2023-19283. Modernizing the Food and Drug Administration's Premarket Notification Program; 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 three draft guidances entitled “Evidentiary Expectations for 510(k) Implant Devices,” “Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions,” and “Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission.” FDA is issuing these guidances to improve the predictability, consistency, and transparency of the 510(k) premarket review process. The draft guidances are not final nor are they for implementation at this time.

DATES:

Submit either electronic or written comments on the draft guidance by December 6, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

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.

• 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–2023–D–3132 for “Evidentiary Expectations for 510(k) Implant Devices,” Docket No. FDA–2023–D–3133 for “Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions,” or Docket No. FDA–2023–D–3134 for “Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500.

• 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.govinfo.gov/​content/​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, 240–402–7500.

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled “Evidentiary Expectations for 510(k) Implant Devices,” “Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions,” or “Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission” to the Office of Policy, 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:

Angela DeMarco, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2436, Silver Spring, MD 20993–0002, 301–796–4471; or Anne Taylor, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7242, Silver Spring, MD 20993, 240–402–8113.

SUPPLEMENTARY INFORMATION:

I. Background

As part of FDA's Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health,^[1] FDA committed to strengthen and modernize the premarket notification (510(k)) Program. FDA is issuing these three draft guidances to enhance the transparency, consistency, and predictability of the 510(k) premarket review process.

In “Evidentiary Expectations for 510(k) Implant Devices,” FDA discusses considerations that are generally relevant to all types of implants subject to 510(k) requirements. This draft guidance is intended to serve as a primary resource, used in conjunction with other guidances, to provide clarity and facilitate discussions regarding expectations for performance data that may be necessary to establish substantial equivalence for implanted medical devices. However, the type and quantity of performance data needed to support a substantial equivalence determination for a particular device will vary depending on the device and/or device type and on the differences from the predicate device.

In “Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions,” FDA clarifies and provides additional context for situations when clinical data may be necessary to demonstrate substantial equivalence, as initially described in the final guidance “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” ^[2] (“510(k) Program Guidance”). This draft guidance expands on the scenarios described in the 510(k) Program Guidance, describes another scenario, and provides additional examples to illustrate when clinical data may or may not be necessary to include in a 510(k) submission to demonstrate substantial equivalence.

Finally, in “Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission,” FDA proposes four best practices for choosing a predicate device used to support a 510(k) submission. Initially, FDA considered making public on its website those cleared devices that demonstrated substantial equivalence to older predicate devices. FDA also considered focusing on predicates that were more than 10 years old as a starting point. FDA issued a public notice on its website that requested public comment on this proposal.^[3] After considering the docket comments, FDA believes use of best practices that encourage the use of predicate devices with certain characteristics, rather than focusing on the age of the predicate, will support modernization of the 510(k) Program with respect to the use of predicate devices and encourage the evolution of safer and more effective medical devices.

These draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidances, when finalized, will represent the current thinking of FDA on the topics discussed in “Evidentiary Expectations for 510(k) Implant Devices,” “Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions,” and “Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission.” These draft guidances 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.

II. Electronic Access

Persons interested in obtaining copies of these draft guidances may do so by downloading electronic copies from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/​medical-devices/​device-advice-comprehensive- regulatory-assistance/​guidance-documents-medical-devices-and-radiation-emitting-products . These guidance documents are also available at https://www.regulations.gov, https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents, or https://www.fda.gov/​vaccines-blood-biologics/​guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of “Evidentiary Expectations for 510(k) Implant Devices” (document number GUI00020017), “Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions” (document number GUI00020016), or “Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission” (document number GUI00020006) may send an email request to [e-mail] to receive an electronic copy of the document. Please use the document number and complete title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

While these guidances contain no new collection of information, they do refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521). The collections of information in the following table have been approved by OMB:

21 CFR part; guidance; or FDA form	Topic	OMB control No.
807, subpart E	Premarket notification	0910–0120
“Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program”	Q-Submissions and Early Payor Feedback Request Programs for Medical Devices	0910–0756
800, 801, 809, and 830	Medical Device Labeling Regulations; Unique Device Identification	0910–0485
803	Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user facility reporting, distributor reporting	0910–0437
810	Medical Device Recalls	0910–0432
820	Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation	0910–0073
822	Postmarket Surveillance of Medical Devices	0910–0449
Forms FDA 3500 and FDA 3500A	Medical device adverse event reporting—MedWatch	0910–0291
58	Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies	0910–0119

Dated: September 1, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.

Footnotes

1.  Available at https://www.fda.gov/​about-fda/​cdrh-reports/​medical-device-safety-action-plan-protecting-patients-promoting-public-health.

2.  Available at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​510k-program-evaluating-substantial-equivalence-premarket-notifications-510k.

3.  Available at https://wayback.archive-it.org/​7993/​20190206202131/​https://www.fda.gov/​AboutFDA/​CentersOffices/​OfficeofMedicalProductsandTobacco/​CDRH/​CDRHReports/​ucm604500.htm. Public comments submitted can be searched under the docket FDA–2018–N–4751, available at https://www.regulations.gov/​docket/​FDA-2018-N-4751.