FDA Finalizes Program for Medical Device Reporting in Summary Form for Certain Manufacturers

The US Food and Drug Administration (FDA) issued an order in the Federal Register on August 17 announcing a new “Voluntary Malfunction Summary Reporting Program.” FDA issued this order to implement certain provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which amended the Medical Device Reporting (MDR) requirements under the Federal Food, Drug, and Cosmetic Act to allow reporting of malfunctions for certain Class I and Class II devices in summary form on a quarterly basis, in accordance with criteria to be established by FDA.

FDA’s regulations at 21 CFR Section 803.50(a)(2) require device manufacturers to submit an MDR within 30 days of becoming aware of a device malfunction that would likely cause or contribute to a death or serious injury should the malfunction recur. The Voluntary Malfunction Summary Reporting Program, however, will provide an alternative method of compliance for malfunctions that involve Class I and Class II devices that are not permanently implantable, life supporting, or life sustaining. Effective August 17, 2018, FDA is allowing device manufacturers to report malfunctions associated with such devices on a quarterly basis in the summary format set forth in FDA’s August 17 order. To provide clarity on which Class I and Class II devices are eligible for this voluntary program, FDA has updated its online Product Classification Database to include a field for “Summary Malfunction Reporting.” Thus, device manufacturers will be able to use this database to determine whether devices in a particular product code are “eligible” or “ineligible” for voluntary summary reporting.

FDA’s August 17 order also describes certain malfunction types that are not eligible for summary reporting (even for eligible Class I and II devices), including the following:

• A malfunction that results in a death or serious injury event that must be reported per 21 CFR Section 803.50(a)(1)
• A malfunction associated with a five-day report, per 21 CFR Section 803.53
• A malfunction that is the subject of a correction or removal that must be reported per 21 CFR Part 806
• A malfunction for which FDA has determined that individual MDRs are necessary to address a public health issue
• A malfunction for a specific device manufacturer that FDA has determined may not participate in the Voluntary Malfunction Summary Reporting Program
• A new type of device malfunction that the manufacturer has not previously reported to FDA

The program applies only to reportable malfunction events that manufacturers become aware of on or after August 17, 2018. FDA created a summary malfunction reporting schedule, identifying the deadlines to submit malfunction reports to FDA for each quarter:

The Voluntary Malfunction Summary Reporting Program is likely to provide the most benefit for device companies that submit a high number of MDRs for eligible Class I and Class II devices. For companies with smaller numbers of MDRs or that have relatively few eligible devices, the benefits of quarterly reports may not outweigh the costs and expenses of having to update internal processes and procedures.

Contacts

If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis lawyers:

Washington, DC
Michele Buenafe