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US FDA Recommendations for Voluntary Recalls of Medical Devices and Products

Final guidance from US FDA covers how manufacturers and distributors should develop and initiate voluntary recalls of products including medical devices, IVDs and pharmaceuticals. Learn more at Emergo by UL.

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March 13, 2022

The US Food and Drug Administration has finalized guidance on recommended steps medical device, drug and other manufacturers and distributors for initiating and managing voluntary recalls of products falling under the agency’s jurisdiction.

The final guidance establishes a "recall ready" approach applicable to any organization in a product distribution chain. Such an approach includes general preparations as well as more specific procedures for initiating recalls, discussed below.

General preparations for medical device and IVD voluntary recalls

General preparations recommended by the guidance for entities including medical device and in vitro diagnostic (IVD) device manufacturers include staffing considerations such as identifying appropriate personnel to take on recall-related responsibilities as well as ensuring adequate training of those employees in order to perform their recall-related duties.

Additional general preparatory steps should include:

  • Establishing recall communications plans covering internal as well as external purposes; plans should also cover communications with FDA regarding recall efforts;
  • Identifying reporting requirements to FDA for distributed devices and products;
  • Using appropriate product coding such as product identifiers for prescription drugs and devices; and
  • Maintaining distribution records as required for products such as finished medical devices.

Recommended procedures for initiating and managing recalls

Next, the guidance recommends that companies develop and maintain written procedures that cover initiating and overseeing product recalls. Elements of written procedures could include actions such as ceasing distribution and sales of recalled products; developing recall strategies; and notifying customers and clients regarding products or devices subject to a voluntary recall initiative.

FDA also provides recommendations for manufacturers, distributors and other entities regarding investigating problems related to recalls as well as assigning clear responsibilities and processes to support prompt decisions and actions regarding whether to initiate device recalls.

Working with FDA to initiate a medical device product recall

Last, the guidance explains how companies may coordinate their recall efforts with FDA regulators via the agency’s Office of Regulatory Affairs (ORA). Firms should be aware that once FDA has discussed their voluntary recall plans with them, the agency may request what’s known as an FDA-requested recall under 21 CFR Part 7.45; for medical devices in particular, FDA may declare mandatory product recalls under 21 CFR Part 820 quality management system requirements.

Learn more about US FDA medical device and IVD regulations:

  • US FDA eMDR adverse event reporting support for medical device companies
  • FDA Form 483 warning letter analysis, response and recovery consulting

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