Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 038, 4274-4280 [2015-01420]
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Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices
classified in class II. They were
originally classified before the
enactment of provisions of the Safe
Medical Devices Act of 1990 (Pub. L.
101–629), which broadened the
definition of class II devices and now
permit FDA to establish special controls
beyond performance standards,
including guidance documents, to help
provide reasonable assurance of the
safety and effectiveness of such devices.
In December 2000, Congress enacted
Public Law 106–554, which directed
FDA to ‘‘reexamine existing condom
labels’’ and ‘‘determine whether the
labels are medically accurate regarding
the overall effectiveness or lack of
effectiveness in preventing sexually
transmitted diseases * * *.’’ In
response, FDA recommended labeling
intended to provide important
information for condom users, including
the extent of protection provided by
condoms against various types of
sexually transmitted diseases.
Respondents to this collection of
information are manufacturers and
repackagers of male condoms made of
natural rubber latex without spermicidal
lubricant. FDA expects approximately
five new manufacturers or repackagers
to enter the market yearly and to
collectively have a third-party
disclosure burden of 60 hours. The
number of respondents cited in table 1
of this document is based on FDA’s
database of premarket submissions and
the electronic registration and listing
database. The average burden per
disclosure was derived from a study
performed for FDA by Eastern Research
Group, Inc., an economic consulting
firm, to estimate the impact of the 1999
over-the-counter (OTC) human drug
labeling requirements final rule (64 FR
13254, March 17, 1999). Because the
packaging requirements for condoms are
similar to those of many OTC drugs, we
believe the burden to design the labeling
for OTC drugs is an appropriate proxy
for the estimated burden to design
condom labeling.
The special controls guidance
document also refers to previously
approved collections of information
found in FDA regulations. The
collections of information in 21 CFR
part 801 have been approved under
OMB control number 0910–0485; the
collections of information in 21 CFR
part 807 subpart E have been approved
under OMB control number 0910–0120;
and the collections of information in 21
CFR part 820 have been approved under
OMB control number 0910–0073.
The collection of information under
21 CFR 801.437 does not constitute a
‘‘collection of information’’ under the
Paperwork Reduction Act of 1995.
Rather, it is a ‘‘public disclosure of
information originally supplied by the
Federal Government to the recipient for
the purpose of disclosure to the public’’
(5 CFR 1320.3(c)(2)).
In the Federal Register of October 15,
2014 (79 FR 61874), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity
Number of
respondents
Number of
disclosures
per
respondent
Total
annual
disclosures
Average
burden per
disclosure
Total hours
Class II Special Controls Guidance Document: Labeling for Natural
Rubber Latex Condoms Classified Under 21 CFR 884.5300 .............
5
1
5
12
60
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Consensus Standards). This publication,
entitled ‘‘Modifications to the List of
Recognized Standards, Recognition List
Number: 038’’ (Recognition List
Number: 038), will assist manufacturers
who elect to declare conformity with
consensus standards to meet certain
requirements for medical devices.
[FR Doc. 2015–01403 Filed 1–26–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2004–N–0451]
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
038
Submit either electronic or
written comments concerning this
document at any time. See section VII
of this document for the effective date
of the recognition of standards
announced in this document.
ADDRESSES:
DATES:
Food and Drug Administration
asabaliauskas on DSK5VPTVN1PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing a
publication containing modifications
the Agency is making to the list of
standards FDA recognizes for use in
premarket reviews (FDA Recognized
SUMMARY:
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An electronic copy of
Recognition List Number: 038 is
available on the Internet at https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm. See section
VI of this document for electronic access
to the searchable database for the
current list of FDA recognized
consensus standards, including
Recognition List Number: 038
modifications and other standards
related information.
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Submit written requests for a single
copy of the document entitled
‘‘Modifications to the List of Recognized
Standards, Recognition List Number:
038’’ to the Division of Industry and
Consumer Education, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4613, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 301–847–8149.
Submit electronic comments on this
document to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Scott A. Colburn, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3632, Silver Spring,
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MD 20993, 301–796–6287, standards@
cdrh.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug
Administration Modernization Act of
1997 (FDAMA) (Pub. L. 105–115)
amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the
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 a notice published in the Federal
Register of February 25, 1998 (63 FR
9561), FDA announced the availability
of a guidance entitled ‘‘Recognition and
Use of Consensus Standards.’’ The
notice described how FDA would
implement its standard recognition
program and provided the initial list of
recognized standards.
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. Both versions are publicly
accessible at the Agency’s Internet site.
See section VI for electronic access
information. Interested persons should
review the supplementary information
sheet for the standard to understand
fully the extent to which FDA
recognizes the standard.
II. Modifications to the List of
Recognized Standards, Recognition List
Number: 038
FDA is announcing the addition,
withdrawal, correction, and revision of
certain consensus standards the Agency
will recognize for use in premarket
submissions and other requirements for
devices. FDA will incorporate these
modifications in the list of FDA
Recognized Consensus Standards in the
Agency’s searchable database. FDA will
use the term ‘‘Recognition List Number:
038’’ to identify these 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
A. Anesthesia
1–57 ..................
............................
1–69 ..................
............................
1–70 ..................
............................
1–94 ..................
............................
ASTM F1101–90 (Reapproved 2003) Standard Specification for Ventilators Intended for Use During Anesthesia.
ASTM F1464–93 (Reapproved 2005) Standard Specification for Oxygen Concentrators for Domiciliary Use.
ASTM F1246–91 (Reapproved 2005) Standard Specification for
Electrically Powered Home Care Ventilators—Part 1: PositivePressure Ventilators and Ventilator Circuits.
ISO 8359 Second edition 1996–12–15, Oxygen concentrators for
medical use—safety requirements [including amendment 1 (2012)].
Withdrawn.
Withdrawn.
Withdrawn.
Withdrawn. See 1–102.
B. Biocompatibility
2–143 ................
2–213
2–144 ................
2–214
ASTM F1904–14 Standard Practice for the Biological Responses to
Particles in vivo.
ASTM F619–14 Standard Practice for Extraction of Medical Plastics.
Withdrawn and
newer version.
Withdrawn and
newer version.
replaced
with
replaced
with
C. Cardiovascular
3–88 ..................
............................
3–123 ................
............................
