation.
Standard Guide for Characterization
and Presentation of the Dimensional
Attributes of Vascular Stents.
3-79............................... .............. ASTM F2079-09 (Reapproved 2017) Reaffirmation.
Standard Test Method for Measuring
Intrinsic Elastic Recoil of Balloon-
Expandable Stents.
3-86............................... .............. ASTM F2394-07 (Reapproved 2017) Reaffirmation. Extent
Standard Guide for Measuring of Recognition.
Securement of Balloon Expandable
Vascular Stent Mounted on Delivery
System.
3-99............................... .............. AAMI TIR 42:2010 Evaluation of Extent of
Particulates Associated with Recognition.
Vascular Medical Devices.
3-122.............................. .............. IEC 81060-2 Second edition 2013-05- Extent of
01 Non-invasive sphygmomanometers-- Recognition.
Part 2: Clinical validation of
automated measurement type.
3-123.............................. .............. IEC 80601-2-30 Edition 2.0 2018-03 Title change. Extent
Medical electrical equipment--Part of recognition.
2-30: Particular requirements for
the basic safety and essential
performance of automated non-
invasive sphygmomanometers.
3-124.............................. .............. ISO 7199:2009 Cardiovascular Withdrawn.
implants and artificial organs--
Blood gas exchangers (oxygenators).
3-126.............................. .............. IEC 60601-2-27 Edition 3.0 2011-03 Extent of
Medical electrical equipment--Part recognition.
2-27: Particular requirements for
the basic safety and essential
performance of electrocardiographic
monitoring equipment.
3-127.............................. .............. ANSI/AAMI/IEC 60601-2-47:2012/(R) Reaffirmation.
2016 Medical electrical equipment--
Part 2-47: Particular requirements
for the basic safety and essential
performance of ambulatory
electrocardiographic systems.
3-138.............................. .............. ASTM F2942-13 Standard Guide for the Extent of
In Vitro Axial, Bending, and Recognition.
Rotational Durability Test of
Vascular Stents.
3-142.............................. .............. ISO/TS 17137 First edition 2014-05- Extent of
15 Cardiovascular implants and Recognition.
extracorporeal systems--
Cardiovascular absorbable implants.
----------------------------------------------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-126.............................. 4-248 ISO 10477 Third edition 2018-06 Withdrawn and
Dentistry--Polymer-based crown and replaced with newer
veneering materials. version.
4-150.............................. 4-249 ANSI/ADA Standard No. 19--2018 Withdrawn and
Elastomeric Impression Materials. replaced with newer
version.
4-162.............................. .............. ANSI S3.4-2007 (Reaffirmed 2017) Reaffirmation.
American National Standard
Procedure for the Computation of
Loudness of Steady Sounds.
4-163.............................. .............. ANSI S3.5-1997 (Reaffirmed 2017) Reaffirmation.
American National Standard Methods
for Calculation of the Speech
Intelligibility Index.
4-171.............................. .............. ANSI S3.37-1987 (Reaffirmed 2017) Reaffirmation.
American National Standard
Preferred Earhook Nozzle Thread for
Postauricular Hearing Aids.
4-213.............................. 4-250 ISO 7494-1 Third edition 2018-06 Withdrawn and
Dentistry--Stationary dental units replaced with newer
and dental patient chairs--Part 1: version.
General requirements.
4-217.............................. .............. ANSI/ASA S3.36-2012 (Reaffirmed Reaffirmation.
2018) American National Standard
Specification for a Manikin for
Simulated in-situ Airborne Acoustic
Measurements.
4-223.............................. 4-251 ISO 6872 Fourth edition 2015-06-01 Withdrawn and
Dentistry--Ceramic materials replaced with newer
[including AMENDMENT 1 2018-04]. version including
amendment.
4-226.............................. 4-252 ISO 10650 Second edition 2018-08 Withdrawn and
Dentistry--Powered polymerization replaced with newer
activators. version.
----------------------------------------------------------------------------------------------------------------

[[Page 9357]]

E. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-39............................... 5-120 IEC 60812 Edition 3.0 2018-08 Withdrawn and
Failure modes and effects analysis replaced with newer
(FMEA and FMECA). version. Title
change.
5-63............................... 5-121 ISO 80369-1 Second edition 2018-11 Withdrawn and
Small-bore connectors for liquids replaced with newer
and gases in healthcare version.
applications--Part 1: General
requirements.
5-105.............................. .............. ISO 16142-1 First edition 2016-03-01 Withdrawn.
Medical devices--Recognized
essential principles of safety and
performance of medical devices--
Part 1: General essential
principles and additional specific
essential principles for all non-
IVD medical devices and guidance on
selection of standards.
----------------------------------------------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-13.............................. 19-32 IEC 62133-1 Edition 1.0 2017-02 Withdrawn and
Secondary cells and batteries replaced with newer
containing alkaline or other non- version. Title
acid electrolytes--Safety change.
requirements for portable sealed
secondary cells, and for batteries
made from them, for use in portable
applications--Part 1: Nickel
systems.
19-33 IEC 62133-2 Edition 1.0 2017-02
Secondary cells and batteries
containing alkaline or other non-
acid electrolytes--Safety
requirements for portable sealed
secondary cells, and for batteries
made from them, for use in portable
applications--Part 2: Lithium
systems.
19-18.............................. 19-34 IEC 61010-1 Edition 3.1 2017-01 Withdrawn and
Safety requirements for electrical replaced with newer
equipment for measurement, control, version.
and laboratory use--Part 1: General
requirements.
----------------------------------------------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-239.............................. 6-410 ISO 8536-6 Third edition 2016-12-01 Withdrawn and
Infusion equipment for medical use-- replaced with newer
Part 6: Freeze drying closures for version.
infusion bottles.
6-338.............................. .............. ASTM D7866-14 Standard Specification Extent of
for Radiation Attenuating recognition.
Protective Gloves.
6-383.............................. 6-411 ASTM D6499-18 Standard Test Method Withdrawn and
for Immunological Measurement of replaced with newer
Antigenic Protein in Hevea Natural version.
Rubber (HNR) and its Products.
6-391.............................. 6-412 USP 41-NF36:2018 Sodium Chloride Withdrawn and
Irrigation. replaced with newer
version.
6-392.............................. 6-413 USP 41-NF36:2018 Sodium Chloride Withdrawn and
Injection. replaced with newer
version.
6-393.............................. 6-414 USP 41-NF36:2018 Nonabsorbable Withdrawn and
Surgical Suture. replaced with newer
version.
6-394.............................. 6-415 USP 41-NF36:2018 <881> Tensile Withdrawn and
Strength. replaced with newer
version.
6-395.............................. 6-416 USP 41-NF36:2018 <861> Sutures-- Withdrawn and
Diameter. replaced with newer
version.
6-396.............................. 6-417 USP 41-NF36:2018 <871> Sutures-- Withdrawn and
Needle Attachment. replaced with newer
version.
6-397.............................. 6-418 USP 41-NF36:2018 Sterile Water for Withdrawn and
Irrigation. replaced with newer
version.
6-398.............................. 6-419 USP 41-NF36:2018 Heparin Lock Flush Withdrawn and
Solution. replaced with newer
version.
6-399.............................. 6-420 USP 41-NF36: 2018 Absorbable Withdrawn and
Surgical Suture. replaced with newer
version.
----------------------------------------------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-139.............................. .............. CLSI QMS24 3rd Edition September Title change.
2016 Replaces GP27-A2 and GP29-A2.
Using Proficiency Testing and
Alternative Assessment to Improve
Medical Laboratory Quality.
7-178.............................. .............. CLSI M22-A3 Vol. 24 No. 19 Replaces Extent of
M22-A2 Vol. 16 No. 16 Quality recognition.
Control for Commercially Prepared
Microbiological Culture Media;
Approved Standard--Third Edition.
7-200.............................. 7-285 CLSI M48 2nd Edition Laboratory Withdrawn and
Detection and Identification of replaced with a
Mycobacteria. newer version.
7-215.............................. .............. CLSI M44-A2 Vol. 29 No. 17 Replaces Extent of
MM44-A Vol. 24 No. 15 Method for recognition.
Antifungal Disk Diffusion
Susceptibility Testing of Yeast;
Approved Guideline--Second Edition.
7-222.............................. .............. CLSI M24-A2 (Replaces M24-A) Extent of
Susceptibility Testing of recognition.
Mycobacteria, Nocardiae and other
Aerobic Actinomycetes; Approved
Standards--Second Edition.

