Earlier this year, FDA quietly made changes to their 510(k) clearance letters related to combination products cleared via the 510(k) pathway. The letters now include the following language (new text in bold italics):
Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions.
You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
As noted in the second excerpt, the designation of a product as a combination product imposes additional regulatory requirements over those products regulated strictly as medical devices (see our previous blog posts here and here). Therefore, it is something manufacturers want to be aware of to ensure compliance with all applicable regulations. For this reason, FDA’s identification of combination product clearances is a helpful improvement.
We are, however, surprised that FDA has chosen to communicate this important information, i.e., whether the device is a combination product or not, to sponsors solely through the database and not more formally through the clearance letter itself. Although many sponsors are likely aware of their product’s status as a combination product going into or during a 510(k) submission’s review, there are some products where the designation may not be as obvious. Manufacturers should also be aware that the database field has been populated for 510(k)s going back as far as 1993. In a brief review of older 510(k)s marked as a combination product in the database, we found records for products we would not traditionally think of as combination products, such as surgical gowns and drapes, monitoring systems, and defibrillators, which makes us question whether these are unique products or if there might be errors in the database record. We do not know if FDA has a review step as part of its database updates to ensure all information and links are accurate. Therefore, it is a good idea for sponsors to review the database carefully to make sure their products’ designations are correct both for new clearances and also for older products that are still marketed.
* Senior Medical Device Regulation Expert