ASTM F2514–08 (Reapproved 2014) Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading.
IEC 80601–2–30 Edition 1.1 2013–07, Medical electrical equipment—Part 2–30: Particular requirements for the basic safety and
essential performance of automated non-invasive sphygmomanometers.
Reaffirmation.
Extent of recognition and Process
impacted.
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D. Dental/ENT
4–117 ................
............................
4–134 ................
4–213
4–135 ................
4–214
4–136 ................
............................
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ANSI/ADA Specification No. 12: 2002 (Reaffirmed 2008) Denture
base polymers.
ISO 7494–1 Second edition 2011–08–15 Dentistry—Dental units—
Part 1: General requirements and test methods.
ISO 10139–1 Second edition 2005–02–15, Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term
use [Including: Technical Corrigendum 1 (2006)].
ASTM F2504–05 (Reapproved 2014) Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices.
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Withdrawn.
Withdrawn and replaced with
newer version.
Withdrawn and replaced with
newer version including technical corrigendum.
Reaffirmation.
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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old
recognition No.
Replacement
recognition No.
Title of standard 1
Change
4–143 ................
4–215
ANSI/ADA Standard No. 96: 2012 Dental Water-based Cements ......
4–159 ................
4–216
4–170 ................
4–217
4–183 ................
............................
4–185 ................
............................
ANSI/IEEE ANSI C63.19–2011 American National Standard Methods
of Measurement of Compatibility between Wireless Communications Devices and Hearing Aids.
ANSI/ASA S3.36–2012 American National Standard Specification for
a Manikin for Simulated in-situ Airborne Acoustic Measurements.
ANSI/ASA S3.2–2009 (Reaffirmed 2014) American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems.
ANSI/ASA S3.45–2009 (Reaffirmed 2014) American National Standard Procedures for Testing Basic Vestibular Function.
Withdrawn and
newer version.
Withdrawn and
newer version.
replaced
with
replaced
with
Withdrawn and
newer version.
Reaffirmation.
replaced
with
replaced
with
Reaffirmation.
E. General I (Quality Systems/Risk Management (QS/RM))
5–48 ..................
............................
5–57 ..................
............................
5–62 ..................
............................
ANSI/ASQ Z1.9–2003 (R2013) Sampling Procedures and Tables for
Inspection by Variables for Percent Nonconforming.
ANSI/AAMI HE75:2009/(R)2013 Human factors engineering—Design
of medical devices.
ANSI/ASQ Z1.4–2003 (R2013) Sampling Procedures and Tables for
Inspection by Attributes.
Reaffirmation.
Reaffirmation.
Reaffirmation.
F. General Hospital/General Plastic Surgery (GH/GPS)
6–199 ................
6–335
6–217 ................
............................
6–228 ................
6–336
6–231 ................
6–337
ASTM F2101–14 Standard Test Method for Evaluating the Bacterial
Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a
Biological Aerosol of Staphylococcus aureus.
ASTM F1670/F1670M–08 (Reapproved 2014) epsiv;1 Standard
Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood.
IEC 60601–2–2 Edition 5.0 2009–02 Medical Electrical Equipment—
Part 2–2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High
Frequency Surgical Accessories [Including: Technical Corrigendum
1 (2014)].
ANSI/AAMI/IEC 60601–2–20:2009 Medical Electrical Equipment—
Part 2–20: Particular Requirements for the Basic Safety and Essential Performance of Infant Transport Incubators [Including: Erratum (2012)].
Withdrawn and
newer version.
Reaffirmation.
Withdrawn and replaced with
newer version including technical corrigendum.
Withdrawn and replaced with
newer version including erratum.
G. In Vitro Diagnostics (IVD)
7–84 ..................
7–162 ................
............................
............................
7–184 ................
7–250
CEN 13640, Stability Testing of In Vitro Diagnostic Reagents ............
CLSI POCT14–A (Formerly H49–A) Point-Of-Care Monitoring of
Anticoagulation Therapy; Approved Guideline.
CLSI M40–A2 Quality Control of Microbiological Transport Systems;
Approved Standard—Second Edition.
Withdrawn.
Withdrawn duplicate. See 7–112.
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
Withdrawn and
newer version.
replaced
with
replaced
with
H. Materials
8–380
8–124 ................
8–381
8–171 ................
............................
8–198 ................
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8–111 ................
8–382
8–207 ................
8–383
8–340 ................
8–384
8–357 ................
8–385
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ASTM F1160–14 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and
Composite Calcium Phosphate/Metallic Coatings.
ASTM F2052–14 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the
Magnetic Resonance Environment.
ASTM F1609–08 (Reapproved 2014) Standard Specification for Calcium Phosphate Coatings for Implantable Materials.
ASTM F2102–13 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants.
ASTM F1926/F1926M–14 Standard Test Method for Dissolution
Testing of Calcium Phosphate Granules, Fabricated Forms, and
Coatings.
ASTM F2026–14 Standard Specification for Polyetheretherketone
(PEEK) Polymers for Surgical Implant Applications.
ASTM F648–14 Standard Specification for Ultra-High-MolecularWeight Polyethylene Powder and Fabricated Form for Surgical Implants.
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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old
recognition No.
Replacement
recognition No.
Title of standard 1
Change
I. OB–GYN/Gastroenterology/Urology
9–6 ....................
9–95
9–45 ..................
............................
9–62 ..................
9–96
9–74 ..................
9–97
9–76 ..................
9–98
9–77 ..................
9–99
9–78 ..................
9–100
9–79 ..................
9–101
9–82 ..................
9–102
IEC 60601–2–36 Edition 2.0 2014–04 Medical electrical equipment—
Part 2–36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced
lithotripsy.
ASTM F2528¥06 (Reapproved 2014) Standard Test Methods for
Enteral Feeding Devices with a Retention Balloon.
IEC 60601–2–2 Edition 5.0 2009–02 Medical Electrical Equipment—
Part 2–2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High
Frequency Surgical Accessories [Including: Technical Corrigendum
1 (2014)].
ISO 13958 Third edition 2014–04–01 Concentrates for haemodialysis
and related therapies.
ISO 13959 Third edition 2014–04–01 Water for haemodialysis and
related therapies.
ISO 23500 Second edition 2014–04–01 Guidance for the preparation
and quality management of fluids for haemodialysis and related
therapies.
