FDA Proposes Guidance On Discontinuation Or Interruption Of Medical Device Manufacturing

The FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) on Jan. 11, 2022, released draft guidance, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act, for public comment. The FDA is issuing this guidance to implement section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356j), as added by section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).  This draft guidance is not intended to supersede the Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device under Section 506J of the FD&C, which will be withdrawn at the end of the COVID-19 public health emergency.

The FD&C Act Section 506J requires manufacturers to notify the FDA, during or in advance of a public health emergency, 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. When the FDA concludes that there is, or is likely to be, a shortage of a device, then inspections as well as review of submissions may be prioritized and expedited to help mitigate or prevent shortages.

The FDA provides the following aspects for the manufacturer to consider as a permanent discontinuance or meaningful disruption:

• requirements related to complying with good manufacturing practices
• regulatory delay
• order to divert devices from other U.S. government entities
• shortage or discontinuance of a component, part, or accessory of the device
• discontinuance of the manufacture of the device
• delay in shipping of the device
• delay in sterilization of the device
• increase in demand for the device
• facility closure
• device is currently in shortage
• device is expected to be in shortage
• device on backorder
• device on allocation
• device on export or import restrictions
• longer than usual delay from order to delivery

Manufacturers must submit a notification at least six months in advance of a permanent discontinuance or interruption in manufacturing of a device that is likely to lead to a meaningful disruption in supply of the device in the United States. If that timeframe is not possible, notification should be done “as soon as is practicable” (no later than 7 calendar days after the discontinuance or interruption in manufacturing occurs).

The FDA recommends that manufacturers provide updates every two weeks unless otherwise indicated based on the nature of the situation, including the expected timeline for recovery, even if the status remains unchanged. When circumstances pertaining to the 506J notification change, the manufacturer should notify FDA of the change.

FDA recommends that manufacturers ask the following questions to determine whether they manufacture medical devices for which a notification is required during or in advance of a public health emergency. Is the device (with or without accessories):

• life-supporting, life-sustaining, or intended for use in emergency medical care?
• used to diagnose, cure, treat, mitigate, or prevent a disease that is related to a pandemic or other public health emergency?
• in higher-than-typical demand during the response to a pandemic or other public health emergency compared to a similar period?

Additionally, the FDA has provided a list of types of medical devices to help manufacturers determine Section 506J notification obligations.

When the manufacturer is not certain whether to notify FDA about a particular device or interruption, they are encouraged to contact CDRHManufacturerShortage@fda.hhs.gov for devices regulated by CDRH and cbershortage@fda.hhs.gov for devices regulated by CBER for clarification.

Additionally, the FDA recommends manufacturers voluntarily submit additional information, including manufacturing pressures, labor shortages, supply chain interruptions, backorders, allocations, cybersecurity vulnerabilities, potential prevention or mitigation strategies, inventory and production capacity, and potential expansion capabilities.

When the FDA concludes that there is, or is likely to be, a shortage of a device, a letter will be issued to the manufacturer when the manufacturer fails to submit the required information in accordance with the specified timelines. The manufacturer must respond to the FDA’s letter not later than 30 calendar days after issuance of the letter, explaining the reason for noncompliance and providing the required information on the discontinuance or interruption.

Appendix A of the guidance provides an example 506J Notification Template that can be used for manufacturers to submit notifications to CDRH or CBER as appropriate.

Public comment on the guidance document will be accepted through March 11, 2022. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 or electronic comments to https://www.regulations.gov. Please reference docket number FDA-2022-D-0053 and the complete title of the guidance with all comments. As an industry, I hope we can continue to interact with the FDA, enabling the public to build confidence in the industry and the FDA.

About The Author:

Mark Allen Durivage has worked as a practitioner, educator, consultant, and author. He is Managing Principal Consultant at Quality Systems Compliance LLC, an ASQ Fellow and SRE Fellow. He earned a BAS in computer aided machining from Siena Heights University and an MS in quality management from Eastern Michigan University. He holds several certifications including CRE, CQE, CQA, CSQP, CSSBB, RAC (Global), and CTBS. He has written several books available through ASQ Quality Press, published articles in Quality Progress, and is a frequent contributor to Life Science Connect. Durivage resides in Lambertville, Michigan. Please feel free to email him with any questions or comments.