The FDA has finalized a program that allows manufacturers to submit quarterly summaries of malfunctions related to lower-risk medical devices.
Creating the program frees manufacturers of Class I and certain Class II devices from the need to submit individual medical device reports (MDRs) whenever they learn of a malfunction.
Manufacturers participating in the program must still file an individual MDR if they learn one of their devices may have caused or contributed to a death or serious injury.
The FDA committed to streamline malfunction reporting when negotiating the Medical Device User Fee Amendments 2017 (MDUFA IV) with industry. That commitment built on the findings of a 2015 MDR reporting pilot and led to the publication of a draft proposal late last year. Having assessed the 24 responses to the proposal, the FDA has finalized the program.
Moving to to reduce burden on itself and the industry, the FDA is permitting manufacturers of certain lower-risk devices to collate summaries of malfunction reports and submit them every three months. The FDA thinks this strikes a better balance between burden and benefit than the current model, which contributes to the agency receiving hundreds of thousands of MDRs a year.
The program is open to Class I and Class II devices, provided they are not permanently implantable, life supporting or life sustaining. However, not all product codes within these classes are eligible. A product covered by a code created less than two years ago must comply with the old requirements.
Some criticized the proposal for not going far enough, arguing that the FDA is obligated to immediately implement quarterly reporting for all malfunctions of lower-risk devices. Others criticized the proposal for going too far, citing concerns that the program will deprive the FDA of critical adverse event information. The FDA disagrees with both these criticisms.
“The FDA previously piloted a version of the program and identified several benefits, including more efficient review and understanding of malfunction issues and, because summary reports bundle similar malfunction events for a device, improved ability to identify related adverse events and trends. These benefits can be achieved without compromising effective surveillance,” FDA Commissioner Scott Gottlieb said in a statement.
The FDA published the final program alongside proposed changes to other aspects of its approach to medical devices. In a draft guidance, the FDA detailed why it may deny a request for a Certificate to Foreign Government, a document that confirms a device has been cleared or approved for sale in the U.S. The FDA also began a consultation on the use of general controls to assure the safety and effectiveness of accessories used in the insertion of ureteral stents and other procedures.