Continually Increasing FDA Scrutiny Could Mean Major Expansion of Role for Regulatory Affairs: Cutting Edge Information Conducting Survey of Regulatory Affairs Trends

RESEARCH TRIANGLE PARK, NC--(Marketwire - April 29, 2009) - Earlier this month, as reported in the Wall Street Journal, the FDA requested further proof from a number of medical device companies concerning the safety and efficacy of medical devices already on the market. The move raises the possibility that companies will have to conduct costly clinical trials for devices already on the market. It also alerts the industry that approval of medical devices could soon become a more difficult and protracted process.

The requests come in response to a number of reports questioning the rigor of medical device testing and approval at the FDA. The move also returns to a previous initiative from the 1990s, which required the FDA to require extensive evidence for devices falling into Class 3 approval, the most risky class. New requirements could require much more evidence to be collected in clinical trials rather than in laboratories.

In addition to the impact this will have on medical device timelines, the request by the FDA is indicative of what seems to be a larger trend for the FDA and regulatory agencies worldwide. With evidence requirements becoming more robust and stringent and submission timelines protracting, strong relationships and early and frequent communication with regulatory bodies will be integral to efficiently bringing a product to the market. Companies will need to focus on improving and bolstering their regulatory affairs functions and activities. The shift in regulatory agencies' requirements and behaviors leaves companies trying to find the best way to adjust to the new demands and regulatory atmosphere.

For these reasons, Cutting Edge Information is now conducting a study on Regulatory Affairs. Findings will show how companies set new directions for their regulatory groups, build strategies to improve their engagement with regulatory bodies and trim submission guidelines. If you are interested in participating in the research, please go to http://www.cuttingedgeinfo.com/studies/PH132/regulatoryaffairs.htm and fill out the survey. Participants will receive a complimentary set of findings relating the latest in Regulatory Affairs trends and strategies.

Contact Information: CONTACT INFORMATION: Jordan Stone 919-433-0376