Washington, DC — The US Food and Drug Administration has unveiled a plan containing 25 actions it intends to implement during 2011 to improve the most common path to market for medical devices. It is 
unclear how these changs will affect hearing aid device approval, if at all.
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.
These actions will result in “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health (CDRH), in a press release.
In September 2009, CDRH set up two internal working groups to address concerns relating to the premarket notification process—industry argued that the 510(k) process was unpredictable, inconsistent, and opaque, while consumers and health care professionals argued that the review process wasn’t robust enough. At the same time, CDRH also asked the independent, nonprofit Institute of Medicine to study the program. That review is still under way.
After reviewing public comments, CDRH now intends to take 25 actions to improve the 510(k) program in 2011, including new guidance and enhanced staff training.
CDRH also is giving the Institute of Medicine an opportunity to provide feedback on seven recommendations before making a final decision and is planning for a public meeting in April to seek additional feedback on two other recommendations.
More detailed information is available on the FDA Web site.