[[Page 9358]]

7-228.............................. 7-286 CLSI M11 9th Edition Methods for Withdrawn and
Antimicrobial Susceptibility replaced with a
Testing of Anaerobic Bacteria. newer version.
Extent of
recognition.
7-232.............................. .............. CLSI MM05-A2 Vol. 32 No. 6 Replaces Extent of
MM05-A Vol. 23 No. 17 Nucleic Acid recognition.
Amplification Assays for Molecular
Hematopathology; Approved
Guideline--Second Edition.
7-262.............................. .............. CLSI M45 3rd Edition Methods for Extent of
Antimicrobial Dilution and Disk recognition.
Susceptibility Testing of
Infrequently Isolated or Fastidious
Bacteria.
7-269.............................. .............. CLSI MM23 1st Edition Molecular Extent of
Diagnostic Methods for Solid Tumors recognition.
(Nonhematological Neoplasms).
7-282.............................. .............. CLSI M60 1st Edition Performance Withdrawn. Duplicate
Standards for Antifungal version.
Susceptibility Testing of Yeasts.
----------------------------------------------------------------------------------------------------------------
I. Materials
----------------------------------------------------------------------------------------------------------------
8-179.............................. .............. ASTM F754-08 (Reapproved 2015) Extent of
Standard Specification for recognition.
Implantable Polytetrafluoroethylene
(PTFE) Sheet, Tube, and Rod Shapes
Fabricated from Granular Molding
Powders.
8-335.............................. 8-480 ASTM F2063-18 Standard Specification Withdrawn and
for Wrought Nickel-Titanium Shape replaced with newer
Memory Alloys for Medical Devices version.
and Surgical Implants.
8-345.............................. 8-481 ASTM F1314-18 Standard Specification Withdrawn and
for Wrought Nitrogen Strengthened replaced with newer
22 Chromium--13 Nickel--5 version.
Manganese--2.5 Molybdenum Stainless
Steel Alloy Bar and Wire for
Surgical Implants (UNS S20910).
8-365.............................. 8-482 ASTM D1505-18 Standard Test Method Withdrawn and
for Density of Plastics by the replaced with newer
Density-Gradient Technique. version.
8-371.............................. 8-483 ASTM F601-18 Standard Practice for Withdrawn and
Fluorescent Penetrant Inspection of replaced with newer
Metallic Surgical Implants. version.
8-375.............................. 8-484 ASTM F2066-18 Standard Specification Withdrawn and
for Wrought Titanium-15 Molybdenum replaced with newer
Alloy for Surgical Implant version.
Applications (UNS R58150).
8-462.............................. 8-485 ASTM F3260-18 Standard Test Method Withdrawn and
for Determining the Flexural replaced with newer
Stiffness of Medical Textiles. version.
----------------------------------------------------------------------------------------------------------------
J. Nanotechnology
----------------------------------------------------------------------------------------------------------------
18-2............................... .............. ASTM E2535-07 (Reapproved 2018) Reaffirmation.
Standard Guide for Handling Unbound
Engineered Nanoscale Particles in
Occupational Settings.
18-5............................... .............. ASTM E2859-11 (Reapproved 2017) Reaffirmation.
Standard Guide for Size Measurement
of Nanoparticles Using Atomic Force
Microscopy.
18-6............................... .............. ASTM E2865-12 (Reapproved 2018) Reaffirmation.
Standard Guide for Measurement of
Electrophoretic Mobility and Zeta
Potential of Nanosized Biological
Materials.
18-7............................... .............. ASTM E2834-12 (Reapproved 2018) Reaffirmation.
Standard Guide for Measurement of
Particle Size Distribution of
Nanomaterials in Suspension by
Nanoparticle Tracking Analysis
(NTA).
18-8............................... .............. ASTM E2578-07 (Reapproved 2018) Reaffirmation.
Standard Practice for Calculation
of Mean Sizes/Diameters and
Standard Deviations of Particle
Size Distributions.
----------------------------------------------------------------------------------------------------------------
K. Neurology
----------------------------------------------------------------------------------------------------------------
17-14.............................. .............. ANSI/AAMI NS4:2013/(R) 2017 Reaffirmation.
Transcutaneous electrical nerve
stimulators.
----------------------------------------------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
----------------------------------------------------------------------------------------------------------------
9-68............................... .............. ISO 23409 First edition 2011-02-15 Extent of
Male Condoms--Requirements and test Recognition.
methods for condoms made from
synthetic materials.
9-80............................... 9-121 IEC 60601-2-16 Edition 5.0 2018-04 Withdrawn and
Medical electrical equipment--Part replaced with newer
2-16: Particular requirements for version.
the basic safety and essential
performance of haemodialysis,
haemodiafiltration and
haemofiltration equipment.
9-89............................... .............. ANSI AAMI ISO 8638:2010 (R2015) Reaffirmation.
Cardiovascular implants and
extracorporeal systems--
Extracorporeal blood circuit for
hemodialyzers, hemodiafilters and
hemofilters.
9-93............................... 9-122 ISO 25841 Third edition 2017-08 Withdrawn and
Female condoms--Requirements and replaced with newer
test methods. version.
9-111.............................. .............. ISO 4074 Third edition 2015-10-15 Extent of
Natural latex rubber condoms-- Recognition.
Requirements and test methods.
9-112.............................. .............. ASTM D3492-16 Standard Specification Extent of
for Rubber Contraceptives (Male Recognition.
Condoms).
----------------------------------------------------------------------------------------------------------------
M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-74.............................. .............. ISO 10940 Second edition 2009-08-01 Extent of
Ophthalmic instruments--Fundus recognition.
cameras.

