On October 14, 2011, Representative Brian Bilbray (R-CA) introduced H.R. 3203, the “Novel Device Regulatory Relief Act of 2011.” This bill intends to amend section 513(f) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to expedite the process for requesting de novo classification of a device. The de novo review process is a compromise between the 510(k) clearance process and the more rigorous premarket application (“PMA”) approval process, generally reserved for higher risk devices. It was added to the FDC Act to address novel devices that lack a predicate device but pose only a low to moderate risk, making them ill-suited to the PMA process.
Unfortunately, the current statutory requirements for the de novo process make it difficult and burdensome for both industry and FDA. The statute currently requires that, before submitting a petition for de novo classification to classify a device into class I or II, the manufacturer must submit a 510(k) notification to FDA and await a determination that the device is not substantially equivalent (“NSE”) and therefore classified into class III, even if the manufacturer knows there is no appropriate predicate.
Representative Bilbray’s proposal would eliminate this often unnecessary step by allowing a request “without regard to whether such person has received written notice of classification into class III . . . .” In other words, if a manufacturer knows there is no appropriate predicate for a proposed moderate- to low-risk device, the manufacturer could skip the 510(k) process and submit a de novo petition first. Of course, it would probably be desirable for the manufacturer to have an understanding with FDA that a de novo petition is the best approach. Thus, there will be a need for advance discussions. Nonetheless, this simple change would give FDA more flexibility.
This provision should be non-controversial, and acceptable to both industry and FDA. As discussed in our previous blog post, FDA recently issued a Draft Guidance revising the de novo classification process in an attempt to make the process more efficient. Given the current statutory language, however, FDA was constrained to continue to require a 510(k) filing. Representative Bilbray’s language would do away with this requirement, potentially making the de novo process more appealing to both FDA and industry.