Safety and Performance Based Pathway Device-Specific Guidance; Draft Guidances for Industry and Food and Drug Administration Staff; Availability, 49528-49530 [2019-20370]

Download as PDF 49528 Federal Register / Vol. 84, No. 183 / Friday, September 20, 2019 / Notices malfunctions; and (2) user facilities to report device-related deaths directly to manufacturers and FDA and serious injuries to the manufacturer. Section 213 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105–115) amended section 519(b) of the FD&C Act relating to mandatory reporting by user facilities of deaths, serious injuries, and serious illnesses associated with the use of medical devices. This amendment legislated the replacement of universal user facility reporting by a system that is limited to a ‘‘. . . subset of user facilities that constitutes a representative profile of user reports’’ for device-related deaths and serious injuries. This amendment is reflected in section 519(b)(5)(A) of the FD&C Act. This legislation provides FDA with the opportunity to design and implement a national surveillance network, composed of well-trained clinical facilities, to provide high-quality data on medical devices in clinical use. This system is called the Medical Product Safety Network (MedSun). FDA is seeking OMB clearance to continue to use electronic data collection to obtain the information on Form FDA 3500A (approved under OMB control number 0910–0291) related to medical devices and tissue products from the user facilities participating in MedSun, to obtain a demographic profile of the facilities, and for additional questions, which will permit FDA to better understand the cause of reported adverse events. Participation in the program is voluntary and includes approximately 300 facilities. In addition to collecting data on the electronic adverse event report form, MedSun collects additional information from participating sites about reported problems emerging from the MedSun hospitals. This data collection is also voluntary and is collected on the same website as the report information. The burden estimate is based on the number of facilities participating in MedSun (300). FDA estimates an average of 18 reports per site annually. This estimate is based on MedSun working to promote reporting in general from the sites, as well as promoting reporting from specific parts of the hospitals, such as the pediatric intensive care units, the electrophysiology laboratories, and the hospital laboratories. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Adverse event reporting ...................................... 300 18 5,400 0.50 (30 minutes) ........... 2,700 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Our estimated burden for the information collection reflects an overall decrease of 113 hours despite a corresponding increase of 1,650 responses. We attribute this adjustment to an increase in the number of submissions we received over the last few years but a decrease in the amount of time spent entering data due to IT efficiencies that have been built into the MedSun reporting system to reduce data entry by user facilities. Dated: September 6, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–20355 Filed 9–19–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration khammond on DSKJM1Z7X2PROD with NOTICES [Docket Nos. FDA–2019–D–1647, FDA– 2019–D–1649, FDA–2019–D–1651, and FDA– 2019–D–1652] Safety and Performance Based Pathway Device-Specific Guidance; Draft Guidances for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 17:13 Sep 19, 2019 Jkt 247001 ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of several device-specific draft guidance documents for the Safety and Performance Based Pathway— specifically, ‘‘Spinal Plating Systems— Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff’’; ‘‘Cutaneous Electrode for Recording Purposes— Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff’’; ‘‘Conventional Foley Catheters— Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff’’; and ‘‘Orthopedic Non-Spinal Metallic Bone Screws and Washers—Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff.’’ The devicespecific draft guidances identified in this notice were developed in accordance with the finalized guidance entitled ‘‘Safety and Performance Based Pathway.’’ These draft guidances are not final nor are they in effect at this time. SUMMARY: PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 Submit either electronic or written comments on the draft guidances by December 19, 2019 to ensure that the Agency considers your comment on these draft guidance documents before it begins work on the final version of the guidance documents. DATES: You may submit comments on any guidance at any time as follows: ADDRESSES: 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. E:\FR\FM\20SEN1.SGM 20SEN1 Federal Register / Vol. 84, No. 183 / Friday, September 20, 2019 / Notices khammond on DSKJM1Z7X2PROD with NOTICES • 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 Docket No. FDA–2019–D– 1647 for ‘‘Spinal Plating Systems— Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff’’; Docket No. FDA–2019–D–1649 for ‘‘Cutaneous Electrode for Recording Purposes— Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff’’; Docket No. FDA–2019–D–1651 for ‘‘Conventional Foley Catheters—Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff’’; and Docket No. FDA–2019–D– 1652 for ‘‘Orthopedic Non-Spinal Metallic Bone Screws and Washers— Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff.’’ Received comments will be placed in the dockets 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. • 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 VerDate Sep<11>2014 17:13 Sep 19, 2019 Jkt 247001 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). An electronic copy of the guidances are available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidances. Submit written requests for a single hard copy of the draft guidances entitled ‘‘Spinal Plating Systems—Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff,’’ ‘‘Cutaneous Electrode for Recording Purposes— Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff,’’ ‘‘Conventional Foley Catheters— Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff,’’ or ‘‘Orthopedic Non-Spinal Metallic Bone Screws and Washers—Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff’’ to the Office of Policy, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 49529 MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Jason Ryans, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993–0002, 301–796–4908. SUPPLEMENTARY INFORMATION: I. Background These device-specific draft guidances provide performance criteria for premarket notification (510k) submissions to support the optional Safety and Performance Based Pathway, as described in the guidance entitled ‘‘Safety and Performance Based Pathway.’’ 