Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices
Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803, under 21 CFR 803.19(b).
If granted, these exemptions and variances permit deviations from specified aspects of these reporting requirements, as determined by the FDA. When granting an exemption or variance, the FDA may impose specific reporting conditions beyond those listed in 21 CFR Part 803 to protect public health. These conditions may involve the:
- Specific devices covered by the exemption, variance, or alternative form of adverse event reporting
- Contents of the subsequent reports
- Timeframes or mechanism for submitting these reports, or other reporting aspects
The FDA may also revoke or modify an exemption, variance, or alternative if it is determined that the revocation or modification is necessary to protect the public health.
The FDA's review of requests for exemptions and variances involves evaluating the suitability of the request on a case-by-case basis and assuring appropriate reporting conditions.
Releasable adverse event information submitted to the FDA as part of a reporting exemption, variance, or alternative is also made publicly available through the Manufacturer and User Facility Device Experience (MAUDE) database.
On this page:
- Exemptions Granted for Adverse Events Identified in Certain Medical Device Real-World Data Sources
- Public Access to MDR Information, Including Data Submitted Under Granted Exemptions
- How to Request an Exemption, Variance, or Alternative
Exemptions Granted for Adverse Events Identified in Certain Medical Device Real-World Data Sources
The FDA has granted several exemptions related to events identified in certain real-world data (RWD) sources, such as medical device registries.i For example, the FDA received requests for exemptions from some of the adverse event reporting requirements in 21 CFR Part 803 from individual manufacturers requesting to submit summary information regarding certain adverse events identified in specific registries for a specific device, and the FDA has granted these exemptions on a case-by-case basis. In these cases, the FDA required, as a condition of the exemption, summary medical device reports (MDRs) and posted these MDRs in the FDA's public MAUDE database.
Additional RWD sources utilized by medical device manufacturers include electronic health records (EHR) and medical claims.
Medical device registries, EHRs and medical claims provide a valuable function by continuously capturing—and allowing evaluation of—a large volume of real-world post-market clinical data on medical devices. Registries, EHRs and medical claims may also facilitate rapid identification of safety issues and enable timely, evidence-based decisions to mitigate device risks and maximize patient safety. Because of the potential benefits of RWD, the FDA encourages the development of robust RWD sources and appropriate regulatory uses of the resulting data, which may include post-market adverse event reporting.
i The International Medical Device Regulators Forum (IMDRF) defines "medical device registry" as: "An organized system that continuously and consistently collects relevant data in conjunction with routine clinical care, evaluates meaningful outcomes, and comprehensively covers the population defined by exposure to particular device(s) at a reasonably generalizable scale (e.g. international, national, regional, and health system) with a primary aim to improve the quality of patient care." (International Medical Device Regulators Forum (IMDRF) Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making-March 27, 2018).
Public Access to MDR Information, Including Data Submitted Under Granted Exemptions
The FDA continues to be committed to transparency, including making more medical device report (MDR) information easily accessible and useful to the public in these ways:
- The eMDR, eSubmitter, and the Manufacturer and User Facility Device Experience (MAUDE) database have Summary Reporting, Number of Events, and Exemption Number fields.
- These fields help identify MDR reports that are related to exemptions granted by the FDA. This information was previously only captured in narrative form in sections B5 and H10 of FDA Form 3500A.
- The FDA expects submitters to use these data fields, in place of entering the information in narrative sections of FDA Form 3500A
- MAUDE data for previously submitted MDRs includes this information in these data fields.
- The MAUDE database has detailed information on individual events. The data is available in a comma-separated values (CSV) format, along with additional resources to understand and make use of this information.
The FDA is also actively working to improve usability of the MAUDE database in the next few years as part of a broader effort to modernize the FDA's information technology systems, furthering our efforts to increase transparency in medical device reporting as part of the Digital Transformation Initiative.
How to Request an Exemption, Variance, or Alternative
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 MDRPolicy@fda.hhs.gov. When submitting a request under 21 CFR 803.19(b), the request 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.