[[Page 9359]]

10-85.............................. .............. ISO 11980 Third edition 2012-11-15 Title change. Extent
Corrected version 2012-12-01 of recognition.
Ophthalmic optics--Contact lenses
and contact lens care products--
Guidance for clinical
investigations.
10-86.............................. .............. ISO 14729 First edition 2001-04-15 Extent of
Ophthalmic optics--Contact lens recognition.
care products--Microbiological
requirements and test methods for
products and regimens for hygienic
management of contact lenses
[Including: Amendment 1 (2010)].
10-89.............................. .............. ANSI Z80.7-2013 (R2018) American Reaffirmation. Extent
National Standard for Ophthalmic of recognition.
Optics--Intraocular Lenses.
10-93.............................. .............. ANSI Z80.27-2014 American National Extent of
Standard for Ophthalmics-- recognition.
Implantable Glaucoma Devices.
10-108............................. .............. ISO 18369-2 Third Edition 2017-08 Extent of
Ophthalmic optics--Contact lenses-- recognition.
Part 2: Tolerances.
----------------------------------------------------------------------------------------------------------------
N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-184............................. .............. ISO 8827 First edition 1988-10-15 Extent of
Implants for surgery--Staples with Recognition.
parallel legs for orthopaedic use--
General requirements.
11-234............................. 11-342 ASTM F732-17 Standard Test Method Withdrawn and
for Wear Testing of Polymeric replaced with newer
Materials Used in Total Joint version.
Prostheses.
11-243............................. 11-343 ASTM F2346-18 Standard Test Methods Withdrawn and
for Static and Dynamic replaced with newer
Characterization of Spinal version.
Artificial Discs.
11-272............................. .............. ASTM F1714-96 (Reapproved 2018) Reaffirmation.
Standard Guide for Gravimetric Wear
Assessment of Prosthetic Hip
Designs in Simulator Devices.
11-295............................. 11-344 ASTM F2580-18 Standard Practice for Withdrawn and
Evaluation of Modular Connection of replaced with newer
Proximally Fixed Femoral Hip version.
Prosthesis.
11-302............................. 11-345 ASTM F1717-18 Standard Test Methods Withdrawn and
for Spinal Implant Constructs in a replaced with newer
Vertebrectomy Model. version.
11-323............................. 11-346 ASTM F2706-18 Standard Test Methods Withdrawn and
for Occipital-Cervical and replaced with newer
Occipital-Cervical-Thoracic Spinal version.
Implant Constructs in a
Vertebrectomy Model.
11-331............................. 11-347 ASTM F2077-18 Test Methods for Withdrawn and
Intervertebral Body Fusion Devices. replaced with newer
version.
----------------------------------------------------------------------------------------------------------------
O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-29.............................. 16-204 ISO 7176-6 Third edition 2018-06 Withdrawn and
Wheelchairs--Part 6: Determination replaced with newer
of maximum speed of electrically version.
powered wheelchairs.
16-202............................. 16-205 RESNA WC-4:2017 Standard for Withdrawn and
Wheelchairs Volume 4: Wheelchairs replaced with new
and Transportation. recognition number.
----------------------------------------------------------------------------------------------------------------
P. Radiology
----------------------------------------------------------------------------------------------------------------
12-102............................. .............. ANSI/IES RP-27.2-00/R17 Recommended Reaffirmation.
Practice for Photobiological Safety
for Lamps and Lamp Systems--
Measurement Techniques.
12-179............................. 12-321 ANSI/IES RP-27.3-17 Recommended Withdrawn and
Practice for Photobiological Safety replaced with newer
for Lamps--Risk Group version.
Classification and Labeling.
12-231............................. 12-322 NEMA MS 5-2018 Determination of Withdrawn and
Slice Thickness in Diagnostic replaced with newer
Magnetic Resonance Imaging. version.
12-247............................. 12-323 ISO 11990 Third edition 2018-08 Withdrawn and
Lasers and laser-related equipment-- replaced with newer
Determination of laser resistance version. Title
of tracheal tube shaft and tracheal change.
tube cuffs.
12-305............................. 12-324 ISO 13694 Third edition 2018-11 Withdrawn and
Optics and Photonics--Lasers and replaced with newer
laser-related equipment--Test version.
methods for laser beam power
(energy) density distribution.
----------------------------------------------------------------------------------------------------------------
Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-32.............................. .............. ANSI AAMI IEC 62304:2006 Medical Transition period.
device software--Software life
cycle processes.
13-79.............................. .............. IEC 62304 Edition 1.1 2015-06 Title change and
CONSOLIDATED VERSION Medical device transition period.
software--Software life cycle
processes.
----------------------------------------------------------------------------------------------------------------
R. Sterility
----------------------------------------------------------------------------------------------------------------
14-314............................. .............. ANSI/AAMI ST67:2011/(R) 2017 Reaffirmation.
Sterilization of health care
products--Requirements and guidance
for selecting a sterility assurance
level (SAL) for products labeled
`sterile'.
14-311............................. 14-518 ANSI/AAMI ST55:2016 Table-top steam Withdrawn and
sterilizers. replaced with newer
version.
14-396............................. .............. ANSI/AAMI ST77:2013/(R) 2018 Reaffirmation.
Containment devices for reusable
medical device sterilization.

