Bill Proposes to Change How FDA Reviews Medical Devices

Oct 24, 2011   
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On October 14, 2011, Representative Brian Bilbray introduced a bill before the U.S. House of Representatives, entitled the “Novel Device Regulatory Relief Act of 2011.” The Bill, which seeks to amend the federal Food, Drug and Cosmetic Act (FDCA), focuses specifically on altering the way that medical devices are reviewed by the U.S. Food and Drug Administration (FDA).

Found here, the Bill focuses on changing the FDA’s de novo review process. The de novo process is currently a separate review pathway for medical devices, created to be particularly useful for manufacturers of lower risk devices that do not require formal FDA approval via the Premarket Approval (PMA) process. Differing from the 510(k) process, de novo review may currently only be initiated after a device has been issued a Not Substantially Equivalent (NSE) letter by the FDA. In short, this means that the only devices that may seek de novoreview are those that have not been cleared via the 510(k) process. The newly introduced legislation may revamp this underutilized pathway by allowing manufacturers to submit a request for de novo review “. . . without regard to whether such person has received written notice of classification into class III.”

While the de novo review process has not proven effective in practice and has been widely criticized for lack of transparency, the FDA has been working to change the process throughout 2011. As we previously reported, the FDA recently released its plans to streamline the de novo review process, publishing its draft guidance entitled “De Novo Classification Process (Evaluation of Automatic Class III Designation),” on September 30, 2011. However, as shown in the guidance, the FDA’s plans may not have proven as effective as industry had hoped. Where the FDA had planned to introduce a process whereby a pre de novo submission (PDS) would be submitted concurrently with a 510(k) petition, it is unclear how this would have resolved the issues confronting the de novo process. Because the statutory language of the FDCA only allows for initiation of de novo review upon the issuance of a NSE letter, this new legislation may actually result in increased utilization of the de novo review process.

Fuerst Ittleman has extensive experience successfully navigating medical devices through FDA review. For more information on FDA’s review of medical devices, please contact us at