Drug & Device News

The Food and Drug Administration (FDA) announced Jan. 19 that it intends to implement a new 25-point plan to improve the path to market for certain medical device products. The system will include a new Center Science Council made up of senior FDA experts whose job will be to ensure timely and consistent science-based decision-making. Under the new plan, de novo review of some innovative, lower risk medical devices will also be streamlined. The changes to the submission process for 510(k)s (so-called for the section of the Federal Food, Drug, and Cosmetic Act that describes this process) are being implemented because industry players working to obtain pre-market approval for low-risk devices (such as catheters and diagnostic imaging tools) found the old system unpredictable and confusing. Consumers and health care providers criticized approvals under the old system for not being rigorous enough. Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health (CDRH), says the planned changes will create “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly.” For more information on specific changes to the approval process, go to: http://www.fda.gov/About
FDA/CentersOffices/CDRH/CDRH Reports/ucm239448.htm