At the February 2014 Medical Device Roundtable session, Deborah L. Shuff of Saul Ewing LLP led a discussion about recent trends in medical device regulatory reviews.
Key takeaway tips from the group’s discussion were as follows:
- The need for supportive clinical evidence is a relatively new trend for 510(k)s that appears to have been triggered by heightened public scrutiny of this route to market. As a result, FDA reviewers are less willing to accept bench testing or logic to demonstrate substantial equivalence of the new device to the predicate. In addition, the amount of clinical evidence required to support U.S. FDA submissions may be increasing.
- The need to demonstrate statistical significance to prove clinical effectiveness of a new treatment.
- FDA plans to review devices subject to PMA that are on the market to consider shifting premarket data requirements to postmarket and to also consider down classification of devices in light of a better understanding of the device technology.
- By way of the Pre-Submission Program, FDA intends to provide an efficient path from device concept to market. The discussion included a detailed review of the Pre-Submission Program and the mechanisms by which FDA may provide feedback on the scientific evidence that will be required to demonstrate that a device is effective for its intended use and how to leverage clinical studies in the process.