[[Page 9360]]

14-410............................. 14-519 ASTM F17-18 Standard Terminology Withdrawn and
Relating to Primary Barrier replaced with newer
Packaging. version.
14-503............................. 14-520 USP 41-NF36:2018 <61> Withdrawn and
Microbiological Examination of replaced with newer
Nonsterile Products: Microbial version.
Enumeration Tests.
14-504............................. 14-521 USP 41-NF36:2018 <71> Sterility Withdrawn and
Tests. replaced with newer
version.
14-505............................. 14-522 USP 41-NF36:2018 <85> Bacterial Withdrawn and
Endotoxins Test. replaced with newer
version.
14-506............................. 14-523 USP 41-NF36:2018 <161> Medical Withdrawn and
Devices--Bacterial Endotoxin and replaced with newer
Pyrogen Tests. version.
14-507............................. 14-524 USP 41-NF36:2018 <62> Withdrawn and
Microbiological Examination of replaced with newer
Nonsterile Products: Tests for version.
Specified Microorganisms.
14-508............................. 14-525 USP 41-NF36:2018 <55> Biological Withdrawn and
Indicators--Resistance Performance replaced with newer
Tests. version.
14-509............................. 14-526 USP 41-NF36:2018 <1229.5> Biological Withdrawn and
Indicators for Sterilization. replaced with newer
version.
----------------------------------------------------------------------------------------------------------------
S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-47.............................. .............. ISO 22442-3 First edition 2007-12-15 Extent of
Medical devices utilizing animal Recognition.
tissues and their derivatives--Part
3: Validation of the elimination
and/or inactivation of viruses and
transmissible spongiform
encephalopathy (TSE) agents.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.
\2\ Standards that are ``Withdrawn'' or ``Withdrawn and replaced with newer version'' will have a transition
period with an expiration date as noted in the recognition database https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.

III. Listing of New Entries

In table 2, FDA provides the listing of new entries and consensus
standards added as modifications to the list of recognized standards
under Recognition List Number: 051.

Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No.
Recognition No. Title of standard \1\ and date
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
No new entries at this
time..
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
No new entries at this
time..
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-157......................... Cardiovascular ANSI/AAMI/ISO
implants--Endovascula 25539-1: 2017.
r devices--Part 1:
Endovascular
prostheses.
3-158......................... Standard Guide for ASTM F3320-18.
Coating
Characterization of
Drug Coated Balloons.
3-159......................... Cardiovascular ISO 5910 First
implants and edition 2018-
extracorporeal 06.
systems--Cardiac
valve repair devices.
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-253......................... Polymer-based ANSI/ADA
Restorative Materials. Standard No. 27-
2016.
4-254......................... Athletic Mouth ANSI/ADA
Protectors and Standard No. 99-
Materials. 2001
(Reaffirmed
2013).
4-255......................... Dental CAD/CAM ANSI/ADA
Machinable Zirconia Standard No.
Blanks. 131-2015.
4-256......................... Scanning Accuracy of ANSI/ADA
Dental Chairside and Standard No.
Laboratory CAD/CAM 132-2015.
Systems.
4-257......................... Dentistry--Fluoride ISO 17730 First
varnishes. edition 2014-11-
01.
------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
5-122......................... Assessing Credibility ASME V&V 40-
of Computational 2018.
Modeling Through
Verification and
Validation:
Application to
Medical Devices.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
No new entries at this
time..
------------------------------------------------------------------------

