2023-25458. Notifying the Food and Drug Administration of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act; Final Guidance for Industry and Food and Drug ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance entitled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act” and the draft guidance entitled “Select Updates for the 506J Guidance: 506J Device List and Additional Notifications.” The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires manufacturers to notify FDA of a permanent discontinuance or an interruption in the manufacture of certain devices that is likely to lead to a meaningful disruption in supply of that device in the United States during or in advance of a public health emergency (PHE). This final guidance is intended to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical device products that will help prevent or mitigate shortages of such devices. FDA is concurrently issuing a draft guidance to propose select updates to the final guidance “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act.” This draft guidance proposes a list of device product codes for which a manufacturer of such devices is required to notify FDA in accordance with the FD&C Act (hereafter referred to as the “506J Device List”) and clarifies that manufacturers may submit voluntary notifications regarding supply chain issues at any time, unrelated to the declaration or potential declaration of a PHE. This draft guidance is not final nor is it for implementation at this time.

DATES:

Submit either electronic or written comments on the draft guidance by February 15, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 the Docket No. FDA–2022–D–0053 for “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act” or “Select Updates for the 506J Guidance: 506J Device List and Additional Notifications.” 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 final guidance document entitled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act” or draft guidance document entitled “Select Updates for the 506J Guidance: 506J Device List and Additional Notifications” 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; or to Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT:

Tammy Beckham, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5550, Silver Spring, MD 20993–0002, 301–796–9081; or Anne Taylor, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240–402–7911.

SUPPLEMENTARY INFORMATION:

I. Background

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law. Section 3121 of the CARES Act amends the FD&C Act by adding section 506J to the statute. Section 506J of the FD&C Act (21 U.S.C. 356j) provides FDA with new authorities intended to help prevent or mitigate device shortages “during, or in advance of, a public health emergency” declared under section 319 of the Public Health Service Act (PHS Act) (42 U.S.C. 247d). Additionally, on December 29, 2022, the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (“PREVENT Pandemics Act”) was signed into law as part of the Consolidated Appropriations Act, 2023, Pub. L. 117–328 (hereafter referred to as the “FY 2023 Omnibus”). Section 2514(c) of the FY 2023 Omnibus directed FDA to issue or revise guidance regarding requirements under section 506J and include a list of each device product code for which a manufacturer of such device is required to notify FDA in accordance with section 506J. Section 2514 the FY 2023 Omnibus amended section 506J to add section 506J(h), “Additional Notifications” and directed FDA to issue guidance “to facilitate voluntary notifications.”

FDA is issuing this final guidance, “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act” (hereafter referred to as the “506J Guidance”) to assist stakeholders in the Agency's implementation of section 506J. This guidance serves as the baseline for information about notifications under section 506J during or in advance of any PHE. FDA provides additional clarification on who is required to notify FDA, when such notifications are required, what information FDA expects manufacturers to include in such notifications, and how to submit notifications. Additionally, FDA describes how FDA determines that a device is in shortage and additional actions FDA may take to help prevent or mitigate a potential device shortage.

In the draft guidance “Select Updates for the 506J Guidance: 506J Device List and Additional Notifications,” FDA proposes updates to the 506J Guidance. Specifically, FDA has developed a list of devices, by FDA product code, for which a manufacturer of such devices is required to notify FDA in accordance with section 506J (hereafter referred to as the “506J Device List”). The 506J Device List is based on the requirements under section 506J(a). In section 2514 of the FY 2023 Omnibus, Congress directed FDA to issue guidance on the requirements under section 506J and to include “a list of each device product code for which a manufacturer of such device is required to notify the Secretary in accordance with section 506J.” Thus, manufacturers of a device on the 506J Device List must notify FDA in accordance with 506J for each such device. For more information, manufacturers should see the 506J Device List web page, available at https://www.fda.gov/​medical-devices/​medical-device-supply-chain-and-shortages/​506j-device-list. Additionally, consistent with section 506J(h), FDA is proposing to clarify for stakeholders that manufacturers may submit, and FDA may receive, voluntary notifications regarding supply chain issues at any time, unrelated to the declaration or potential declaration of a PHE. The Agency invites comments on both the 506J Device List and the clarification for stakeholders on voluntary notifications.

A notice of availability of the draft guidance, “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act,” appeared in the Federal Register of January 11, 2022 (87 FR 1417). FDA considered comments received and revised the guidance as appropriate in response to the comments, including providing additional clarifications such as when manufactures should notify FDA of changes in status and when manufacturers should provide 506J notification updates, and what information is required by section 506J and what additional information is helpful to FDA. Additionally, FDA provided additional transparency regarding how FDA uses information from 506J notifications.

These guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, “Select Updates for the 506J Guidance: 506J Device List and Additional Notifications,” when finalized, will represent the current thinking of FDA on “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act.” These guidances do not establish any rights for any person and is 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 a copy of the draft guidance 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/​medical-devices/​device-advice-comprehensive-regulatory-assistance/​guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is 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 “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act” or “Select Updates for the 506J Guidance: 506J Device List and Additional Notifications” may send an email request to [e-mail] to receive an electronic copy of the document. Please use the document number GUI00021003 and complete title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

While this guidance contains no new collection of information, it does 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:

Guidance	Topic	OMB control No.
“Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act”	Shortages Data Collection	0910–0491

Dated: November 14, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.