ISO 11663 Second edition 2014–04–01 Quality of dialysis fluid for
haemodialysis and related therapies.
ISO 26722 Second edition 2014–04–01 Water treatment equipment
for haemodialysis applications and related therapies.
ISO 4074 Second edition 2014–08–15 Natural rubber latex male
condoms—Requirements and test methods.
Withdrawn and
newer version.
replaced
with
Reaffirmation.
Withdrawn and replaced with
newer version including technical corrigendum.
Withdrawn and
newer version.
Withdrawn and
newer version.
Withdrawn and
newer version.
replaced
with
replaced
with
replaced
with
Withdrawn and replaced with a
newer version.
Withdrawn and replaced with a
newer version.
Withdrawn and replaced with
newer version.
J. Ophthalmic
10–49 ................
10–90
10–50 ................
10–91
10–80 ................
............................
ISO 11979–9 First edition 2006–09–01 Ophthalmic implants—Intraocular lenses—Part 9: Multifocal intraocular lenses [Including:
Amendment 1(2014)].
ISO 11979–10 First edition 2006–08–15 Ophthalmic implants—Intraocular lenses—Part 10: Phakic intraocular lenses [Including:
Amendment 1 (2014)].
ISO 18369–2 Second edition 2012–12–01 Ophthalmic optics—Contact lenses—Part 2: Tolerances.
Withdrawn and replaced with
newer version including amendment.
Withdrawn and replaced with
newer version including amendment.
Extent of recognition and relevant
guidance.
K. Orthopedic
11–196 ..............
11–281
11–213 ..............
11–282
11–260 ..............
11–283
11–263 ..............
11–284
ASTM F1672–14 Standard Specification for Resurfacing Patellar
Prosthesis.
ASTM F1223–14 Standard Test Method for Determination of Total
Knee Replacement Constraint.
ASTM F2943–14 Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants.
ASTM F2028–14 Standard Test Methods for Dynamic Evaluation of
Glenoid Loosening or Disassociation.
Withdrawn and replaced newer
version.
Withdrawn and replaced with
newer version.
Withdrawn and replaced with
newer version.
Withdrawn and replaced with
newer version.
L. Physical Medicine
16–189 ..............
16–193
ASME A18.1–2014 Safety Standard for Platform Lifts and Stairway
Chairlifts.
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
Withdrawn and
newer version.
replaced
with
replaced
with
M. Radiology
12–284
NEMA NU 1–2012 Performance Measurements of Gamma Cameras.
12–206 ..............
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12–181 ..............
12–285
12–230 ..............
............................
IEC 60601–2–1 Edition 3.1 2014–07 Medical electrical equipment—
Part 2–1: Particular requirements for the basic safety and essential
performance of electron accelerators in the range 1 MeV to 50
MeV.
NEMA XR 24–2008 (R2014) Primary User Controls for Interventional
Angiography X-Ray Equipment.
Reaffirmation.
N. Sterility
14–139 ..............
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ISO 14644–1 First edition 1999–05–01 Cleanrooms and associated
controlled environments—Part 1: Classification of air cleanliness.
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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old
recognition No.
Replacement
recognition No.
Title of standard 1
14–140 ..............
............................
14–141 ..............
............................
14–165 ..............
............................
14–166 ..............
............................
14–193 ..............
............................
14–194 ..............
............................
14–238 ..............
............................
14–242 ..............
............................
14–243 ..............
............................
14–274 ..............
............................
14–299 ..............
14–453
14–355 ..............
14–454
14–356 ..............
14–455
14–379 ..............
............................
14–389 ..............
............................
14–390 ..............
............................
ISO 14644–2 First edition 2000–09–15 Cleanrooms and associated
controlled environments—Part 2: Specifications for testing and
monitoring to prove continued compliance with ISO 14644–1.
ISO 14644–4 First edition 2001–04–01 Cleanrooms and associated
controlled environments—Part 4: Design, construction and start-up.
ISO 14644–5 First edition 2004–08–15 Cleanrooms and associated
controlled environments—Part 5: Operations.
ISO 14644–7 First edition 2004–10–01 Cleanrooms and associated
controlled environments—Part 7: Separative devices (clean air
hoods, gloveboxes, isolators and mini-environments).
ANSI/AAMI/ISO 11607–1:2006/(R)2010, Packaging for terminally
sterilized medical devices—Part 1: Requirements for materials,
sterile barrier systems, and packaging systems.
ANSI/AAMI/ISO 11607–2:2006/(R)2010, Packaging for terminally
sterilized medical devices—Part 2: Validation requirements for
forming, sealing and assembly processes.
AAMI/ANSI/ISO 11140–5:2007/(R)2012, Sterilization of health care
products—Chemical indicators—Part 5: Class 2 indicators for
Bowie and Dick air removal test sheets and packs.
ISO 14644–3 First edition 2005–12–15 Cleanrooms and associated
controlled environments—Part 3: Test methods.
ISO 14644–6 First edition Cleanrooms and associated controlled environments—Part 6: Vocabulary.
ANSI/AAMI/ISO 15882:2008/(R)2013, Sterilization of health care
products—Chemical indicators—Guidance for selection, use and
interpretation of results.
ASTM F2097–14 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products.
ISO 11607–1 First edition 2006–04–15 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile
barrier systems and packaging systems [Including: Amendment 1
(2014)].
ISO 11607–2 First edition 2006–04–15 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming,
sealing and assembly processes [Including: Amendment 1 (2014)].
ISO 14644–8 Second edition 2013–02–15 Cleanrooms and associated controlled environments—Part 8: Classification of air cleanliness by chemical concentration (ACC).
ISO 14644–9 First edition 2012–08–15 Cleanrooms and associated
controlled environments—Part 9: Classification of surface cleanliness by particle concentration.
ISO 14644–10 First edition 2013–03–01 Cleanrooms and associated
controlled environments—Part 10: Classification of surface cleanliness by chemical concentration.
1 All
Change
Relevant guidance.
Relevant guidance.
Relevant guidance.
Relevant guidance.
Relevant guidance.
Relevant guidance.
Relevant guidance.
Relevant guidance.
Relevant guidance.
Reaffirmation.
Withdrawn and replaced with
newer version.
Withdrawn and replaced with
newer version including amendment.
Withdrawn and replaced with
newer version including amendment.
Relevant guidance.
Relevant guidance.
Relevant guidance.
standard titles in this table conform to the style requirements of the respective organizations.
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: 038.
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS
Title of standard 1
Recognition No.
Reference No. and date
A. Anesthesia
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1–102 .................
Medical electrical equipment—Part 2–69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment.
ISO 80601–2–69 First edition 2014–07–15.
B. Cardiovascular
3–133 .................
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International Standard-Cardiovascular implants—Cardiac
valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques.
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TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Title of standard 1
Recognition No.
Reference No. and date
C. Dental/Ear, Nose, and Throat
4–218 .................
4–219 .................
International Standard–Dentistry—Brackets and tubes for use
in orthodontics.
International Standard–Dentistry–Adhesive–Notched Edge
Sheer Bond Strength Test.
ISO 27020 First edition 2010–12–15.
ISO 29022 First edition 2013–06–01.
D. General Hospital/General Plastic Surgery
6–338 .................
6–339 .................
6–340 .................
Standard Specification for Radiation Attenuating Protective
Gloves.
Standard Consumer Safety Specification for Full-Size Baby
Cribs.
Standard Consumer Safety Performance Specification for
Commercial Cribs.
ASTM D7866–14a.
ASTM F1169–13.
ASTM F2710–13.
E. Nanotechnology
18–3 ...................
Technical Specification—Surface characterization of gold
nanoparticles for nanomaterial specific toxicity screening:
FT–IR method.
ISO/TS 14101 First edition 2012–11–01.
F. Neurology
17–13 .................
IEEE Recommended Practice for Neurofeedback Systems ...
IEEE Std 2010–2012.
G. Ophthalmics
10–92 .................
10–93 .................
American National Standard for Ophthalmics-Contact
Lenses—Standard Terminology, Tolerances, Measurements and Physicochemical Properties.
American National Standard for Ophthalmics-Implantable
Glaucoma Devices.
ANSI Z80.20–2010 (Revision of ANSI Z80.20–2004) 12/06/
2010.
ANSI Z80.27–2014 (revision of ANSI Z80.27–2001 (R2011))
01/27/2014.
H. Orthopedic
11–285 ...............
11–286 ...............
Guide to Optimize Scan Sequences for Clinical Diagnostic
Evaluation of Metal-on-Metal Hip Arthroplasty Devices
using Magnetic Resonance Imaging.
Guide For the Characterization of Wear from the Articulating
Surfaces in Retrieved Metal-on-Metal and other Hard-onHard Prostheses.
ASTM F2978–13.
ASTM F2979–14.
I. Radiology
12–286 ...............
12–287 ...............
12–288 ...............
X-ray Equipment for Interventional Procedures—User Quality
Control Mode.
Supplemental Requirements for User Information and System Function Related to Dose in CT.
Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images (MRI).
NEMA XR–27–2013 with Amendment 1.
NEMA XR 28–2013.
NEMA MS 9–2008.
J. Software/Informatics
13–70 .................
13–71 .................
13–72 .................
Application of risk management for IT-networks incorporating
medical devices—Part 2–5: Application guidance—Guidance on distributed alarm systems.
Logical Observation Identifiers Names and Codes (LOINC) ...
Health informatics—Personal health device communication,
Part 10425: Device Specialization—Continuous Glucose
Monitor (CGM).
IEC TR 80001–2–5 2014.
LOINC 2.48 2014–06–27.
IEEE Std 11073–10425–2014.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
K. Sterility
14–456 ...............
1 All
Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607–1 and ISO 11607–2.
ISO/TS 16775 First edition 2014–05–15.
standard titles in this table conform to the style requirements of the respective organizations.
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Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices
IV. List of Recognized Standards
FDA maintains the Agency’s current
list of FDA Recognized Consensus
Standards in a searchable database that
may be accessed directly at FDA’s
Internet site at https://
www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.cfm. FDA
will incorporate the modifications and
revisions described in this notice into
the database and, upon publication in
the Federal Register, this recognition of
consensus standards will be effective.
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 Recognition List 033,
FDA no longer announces minor
revisions to the list of recognized
consensus standards such as technical
contact person, devices affected,
processes affected, Code of Federal
Regulations citations, and product
codes.
announcing ‘‘Modification to the List of
Recognized Standards, Recognition List
Number: 038’’ will be available at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm. You may
access ‘‘Guidance on the Recognition
and Use of Consensus Standards,’’ and
the searchable database for ‘‘FDA
Recognized Consensus Standards’’ at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards.
VII. Submission of Comments and
Effective Date
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
V. Recommendation of Standards for
will be posted to the docket at https://
Recognition by FDA
www.regulations.gov. FDA will consider
Any person may recommend
any comments received in determining
consensus standards as candidates for
whether to amend the current listing of
recognition under section 514 of the
modifications to the list of recognized
FD&C Act by submitting such
standards, Recognition List Number:
recommendations, with reasons for the
038. These modifications to the list of
recommendation to standards@
recognized standards are effective upon
cdrh.fda.gov. To be properly considered, publication of this notice in the Federal
such recommendations should contain,
Register.
at a minimum, the following
Dated: January 22, 2015.
information: (1) Title of the standard, (2)
Leslie Kux,
any reference number and date, (3)
Associate Commissioner for Policy.
name and address of the national or
[FR Doc. 2015–01420 Filed 1–26–15; 8:45 am]
international standards development
BILLING CODE 4164–01–P
organization, (4) a proposed list of
devices for which a declaration of
conformity to this standard should
DEPARTMENT OF HEALTH AND
routinely apply, and (5) a brief
HUMAN SERVICES
identification of the testing or
Food and Drug Administration
VI. Electronic Access
asabaliauskas on DSK5VPTVN1PROD with NOTICES
performance or other characteristics of
the device(s) that would be addressed
by a declaration of conformity.
