90 FR 4 pgs. 1152-1154 - 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; Guidance for Industry and Food and Drug Administration Staff; Availability
Type: NOTICEVolume: 90Number: 4Pages: 1152 - 1154
Pages: 1152, 1153, 1154Docket number: [Docket No. FDA-2022-D-0053]
FR document: [FR Doc. 2024-31547 Filed 1-6-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0053]
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; Guidance 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 a final guidance entitled "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act." This guidance updates the previous version of the guidance, of the same title, issued on November 17, 2023, and finalizes the concurrently issued draft guidance entitled "Select Updates for the 506J Guidance: 506J Device List and Additional Notifications." This guidance finalizes a list of device product codes for which a manufacturer of such devices is required to notify FDA in accordance with the Federal Food, Drug, and Cosmetic Act (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 public health emergency (PHE).
DATES:
The announcement of the guidance is published in the Federal Register on January 7, 2025.
ADDRESSES:
You may submit either electronic or written comments on Agency guidances 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." 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.
[top] 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 guidance document entitled "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act" 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:
Tammy Beckham, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5500, Silver Spring, MD 20993-0002, 301-796-9081 or James Myers, 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
Section 506J of the FD&C Act (21 U.S.C. 356j) provides FDA with 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). On December 29, 2022, the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act was signed into law as part of the Consolidated Appropriations Act, 2023, Public Law 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 of the FD&C Act 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 of the FY 2023 Omnibus amended section 506J of the FD&C Act to add section 506J(h), "Additional Notifications" and directed FDA to issue guidance "to facilitate voluntary notifications."
This final guidance includes the 506J Device List. The 506J Device List is based on the requirements under section 506J(a) of the FD&C Act. In section 2514 of the FY 2023 Omnibus, Congress directed FDA to issue guidance on the requirements under section 506J of the FD&C Act 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 section 506J of the FD&C Act 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 . FDA expects that the list will evolve over time and FDA intends to periodically reevaluate the list.
Additionally, consistent with section 506J(h) of the FD&C Act, FDA has clarified 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.
This guidance updates 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 guidance also finalizes the concurrently issued draft guidance entitled "Select Updates for the 506J Guidance: 506J Device List and Additional Notifications." A notice of availability for these guidances appeared in the Federal Register of November 17, 2023 (88 FR 80310). Additionally, FDA received recommendations from the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee on February 6, 2024. FDA considered comments received and revised the draft guidance as appropriate in response to the comments, including updating the 506J Device List and providing additional clarity regarding the development of the 506J Device List. The guidance also includes additional information regarding potential updates to the 506J Device List and how to contact FDA regarding devices on the 506J Device List.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents 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." It does 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 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" may send an email request to CDRH-Guidance@fda.hhs.gov 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 |
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Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31547 Filed 1-6-25; 8:45 am]
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