1 As described in that guidance, substantial equivalence is rooted in comparisons between new devices and predicate devices. However, the Federal Food, Drug, and Cosmetic Act does not preclude FDA from using performance criteria to facilitate this comparison. If a legally marketed device performs at certain levels relevant to its safety and effectiveness, and a new device meets those levels of performance for the same characteristics, FDA could find the new device as safe and effective as the legally marketed device. Instead of reviewing data from direct comparison testing between the two devices, FDA could support a finding of substantial equivalence with data demonstrating the new device meets the level of performance of an appropriate predicate device(s). Under this optional Safety and Performance Based Pathway, a submitter could satisfy the requirement to compare its device with a legally marketed device by, among other things, independently demonstrating that the device’s performance meets performance criteria as established in the above-listed guidances, when finalized, rather than using direct predicate comparison testing for some of the performance characteristics. II. Significance of Guidance These draft guidances are being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). These draft guidances, when finalized, will represent the current thinking of FDA on performance criteria for the ‘‘Safety and Performance Based Pathway for Spinal Plating Systems,’’ ‘‘Cutaneous Electrode for Recording Purposes,’’ ‘‘Conventional Foley Catheters,’’ and ‘‘Orthopedic Non1 Available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/ safety-and-performance-based-pathway. E:\FR\FM\20SEN1.SGM 20SEN1 49530 Federal Register / Vol. 84, No. 183 / Friday, September 20, 2019 / Notices Spinal Metallic Bone Screws and Washers.’’ They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. These guidances are not subject to Executive Order 12866. III. Electronic Access Persons interested in obtaining a copy of the draft guidances may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. These draft guidances are also available at https://www.regulations.gov. Persons Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff (document number 19009)’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the documents. Please use the document number and complete title to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 These draft guidance documents refer to previously approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information have been approved by OMB as listed in the following table: 21 CFR part or guidance Topic 807, subpart E .............................................................................................................. ‘‘Requests for Feedback on Medical Device Submissions: The Q-Submission Program and Meetings with Food and Drug Administration Staff’’. Premarket Notification .............................. Q-Submissions .......................................... Dated: September 16, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–20370 Filed 9–19–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–3403] The Food and Drug Administration Solicits Input on Potential Role for Abuse-Deterrent Formulations of Central Nervous System Stimulants; Establishment of a Public Docket; Request for Comments AGENCY: Submit either electronic or written comments by November 19, 2019. Notice; establishment of a public docket; request for comments. ACTION: The Food and Drug Administration (FDA) is establishing a public docket to receive comments from interested parties, including patients, patient advocates, healthcare providers, academics, researchers, the pharmaceutical industry, and other government entities, on considerations related to the development and evaluation of abuse-deterrent formulations (ADFs) of central nervous system stimulants and whether such products could play a role in addressing VerDate Sep<11>2014 17:13 Sep 19, 2019 Jkt 247001 FDA is establishing a docket for public comment. The docket number is FDA–2019–N–3403. The docket will close on November 19, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 19, 2019. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 19, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. You may submit comments as follows: ADDRESSES: Food and Drug Administration, SUMMARY: public health concerns related to prescription stimulant misuse and abuse. This notice provides an overview of available postmarket data on the use, misuse, and abuse of prescription stimulants and associated morbidity and mortality, along with similar data on prescription opioids to provide context; background information on the development and evaluation of ADF products; and specific questions on which FDA seeks input. The Appendix lists the sources used in developing this overview. DATES: HHS. khammond on DSKJM1Z7X2PROD with NOTICES unable to download an electronic copy of either ‘‘Spinal Plating Systems— Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff (document number 19008),’’ ‘‘Cutaneous Electrode for Recording Purposes—Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff (document number 19014),’’ ‘‘Conventional Foley Catheters—Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff (document number 19010),’’ or ‘‘Orthopedic Non-Spinal Metallic Bone Screws and Washers—Performance Criteria for Safety and Performance PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 OMB control No. 0910–0120 0910–0756 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 E:\FR\FM\20SEN1.SGM 20SEN1