Current Good Manufacturing Practice
Requirements for Combination
Products; Draft Guidance for Industry
and Food and Drug Administration
Staff; Availability
You may obtain a copy of ‘‘Guidance
on the Recognition and Use of
Consensus Standards’’ by using the
Internet. The Center for Devices and
Radiological Health (CDRH) maintains a
site on the Internet for easy access to
information including text, graphics,
and files that you may download to a
personal computer with access to the
Internet. Updated on a regular basis, the
CDRH home page, https://www.fda.gov/
MedicalDevices, includes a link to
standards-related documents including
the guidance and the current list of
recognized standards. After publication
in the Federal Register, this notice
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AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry and FDA staff entitled ‘‘Current
Good Manufacturing Practice
Requirements for Combination
Products.’’ The guidance describes and
explains the final rule on current good
SUMMARY:
PO 00000
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manufacturing practice (CGMP)
requirements for combination products,
including presenting general
considerations for CGMP compliance as
well as analysis of hypothetical
scenarios.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by March 30,
2015.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Current Good
Manufacturing Practice Requirements
for Combination Products’’ to the Office
of Combination Products, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5129,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: John
Barlow Weiner, Office of Combination
Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5129, Silver Spring,
MD 20993–0002, 301–796–8930.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry and FDA
staff entitled ‘‘Current Good
Manufacturing Practice Requirements
for Combination Products.’’ The
guidance provides background on
combination products, including an
overview of the final rule on CGMP
requirements for combination products
(78 FR 4307, January 22, 2013) (21 CFR
part 4) and the role of the lead center
and other Agency components with
respect to combination product CGMP
issues. The guidance addresses general
considerations for CGMP requirements
for combination products and the
purpose and content of specific CGMP
provisions addressed in part 4. The
guidance also contains hypothetical
scenarios intended to clarify how to
E:\FR\FM\27JAN1.SGM
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Agencies
[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4274-4280]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01420]
-----------------------------------------------------------------------
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: 038
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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: 038'' (Recognition List Number: 038), 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 concerning this
document at any time. See section VII of this document for the
effective date of the recognition of standards announced in this
document.
ADDRESSES: An electronic copy of Recognition List Number: 038 is
available on the Internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of
this document for electronic access to the searchable database for the
current list of FDA recognized consensus standards, including
Recognition List Number: 038 modifications and other standards related
information.
Submit written requests for a single copy of the document entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 038'' to the Division of Industry and Consumer Education,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request, or fax your request to 301-847-
8149.
Submit electronic comments on this document to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring,
[[Page 4275]]
MD 20993, 301-796-6287, standards@cdrh.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the 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 a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of a guidance entitled
``Recognition and Use of Consensus Standards.'' The notice described
how FDA would implement its standard recognition program and provided
the initial list of recognized standards.
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. Both versions are
publicly accessible at the Agency's Internet site. See section VI for
electronic access information. Interested persons should review the
supplementary information sheet for the standard to understand fully
the extent to which FDA recognizes the standard.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 038
FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency will recognize for
use in premarket submissions and other requirements for devices. FDA
will incorporate these modifications in the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA will use
the term ``Recognition List Number: 038'' to identify these 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 No. Title of standard \1\ Change
----------------------------------------------------------------------------------------------------------------
A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-57............................ ................ ASTM F1101-90 (Reapproved 2003) Withdrawn.
Standard Specification for
Ventilators Intended for Use
During Anesthesia.
1-69............................ ................ ASTM F1464-93 (Reapproved 2005) Withdrawn.
Standard Specification for
Oxygen Concentrators for
Domiciliary Use.
1-70............................ ................ ASTM F1246-91 (Reapproved 2005) Withdrawn.
Standard Specification for
Electrically Powered Home Care
Ventilators--Part 1: Positive-
Pressure Ventilators and
Ventilator Circuits.
1-94............................ ................ ISO 8359 Second edition 1996-12- Withdrawn. See 1-102.
15, Oxygen concentrators for
medical use--safety
requirements [including
amendment 1 (2012)].
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-143........................... 2-213 ASTM F1904-14 Standard Practice Withdrawn and replaced
for the Biological Responses to with newer version.
Particles in vivo.
2-144........................... 2-214 ASTM F619-14 Standard Practice Withdrawn and replaced
for Extraction of Medical with newer version.
Plastics.
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-88............................ ................ ASTM F2514-08 (Reapproved 2014) Reaffirmation.
Standard Guide for Finite
Element Analysis (FEA) of
Metallic Vascular Stents
Subjected to Uniform Radial
Loading.
3-123........................... ................ IEC 80601-2-30 Edition 1.1 2013- Extent of recognition and
07, Medical electrical Process impacted.
equipment--Part 2-30:
Particular requirements for the
basic safety and essential
performance of automated non-
invasive sphygmomanometers.
----------------------------------------------------------------------------------------------------------------
D. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-117........................... ................ ANSI/ADA Specification No. 12: Withdrawn.
2002 (Reaffirmed 2008) Denture
base polymers.
4-134........................... 4-213 ISO 7494-1 Second edition 2011- Withdrawn and replaced
08-15 Dentistry--Dental units-- with newer version.
Part 1: General requirements
and test methods.
4-135........................... 4-214 ISO 10139-1 Second edition 2005- Withdrawn and replaced
02-15, Dentistry--Soft lining with newer version
materials for removable including technical
dentures--Part 1: Materials for corrigendum.
short-term use [Including:
Technical Corrigendum 1 (2006)].
4-136........................... ................ ASTM F2504-05 (Reapproved 2014) Reaffirmation.
Standard Practice for
Describing System Output of
Implantable Middle Ear Hearing
Devices.
[[Page 4276]]
4-143........................... 4-215 ANSI/ADA Standard No. 96: 2012 Withdrawn and replaced
Dental Water-based Cements. with newer version.
4-159........................... 4-216 ANSI/IEEE ANSI C63.19-2011 Withdrawn and replaced
American National Standard with newer version.
Methods of Measurement of
Compatibility between Wireless
Communications Devices and
Hearing Aids.
4-170........................... 4-217 ANSI/ASA S3.36-2012 American Withdrawn and replaced
National Standard Specification with newer version.
for a Manikin for Simulated in-
situ Airborne Acoustic
Measurements.
4-183........................... ................ ANSI/ASA S3.2-2009 (Reaffirmed Reaffirmation.
2014) American National
Standard Method for Measuring
the Intelligibility of Speech
over Communication Systems.
4-185........................... ................ ANSI/ASA S3.45-2009 (Reaffirmed Reaffirmation.
