The entire medical device community is waiting patiently to see how the U.S. Food and Drug Administration changes the 510(k) clearance process. In January 2011, the Agency announced a plan containing 25 actions it intends to implement during the year to improve the most common path to market for medical devices.
According to a press release, the FDA’s key actions include:
- Streamlining the “de novo” review process for certain innovative, lower-risk medical devices
- Clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process
- Establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making