Senator Brown Proposes Modifications to the De Novo ProcessDecember 6, 2011
On December 5, 2011, Senator Scott Brown (R-MA) introduced S. 1943, the “Novel Device Regulatory Relief Act of 2011.” The bill is intended to amend section 513 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.
Senator Brown’s bill builds on and clarifies language proposed by Rep. Brian Bilbray in October to modify the de novo process, discussed in our previous blog post. Both bills include language allowing a sponsor to submit a de novo classification request without awaiting a written determination from FDA that the device is not substantially equivalent (“NSE”) and therefore classified into class III, even if the manufacturer knows there is no appropriate predicate. That is the only change proposed in Rep. Bilbray’s bill, and therefore left open the question of whether the sponsor would nevertheless be required to submit the 510(k), or if the sponsor need not submit the 510(k) and could instead submit the de novo petition first. As discussed in our previous blog post, we interpreted the language in Rep. Bilbray’s bill to allow the sponsor to submit a de novo petition without submitting a 510(k) notification.
The language proposed by Senator Brown appears to clarify this ambiguity. He adopts the same language proposed by Rep. Bilbray, permitting a sponsor to submit a de novo petition without awaiting a written notification of a class III determination. He also proposes language stating that “[a]ny person that is required to submit” a 510(k) notification, and determines that there is no applicable predicate device, “may submit a request for initial classification of the device” and may recommend a specific classification to FDA. The bill states that FDA may decline the petition if it believes an appropriate predicate device exists.
The addition of this language clarifies that adoption of this bill would provide two distinct alternatives for 510(k) submitters who believe no appropriate predicate device exists for their low- to moderate-risk device: (1) submit a 510(k) knowing that no predicate exists, and then submit a de novo petition before receiving an NSE determination, or (2) submit a de novo petition without submitting a 510(k) notification. While both options improve upon the current requirement to submit a 510(k) notification and await a written determination, it seems that most applicants would elect the second option—submit the de novo petition without submitting a 510(k) notification. As discussed in our previous blog post, the sponsor should probably seek input from FDA prior to submitting an initial classification request, to determine whether FDA agrees that the de novo approach is appropriate. Given the current inefficiencies associated with the de novo process, this seems like something both parties should be willing to do.