Agencies

[Federal Register Volume 84, Number 183 (Friday, September 20, 2019)]
[Notices]
[Pages 49528-49530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20370]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-D-1647, FDA-2019-D-1649, FDA-2019-D-1651, and 
FDA-2019-D-1652]


Safety and Performance Based Pathway Device-Specific Guidance; 
Draft Guidances for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of several device-specific draft guidance documents 
for the Safety and Performance Based Pathway--specifically, ``Spinal 
Plating Systems--Performance Criteria for Safety and Performance Based 
Pathway; Draft Guidance for Industry and Food and Drug Administration 
Staff''; ``Cutaneous Electrode for Recording Purposes--Performance 
Criteria for Safety and Performance Based Pathway; Draft Guidance for 
Industry and Food and Drug Administration Staff''; ``Conventional Foley 
Catheters--Performance Criteria for Safety and Performance Based 
Pathway; Draft Guidance for Industry and Food and Drug Administration 
Staff''; and ``Orthopedic Non-Spinal Metallic Bone Screws and Washers--
Performance Criteria for Safety and Performance Based Pathway; Draft 
Guidance for Industry and Food and Drug Administration Staff.'' The 
device-specific draft guidances identified in this notice were 
developed in accordance with the finalized guidance entitled ``Safety 
and Performance Based Pathway.'' These draft guidances are not final 
nor are they in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidances by December 19, 2019 to ensure that the Agency considers your 
comment on these draft guidance documents before it begins work on the 
final version of the guidance documents.

ADDRESSES: You may submit comments on any guidance 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.

[[Page 49529]]

     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 Docket No. FDA-
2019-D-1647 for ``Spinal Plating Systems--Performance Criteria for 
Safety and Performance Based Pathway; Draft Guidance for Industry and 
Food and Drug Administration Staff''; Docket No. FDA-2019-D-1649 for 
``Cutaneous Electrode for Recording Purposes--Performance Criteria for 
Safety and Performance Based Pathway; Draft Guidance for Industry and 
Food and Drug Administration Staff''; Docket No. FDA-2019-D-1651 for 
``Conventional Foley Catheters--Performance Criteria for Safety and 
Performance Based Pathway; Draft Guidance for Industry and Food and 
Drug Administration Staff''; and Docket No. FDA-2019-D-1652 for 
``Orthopedic Non-Spinal Metallic Bone Screws and Washers--Performance 
Criteria for Safety and Performance Based Pathway; Draft Guidance for 
Industry and Food and Drug Administration Staff.'' Received comments 
will be placed in the dockets 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.
     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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidances are available for download from 
the internet. See the SUPPLEMENTARY INFORMATION section for information 
on electronic access to the guidances. Submit written requests for a 
single hard copy of the draft guidances entitled ``Spinal Plating 
Systems--Performance Criteria for Safety and Performance Based Pathway; 
Draft Guidance for Industry and Food and Drug Administration Staff,'' 
``Cutaneous Electrode for Recording Purposes--Performance Criteria for 
Safety and Performance Based Pathway; Draft Guidance for Industry and 
Food and Drug Administration Staff,'' ``Conventional Foley Catheters--
Performance Criteria for Safety and Performance Based Pathway; Draft 
Guidance for Industry and Food and Drug Administration Staff,'' or 
``Orthopedic Non-Spinal Metallic Bone Screws and Washers--Performance 
Criteria for Safety and Performance Based Pathway; Draft Guidance for 
Industry and Food and Drug Administration Staff'' to the Office of 
Policy, Guidance and Policy Development, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request.