2014) American National
Standard Procedures for Testing
Basic Vestibular Function.
----------------------------------------------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management (QS/RM))
----------------------------------------------------------------------------------------------------------------
5-48............................ ................ ANSI/ASQ Z1.9-2003 (R2013) Reaffirmation.
Sampling Procedures and Tables
for Inspection by Variables for
Percent Nonconforming.
5-57............................ ................ ANSI/AAMI HE75:2009/(R)2013 Reaffirmation.
Human factors engineering--
Design of medical devices.
5-62............................ ................ ANSI/ASQ Z1.4-2003 (R2013) Reaffirmation.
Sampling Procedures and Tables
for Inspection by Attributes.
----------------------------------------------------------------------------------------------------------------
F. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-199........................... 6-335 ASTM F2101-14 Standard Test Withdrawn and replaced
Method for Evaluating the with newer version.
Bacterial Filtration Efficiency
(BFE) of Medical Face Mask
Materials, Using a Biological
Aerosol of Staphylococcus
aureus.
6-217........................... ................ ASTM F1670/F1670M-08 (Reapproved Reaffirmation.
2014)\[epsiv]1\ Standard Test
Method for Resistance of
Materials Used in Protective
Clothing to Penetration by
Synthetic Blood.
6-228........................... 6-336 IEC 60601-2-2 Edition 5.0 2009- Withdrawn and replaced
02 Medical Electrical with newer version
Equipment--Part 2-2: Particular including technical
Requirements for the Basic corrigendum.
Safety and Essential
Performance of High Frequency
Surgical Equipment and High
Frequency Surgical Accessories
[Including: Technical
Corrigendum 1 (2014)].
6-231........................... 6-337 ANSI/AAMI/IEC 60601-2-20:2009 Withdrawn and replaced
Medical Electrical Equipment-- with newer version
Part 2-20: Particular including erratum.
Requirements for the Basic
Safety and Essential
Performance of Infant Transport
Incubators [Including: Erratum
(2012)].
----------------------------------------------------------------------------------------------------------------
G. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-84............................ ................ CEN 13640, Stability Testing of Withdrawn.
In Vitro Diagnostic Reagents.
7-162........................... ................ CLSI POCT14-A (Formerly H49-A) Withdrawn duplicate. See 7-
Point-Of-Care Monitoring of 112.
Anticoagulation Therapy;
Approved Guideline.
7-184........................... 7-250 CLSI M40-A2 Quality Control of Withdrawn and replaced
Microbiological Transport with newer version.
Systems; Approved Standard--
Second Edition.
----------------------------------------------------------------------------------------------------------------
H. Materials
----------------------------------------------------------------------------------------------------------------
8-111........................... 8-380 ASTM F1160-14 Standard Test Withdrawn and replaced
Method for Shear and Bending with newer version.
Fatigue Testing of Calcium
Phosphate and Metallic Medical
and Composite Calcium Phosphate/
Metallic Coatings.
8-124........................... 8-381 ASTM F2052-14 Standard Test Withdrawn and replaced
Method for Measurement of with newer version.
Magnetically Induced
Displacement Force on Medical
Devices in the Magnetic
Resonance Environment.
8-171........................... ................ ASTM F1609-08 (Reapproved 2014) Reaffirmation.
Standard Specification for
Calcium Phosphate Coatings for
Implantable Materials.
8-198........................... 8-382 ASTM F2102-13 Standard Guide for Withdrawn and replaced
Evaluating the Extent of with newer version.
Oxidation in Polyethylene
Fabricated Forms Intended for
Surgical Implants.
8-207........................... 8-383 ASTM F1926/F1926M-14 Standard Withdrawn and replaced
Test Method for Dissolution with newer version.
Testing of Calcium Phosphate
Granules, Fabricated Forms, and
Coatings.
8-340........................... 8-384 ASTM F2026-14 Standard Withdrawn and replaced
Specification for with newer version.
Polyetheretherketone (PEEK)
Polymers for Surgical Implant
Applications.
8-357........................... 8-385 ASTM F648-14 Standard Withdrawn and replaced
Specification for Ultra-High- with newer version.
Molecular-Weight Polyethylene
Powder and Fabricated Form for
Surgical Implants.
----------------------------------------------------------------------------------------------------------------
[[Page 4277]]
I. OB-GYN/Gastroenterology/Urology
----------------------------------------------------------------------------------------------------------------
9-6............................. 9-95 IEC 60601-2-36 Edition 2.0 2014- Withdrawn and replaced
04 Medical electrical with newer version.
equipment--Part 2-36:
Particular requirements for the
basic safety and essential
performance of equipment for
extracorporeally induced
lithotripsy.
9-45............................ ................ ASTM F2528-06 (Reapproved 2014) Reaffirmation.
Standard Test Methods for
Enteral Feeding Devices with a
Retention Balloon.
9-62............................ 9-96 IEC 60601-2-2 Edition 5.0 2009- Withdrawn and replaced
02 Medical Electrical with newer version
Equipment--Part 2-2: Particular including technical
Requirements for the Basic corrigendum.
Safety and Essential
Performance of High Frequency
Surgical Equipment and High
Frequency Surgical Accessories
[Including: Technical
Corrigendum 1 (2014)].
9-74............................ 9-97 ISO 13958 Third edition 2014-04- Withdrawn and replaced
01 Concentrates for with newer version.
haemodialysis and related
therapies.
9-76............................ 9-98 ISO 13959 Third edition 2014-04- Withdrawn and replaced
01 Water for haemodialysis and with newer version.
related therapies.
9-77............................ 9-99 ISO 23500 Second edition 2014-04- Withdrawn and replaced
01 Guidance for the preparation with newer version.
and quality management of
fluids for haemodialysis and
related therapies.
9-78............................ 9-100 ISO 11663 Second edition 2014-04- Withdrawn and replaced
01 Quality of dialysis fluid with a newer version.
for haemodialysis and related
therapies.
9-79............................ 9-101 ISO 26722 Second edition 2014-04- Withdrawn and replaced
01 Water treatment equipment with a newer version.
for haemodialysis applications
and related therapies.
9-82............................ 9-102 ISO 4074 Second edition 2014-08- Withdrawn and replaced
15 Natural rubber latex male with newer version.
condoms--Requirements and test
methods.
