FDA Announces New Regulations Regarding 510(k) Medical Device Reviews

The U.S. Food and Drug Administration revealed Wednesday 25 steps it says will bring about a “smarter” 510(k) review program for medical devices.  The goals of the new guidelines are to support innovation, keep jobs in the U.S. and quickly bring safe and effective new innovative medical devices to patients.

Changes to the 510(k) program require a delicate balancing act by the FDA. On one
Most lower-risk medical devices — such as imaging technology and catheters — that go on the market in the U.S. are cleared through the 510(k) program. Generally, a 510(k) application must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk.

Among the key changes the FDA plans to make are:

• Streamlining the de novo review process for certain lower-risk medical devices
• Clarifying when clinical data should be submitted in a premarket submission
• Establishing a new council of senior FDA experts to assure timely and consistent science-based decision making
• Making device photographs available in a public database without disclosing proprietary information
• Implementing “notice-to-industry” letters to inform the industry of when the FDA has changed regulatory expectations on the basis of new scientific evidence

For complete details, see the story in MedCity News .