FOR FURTHER INFORMATION CONTACT: Jason Ryans, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993-0002, 301-796-4908.

SUPPLEMENTARY INFORMATION:

I. Background

    These device-specific draft guidances provide performance criteria 
for premarket notification (510k) submissions to support the optional 
Safety and Performance Based Pathway, as described in the guidance 
entitled ``Safety and Performance Based Pathway.'' \1\ As described in 
that guidance, substantial equivalence is rooted in comparisons between 
new devices and predicate devices. However, the Federal Food, Drug, and 
Cosmetic Act does not preclude FDA from using performance criteria to 
facilitate this comparison. If a legally marketed device performs at 
certain levels relevant to its safety and effectiveness, and a new 
device meets those levels of performance for the same characteristics, 
FDA could find the new device as safe and effective as the legally 
marketed device. Instead of reviewing data from direct comparison 
testing between the two devices, FDA could support a finding of 
substantial equivalence with data demonstrating the new device meets 
the level of performance of an appropriate predicate device(s). Under 
this optional Safety and Performance Based Pathway, a submitter could 
satisfy the requirement to compare its device with a legally marketed 
device by, among other things, independently demonstrating that the 
device's performance meets performance criteria as established in the 
above-listed guidances, when finalized, rather than using direct 
predicate comparison testing for some of the performance 
characteristics.
---------------------------------------------------------------------------

    \1\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway.
---------------------------------------------------------------------------

II. Significance of Guidance

    These draft guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). These draft guidances, 
when finalized, will represent the current thinking of FDA on 
performance criteria for the ``Safety and Performance Based Pathway for 
Spinal Plating Systems,'' ``Cutaneous Electrode for Recording 
Purposes,'' ``Conventional Foley Catheters,'' and ``Orthopedic Non-

[[Page 49530]]

Spinal Metallic Bone Screws and Washers.'' They do not establish any 
rights for any person and are not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations. These guidances are not subject to 
Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidances may 
do so by downloading an electronic copy from the internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. These draft 
guidances are also available at https://www.regulations.gov. Persons 
unable to download an electronic copy of either ``Spinal Plating 
Systems--Performance Criteria for Safety and Performance Based Pathway; 
Draft Guidance for Industry and Food and Drug Administration Staff 
(document number 19008),'' ``Cutaneous Electrode for Recording 
Purposes--Performance Criteria for Safety and Performance Based 
Pathway; Draft Guidance for Industry and Food and Drug Administration 
Staff (document number 19014),'' ``Conventional Foley Catheters--
Performance Criteria for Safety and Performance Based Pathway; Draft 
Guidance for Industry and Food and Drug Administration Staff (document 
number 19010),'' or ``Orthopedic Non-Spinal Metallic Bone Screws and 
Washers--Performance Criteria for Safety and Performance Based Pathway; 
Draft Guidance for Industry and Food and Drug Administration Staff 
(document number 19009)'' may send an email request to [email protected] to receive an electronic copy of the documents. 
Please use the document number and complete title to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    These draft guidance documents refer to previously approved 
collections of information. These collections of information are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information have been approved by OMB as listed in the 
following table:

------------------------------------------------------------------------
                                                           OMB  control
      21 CFR part or guidance               Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     Notification.
``Requests for Feedback on Medical  Q-Submissions.......       0910-0756
 Device Submissions: The Q-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
------------------------------------------------------------------------


    Dated: September 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20370 Filed 9-19-19; 8:45 am]
 BILLING CODE 4164-01-P

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