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FDA Highlights Exemptions for Real World Data-identified AEs



On December 20, the FDA updated its Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices web page to remind manufacturers that it has granted several exemptions to its Medical Device Reporting (MDR) requirements related to events identified in certain real-world data (RWD) sources, such as medical device registries.

The exemptions were granted on a case-by-case basis, and the FDA did require, as a condition of the exemption, summary medical device reports, which were then posted in the FDA’s public MAUDE database.

The FDA uses MDR as a postmarket surveillance tool to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of medical devices.

Manufacturers, importers, and user facilities can request an exemption or variance from any or all MDR requirements in certain situations.

Manufacturers who wish to request a new exemption, variance, or alternative—or to request a modification to an existing exemption—may contact the FDA at Requests should include the following information:

  • Information necessary to identify you and the device(s), including:
    • Firm’s FDA Establishment Identifier (FEI) number (if available) and contact information, including email address
    • Premarket authorization numbers (for example, premarket approval application or 510(k) number) for all devices for which the exemption is requested
    • Copy of any relevant FDA premarket authorization letters, if available
    • Electronic copy or link to current version of the Instructions for Use (IFU) for all devices for which the exemption is requested
  • Exemption Number, if the request is for the modification of a previously granted, currently active exemption
  • A complete statement of the request for exemption, variance, or alternative reporting
  • An explanation of why your request is justified
  • A description of the RWD source and planned analyses, if any
  • If related to events that may be identified in medical device registries, a description of the registry, its sponsor, and the event types captured and reported, including any Case Report Forms for the registry.

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