[[Page 9361]]

G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
No new entries at this
time..
------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
No new entries at this
time..
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-486......................... Standard Guide for in ASTM F3268-18.
vitro Degradation
Testing of Absorbable
Metals.
8-487......................... Additive ISO/ASTM52910-
manufacturing--Design 18.
-Requirements,
guidelines and
recommendations.
8-488......................... Standard for Additive ASTM F3301-18a.
Manufacturing--Post
Processing Methods--
Standard
Specification for
Thermal Post-
Processing Metal
Parts Made Via Powder
Bed Fusion.
8-489......................... Standard for Additive ASTM F3302-18.
Manufacturing--Finish
ed Part Properties--
Standard
Specification for
Titanium Alloys via
Powder Bed Fusion.
8-490......................... Standard for Additive ASTM F3303-18.
Manufacturing--Proces
s Characteristics and
Performance: Practice
for Metal Powder Bed
Fusion Process to
Meet Critical
Applications.
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
18-11......................... Nanotechnologies--Nano ISO/TR 13121
material risk First edition
evaluation. 2011-05-15.
18-12......................... Nanotechnology--Nanopa ISO/TS 17200
rticles in powder First edition
form--Characteristics 2013-06-01.
and measurements.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
No new entries at this
time..
------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
No new entries at this
time..
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
10-114........................ American National ANSI Z80.28-
Standard for 2017.
Ophthalmics--Methods
of Reporting Optical
Aberrations of Eyes.
10-115........................ American National ANSI Z80.29-
Standard for 2015.
Ophthalmics--Accommod
ative Intraocular
Lenses.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
11-348........................ Implants for surgery-- ISO 19227 First
Cleanliness of edition 2018-
orthopedic implants-- 03.
General requirements.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
16-206........................ Walking aids ISO 11199-2
manipulated by both Second edition
arms--Requirements 2005-04-15.
and test methods--
Part 2: Rollators.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
No new entries at this
time..
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
13-105........................ Classification of ANSI/AAMI
defects in health SW91:2018.
software.
13-106........................ Health informatics-- IEEE Std 11073-
Point-of-care medical 10207-2017.
device communication
Part 10207: Domain
Information and
Service Model for
Service-Oriented
Point-of-Care Medical
Device Communication.
13-107........................ Health informatics-- ISO/IEEE 11073-
Point-of-care medical 20702 First
device communication-- edition 2018-
Part 20702: Medical 09.
devices communication
profile for web
services.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
No new entries at this
time..
------------------------------------------------------------------------

[[Page 9362]]

S. Tissue Engineering
------------------------------------------------------------------------
15-56......................... Standard Test Method ASTM F3224-17.
for Evaluating Growth
of Engineered
Cartilage Tissue
using Magnetic
Resonance Imaging.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.

IV. List of Recognized Standards

FDA maintains the current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. Such
standards are those that FDA has recognized by notice published in the
Federal Register or that FDA has decided to recognize but for which
recognition is pending (because a periodic notice has not yet appeared
in the Federal Register). FDA will announce additional modifications
and revisions to the list of recognized consensus standards, as needed,
in the Federal Register once a year, or more often if necessary.
Beginning with list 52, FDA will no longer announce in the Federal
Register updates to current recognized standards for reapproved or
reaffirmed standards because reapproved or reaffirmed standards have
not changed from the recognized standard. International and national
standards developing organizations use the designations of reapproved
or reaffirmed to indicate a standard has been reviewed but no changes
were made to the standard at that time.

V. Recommendation of Standards for Recognition by FDA

Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to
CDRHStandardsStaff@fda.hhs.gov. To be considered, such recommendations
should contain, at a minimum, the following information available at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123739.htm.

Dated: March 8, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04710 Filed 3-13-19; 8:45 am]
BILLING CODE 4164-01-P

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