The Food and Drug Administration (“FDA”) oversees the approval, regulation and safety of drugs and medical devices. There are two ways for medical device manufacturers to have their products approved by the FDA: Premarket Approval and 510(k) Premarket Notification. This month, the FDA issued guidance and requested comments in its effort to strengthen and modernize approval of medical devices under its 510(k) Premarket Notification process.
What is the 510(k) Premarket Notification process?
This approval process requires a device manufacturer to notify the FDA that it intends to market a device in 90 days. The manufacturer is not required to submit proof that the product is safe. It must only show that the new product is “substantially equivalent” to a medical device already approved by the FDA. The FDA approves the product if it determines a new device is substantially equivalent to a device that is already on the market.
Products approved under the 510(k) Premarket Notification process are primarily Class I and Class II medical devices. These include devices that are not normally life threatening. Examples include bandages, sutures, and dental floss.
However, some devices approved through the 510(k) have proven to be problematic. For example, vaginal mesh products were approved through the less stringent 510(k) process. However, they were the subject of much litigation due to severe injuries they caused thousands of women after implantation. Since then, numerous notices and safety communications have been issued by the FDA concerning the risks of vaginal mesh.
What does the FDA’s guidance and request for comments on the 510(k) process include?
The FDA recognizes that medical devices are becoming more complex. As such, it offers guidance and requests comments on the following subjects:
- Selecting a preapproved device to support 510(k) approval. Guidance includes selecting a device that was previously approved, meets expected safety regulations, and has not been recalled.
- Use of clinical data in 510(k) approval submissions. Guidance provides clarity in situations where clinical data may be necessary to prove substantial equivalence.
- Expectations for 510(k) approval of implants. Medical device-specific guidance is provided when using documents to support 510(k) approval.
Why are the FDA’s recent actions important?
Hopefully, modernizing the 510(k) process will strengthen medical device approval and protect the public from potentially harmful products