Notifying FDA of a permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act: guidance for industry and Food and Drug Administration staff
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Devices and Radiological Health (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, November 17, 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Correspondence as Topic Device Approval Government Regulation Manufacturing Industry United States United States.
- Genre(s):
- Guideline Technical Report
- Abstract:
- The Food and Drug Administration (FDA or Agency) is issuing this guidance to address section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Pub. L. No. 116-136 (March 2020), as it relates to notifying FDA of a permanent discontinuance or interruption in the manufacturing of a device that is likely to lead to a meaningful disruption in the supply of that device during or in advance of a public health emergency (PHE). FDA plays a critical role in protecting the United States from threats, such as emerging infectious diseases, and other PHEs. Section 506J requires manufacturers to notify FDA, during or in advance of a PHE, of a permanent discontinuance in the manufacture of certain devices 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. This guidance is intended to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical devices that will help prevent or mitigate shortages of such devices. This guidance also recommends that manufacturers voluntarily provide additional information to better ensure FDA has the specific information it needs to help prevent or mitigate shortages during or in advance of a PHE. FDA is issuing this 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 (hereafter referred to as “506J notifications”) during or in advance of any PHE. If FDA determines it is appropriate, we may issue individual, PHE-specific updates as appendices to this guidance or individual, PHE-specific guidance documents, among other potential options. Such decisions will be made on a case-by-case basis and will be determined by the specific situation and informational need. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (15 pages))
- NLM Unique ID:
- 9918733188806676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918733188806676