----------------------------------------------------------------------------------------------------------------
J. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-49........................... 10-90 ISO 11979-9 First edition 2006- Withdrawn and replaced
09-01 Ophthalmic implants-- with newer version
Intraocular lenses--Part 9: including amendment.
Multifocal intraocular lenses
[Including: Amendment 1(2014)].
10-50........................... 10-91 ISO 11979-10 First edition 2006- Withdrawn and replaced
08-15 Ophthalmic implants-- with newer version
Intraocular lenses--Part 10: including amendment.
Phakic intraocular lenses
[Including: Amendment 1 (2014)].
10-80........................... ................ ISO 18369-2 Second edition 2012- Extent of recognition and
12-01 Ophthalmic optics-- relevant guidance.
Contact lenses--Part 2:
Tolerances.
----------------------------------------------------------------------------------------------------------------
K. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-196.......................... 11-281 ASTM F1672-14 Standard Withdrawn and replaced
Specification for Resurfacing newer version.
Patellar Prosthesis.
11-213.......................... 11-282 ASTM F1223-14 Standard Test Withdrawn and replaced
Method for Determination of with newer version.
Total Knee Replacement
Constraint.
11-260.......................... 11-283 ASTM F2943-14 Standard Guide for Withdrawn and replaced
Presentation of End User with newer version.
Labeling Information for
Musculoskeletal Implants.
11-263.......................... 11-284 ASTM F2028-14 Standard Test Withdrawn and replaced
Methods for Dynamic Evaluation with newer version.
of Glenoid Loosening or
Disassociation.
----------------------------------------------------------------------------------------------------------------
L. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-189.......................... 16-193 ASME A18.1-2014 Safety Standard Withdrawn and replaced
for Platform Lifts and Stairway with newer version.
Chairlifts.
----------------------------------------------------------------------------------------------------------------
M. Radiology
----------------------------------------------------------------------------------------------------------------
12-181.......................... 12-284 NEMA NU 1-2012 Performance Withdrawn and replaced
Measurements of Gamma Cameras. with newer version.
12-206.......................... 12-285 IEC 60601-2-1 Edition 3.1 2014- Withdrawn and replaced
07 Medical electrical with newer version.
equipment--Part 2-1: Particular
requirements for the basic
safety and essential
performance of electron
accelerators in the range 1 MeV
to 50 MeV.
12-230.......................... ................ NEMA XR 24-2008 (R2014) Primary Reaffirmation.
User Controls for
Interventional Angiography X-
Ray Equipment.
----------------------------------------------------------------------------------------------------------------
N. Sterility
----------------------------------------------------------------------------------------------------------------
14-139.......................... ................ ISO 14644-1 First edition 1999- Relevant guidance.
05-01 Cleanrooms and associated
controlled environments--Part
1: Classification of air
cleanliness.
[[Page 4278]]
14-140.......................... ................ ISO 14644-2 First edition 2000- Relevant guidance.
09-15 Cleanrooms and associated
controlled environments--Part
2: Specifications for testing
and monitoring to prove
continued compliance with ISO
14644-1.
14-141.......................... ................ ISO 14644-4 First edition 2001- Relevant guidance.
04-01 Cleanrooms and associated
controlled environments--Part
4: Design, construction and
start-up.
14-165.......................... ................ ISO 14644-5 First edition 2004- Relevant guidance.
08-15 Cleanrooms and associated
controlled environments--Part
5: Operations.
14-166.......................... ................ ISO 14644-7 First edition 2004- Relevant guidance.
10-01 Cleanrooms and associated
controlled environments--Part
7: Separative devices (clean
air hoods, gloveboxes,
isolators and mini-
environments).
14-193.......................... ................ ANSI/AAMI/ISO 11607-1:2006/ Relevant guidance.
(R)2010, Packaging for
terminally sterilized medical
devices--Part 1: Requirements
for materials, sterile barrier
systems, and packaging systems.
14-194.......................... ................ ANSI/AAMI/ISO 11607-2:2006/ Relevant guidance.
(R)2010, Packaging for
terminally sterilized medical
devices--Part 2: Validation
requirements for forming,
sealing and assembly processes.
14-238.......................... ................ AAMI/ANSI/ISO 11140-5:2007/ Relevant guidance.
(R)2012, Sterilization of
health care products--Chemical
indicators--Part 5: Class 2
indicators for Bowie and Dick
air removal test sheets and
packs.
14-242.......................... ................ ISO 14644-3 First edition 2005- Relevant guidance.
12-15 Cleanrooms and associated
controlled environments--Part
3: Test methods.
14-243.......................... ................ ISO 14644-6 First edition Relevant guidance.
Cleanrooms and associated
controlled environments--Part
6: Vocabulary.
14-274.......................... ................ ANSI/AAMI/ISO 15882:2008/ Reaffirmation.
(R)2013, Sterilization of
health care products--Chemical
indicators--Guidance for
selection, use and
interpretation of results.
14-299.......................... 14-453 ASTM F2097-14 Standard Guide for Withdrawn and replaced
Design and Evaluation of with newer version.
Primary Flexible Packaging for
Medical Products.
14-355.......................... 14-454 ISO 11607-1 First edition 2006- Withdrawn and replaced
04-15 Packaging for terminally with newer version
sterilized medical devices-- including amendment.
Part 1: Requirements for
materials, sterile barrier
systems and packaging systems
[Including: Amendment 1 (2014)].
14-356.......................... 14-455 ISO 11607-2 First edition 2006- Withdrawn and replaced
04-15 Packaging for terminally with newer version
sterilized medical devices-- including amendment.
Part 2: Validation requirements
for forming, sealing and
assembly processes [Including:
Amendment 1 (2014)].
14-379.......................... ................ ISO 14644-8 Second edition 2013- Relevant guidance.
02-15 Cleanrooms and associated
controlled environments--Part
8: Classification of air
cleanliness by chemical
concentration (ACC).
14-389.......................... ................ ISO 14644-9 First edition 2012- Relevant guidance.
08-15 Cleanrooms and associated
controlled environments--Part
9: Classification of surface
cleanliness by particle
concentration.
14-390.......................... ................ ISO 14644-10 First edition 2013- Relevant guidance.
