FDA Finalizes Guidance on Annual Reports for Approved PMAs

Regulatory NewsRegulatory News | 14 January 2020 |  By 

The US Food and Drug Administration (FDA) last month altered and finalized a 2014 draft guidance explaining what information needs to be provided in annual reports for medical devices subject to premarket approval (PMA).

In terms of the changes between the draft and final version, FDA clarifies the wording on its expectations and offers further detail on what it’s looking for in the report. For instance, in the final guidance, the recommended format for the table of annual reportable changes includes additional columns devoted to the type of change, a description of the change, related changes and why a change does not impact the safety and effectiveness of the device.

The final guidance also offers additional examples of rationales for device changes, such as, “made as a result of a device improvement or enhancement.” The new document further explains how FDA, since August 2009, requires device manufacturers to provide the agency with data about the number of devices shipped or sold within the reporting period.

Usually within 90 days, FDA says it will complete its review of the annual report and will either acknowledge the review is complete, alert firms to any requests for additional information and/or issue a letter notifying the applicant that a PMA supplement or 30-day notice is required for certain changes within a specified timeframe.

The final guidance also adds a new section at the end of the 8-page document explaining how FDA may require post-approval studies and periodic reporting on the safety, effectiveness and reliability of the device for its intended use (known as post-approval study reports).

“If your approval order identifies post-approval studies you must conduct, the order will describe the purpose of the studies and how frequently you must submit post-approval study reports. Please submit your annual report and post-approval study report separately, even if they are due at the same time, and identify the date that you submitted your post-approval study report in your annual report,” the final guidance adds.

FDA this week also published a new educational module on device postmarket activities.

Annual Reports for Approved Premarket Approval Applications (PMA): Guidance for Industry and FDA staff


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy