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 in order 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 for the protection of 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 Medical Device Registries
- Public Access to MDR Information, Including Data Submitted Under Registry Exemptions
- How to Request an Exemption, Variance, or Alternative
The FDA has granted several exemptions related to events identified in certain medical device registries.i The FDA has 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 has required, as a condition of the exemption, summary medical device reports (MDRs) and has posted these MDRs in the FDA’s public MAUDE database. These exemptions do not change a manufacturer’s responsibility to investigate each event, evaluate the cause of the event, or submit individual reports when required.
Registries for medical devices are a key component of the National Evaluation System for health Technology (NEST) – an active surveillance system the FDA has worked on since 2012, to systematically use real-world data to rapidly identify and address safety concerns once devices are on the market. Modernized, active surveillance that uses real-world data is the future of medical device safety signal detection, and is a primary focus for the FDA, as noted in our Medical Device Safety Action Plan.
Registries 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 also improve the ability to link adverse events with specific devices, facilitating rapid identification of safety issues and enabling timely, evidence-based decisions to mitigate device risks and maximize patient safety. Because of the benefits of this active surveillance, CDRH encourages the development of robust registries and appropriate regulatory uses of the resulting data, which may include post-market adverse event reporting.
The FDA continues to be committed to transparency, including making more medical device report (MDR) information easily accessible and useful to the public. In the spirit of promoting public transparency and availability of information submitted under exemptions, such as those granted for registries, in September 2020, the FDA:
- Added new Summary Reporting, Number of Events, and Exemption Number fields to eMDR, eSubmitter, and the Manufacturer and User Facility Device Experience (MAUDE) database. These fields will help identify MDR reports that are related to exemptions granted by FDA. This information was previously only captured in narrative form in sections B5 and H10 of FDA Form 3500A.
- By the end of 2020, MAUDE data for previously submitted MDRs will be updated to include this information in these newly-available data fields.
- By February 28, 2021, the FDA expects submitters to use these new data fields, in place of entering the information in narrative sections of FDA Form 3500A
- Updated the MAUDE database to supplement previously submitted MDRs related to registry exemptions with more detailed information on individual events, which was previously available only to FDA. The addition of these data in comma-separated values (CSV) format in public MAUDE, along with additional resources to understand and make use of this information, will allow the public to more easily analyze these events.
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 CDRH’s information technology systems, furthering our efforts to increase transparency in medical device reporting as part of the Digital Transformation Initiative.
Manufacturers who wish to request a new exemption, variance, or alternative—or to request a modification to an existing exemption—may contact CDRH at [email protected]. Per 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 Approval (PMA) or Premarket Notification (510(k)) numbers for all devices for which the exemption is requested
- Copy of any relevant FDA PMA approval or 510(k) clearance 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
- 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
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.”