03-01 Cleanrooms and associated
controlled environments--Part
10: Classification of surface
cleanliness by chemical
concentration.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.
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: 038.
Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Recognition No. Title of standard \1\ Reference No. and date
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
1-102.................. Medical electrical ISO 80601-2-69 First
equipment--Part 2-69: edition 2014-07-15.
Particular
requirements for basic
safety and essential
performance of oxygen
concentrator equipment.
------------------------------------------------------------------------
B. Cardiovascular
------------------------------------------------------------------------
3-133.................. International Standard- ISO 5840-3 First
Cardiovascular edition 2013-03-01.
implants--Cardiac
valve prostheses--Part
3: Heart valve
substitutes implanted
by transcatheter
techniques.
------------------------------------------------------------------------
[[Page 4279]]
C. Dental/Ear, Nose, and Throat
------------------------------------------------------------------------
4-218.................. International Standard- ISO 27020 First
Dentistry--Brackets edition 2010-12-15.
and tubes for use in
orthodontics.
4-219.................. International Standard- ISO 29022 First
Dentistry-Adhesive-Not edition 2013-06-01.
ched Edge Sheer Bond
Strength Test.
------------------------------------------------------------------------
D. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
6-338.................. Standard Specification ASTM D7866-14a.
for Radiation
Attenuating Protective
Gloves.
6-339.................. Standard Consumer ASTM F1169-13.
Safety Specification
for Full-Size Baby
Cribs.
6-340.................. Standard Consumer ASTM F2710-13.
Safety Performance
Specification for
Commercial Cribs.
------------------------------------------------------------------------
E. Nanotechnology
------------------------------------------------------------------------
18-3................... Technical ISO/TS 14101 First
Specification--Surface edition 2012-11-01.
characterization of
gold nanoparticles for
nanomaterial specific
toxicity screening: FT-
IR method.
------------------------------------------------------------------------
F. Neurology
------------------------------------------------------------------------
17-13.................. IEEE Recommended IEEE Std 2010-2012.
Practice for
Neurofeedback Systems.
------------------------------------------------------------------------
G. Ophthalmics
------------------------------------------------------------------------
10-92.................. American National ANSI Z80.20-2010
Standard for (Revision of ANSI
Ophthalmics-Contact Z80.20-2004) 12/06/
Lenses--Standard 2010.
Terminology,
Tolerances,
Measurements and
Physicochemical
Properties.
10-93.................. American National ANSI Z80.27-2014
Standard for (revision of ANSI
Ophthalmics- Z80.27-2001 (R2011))
Implantable Glaucoma 01/27/2014.
Devices.
------------------------------------------------------------------------
H. Orthopedic
------------------------------------------------------------------------
11-285................. Guide to Optimize Scan ASTM F2978-13.
Sequences for Clinical
Diagnostic Evaluation
of Metal-on-Metal Hip
Arthroplasty Devices
using Magnetic
Resonance Imaging.
11-286................. Guide For the ASTM F2979-14.
Characterization of
Wear from the
Articulating Surfaces
in Retrieved Metal-on-
Metal and other Hard-
on-Hard Prostheses.
------------------------------------------------------------------------
I. Radiology
------------------------------------------------------------------------
12-286................. X-ray Equipment for NEMA XR-27-2013 with
Interventional Amendment 1.
Procedures--User
Quality Control Mode.
12-287................. Supplemental NEMA XR 28-2013.
Requirements for User
Information and System
Function Related to
Dose in CT.
12-288................. Characterization of NEMA MS 9-2008.
Phased Array Coils for
Diagnostic Magnetic
Resonance Images (MRI).
------------------------------------------------------------------------
J. Software/Informatics
------------------------------------------------------------------------
13-70.................. Application of risk IEC TR 80001-2-5 2014.
management for IT-
networks incorporating
medical devices--Part
2-5: Application
guidance--Guidance on
distributed alarm
systems.
13-71.................. Logical Observation LOINC 2.48 2014-06-27.
Identifiers Names and
Codes (LOINC).
13-72.................. Health informatics-- IEEE Std 11073-10425-
Personal health device 2014.
communication, Part
10425: Device
Specialization--Contin
uous Glucose Monitor
(CGM).
------------------------------------------------------------------------
K. Sterility
------------------------------------------------------------------------
14-456................. Packaging for ISO/TS 16775 First
terminally sterilized edition 2014-05-15.
medical devices--
Guidance on the
application of ISO
11607-1 and ISO 11607-
2.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.
[[Page 4280]]
IV. List of Recognized Standards
FDA maintains the Agency's current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed directly at
FDA's Internet site at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications
and revisions described in this notice into the database and, upon
publication in the Federal Register, this recognition of consensus
standards will be effective. 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 Recognition List 033, FDA no longer announces minor
revisions to the list of recognized consensus standards such as
technical contact person, devices affected, processes affected, Code of
Federal Regulations citations, and product codes.
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
standards@cdrh.fda.gov. To be properly considered, such recommendations
should contain, at a minimum, the following information: (1) Title of
the standard, (2) any reference number and date, (3) name and address
of the national or international standards development organization,
(4) a proposed list of devices for which a declaration of conformity to
this standard should routinely apply, and (5) a brief identification of
the testing or performance or other characteristics of the device(s)
that would be addressed by a declaration of conformity.
VI. Electronic Access
You may obtain a copy of ``Guidance on the Recognition and Use of
Consensus Standards'' by using the Internet. The Center for Devices and
Radiological Health (CDRH) maintains a site on the Internet for easy
access to information including text, graphics, and files that you may
download to a personal computer with access to the Internet. Updated on
a regular basis, the CDRH home page, https://www.fda.gov/MedicalDevices,
includes a link to standards-related documents including the guidance
and the current list of recognized standards. After publication in the
Federal Register, this notice announcing ``Modification to the List of
Recognized Standards, Recognition List Number: 038'' will be available
at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. You may access ``Guidance on the Recognition
and Use of Consensus Standards,'' and the searchable database for ``FDA
Recognized Consensus Standards'' at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.
VII. Submission of Comments and Effective Date
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. 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: 038. These
modifications to the list of recognized standards are effective upon
publication of this notice in the Federal Register.
Dated: January 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01420 Filed 1-26-15; 8:45 am]
BILLING CODE 4164-01-P