FDA has issued draft guidance on the de novo device approval process, indicating that the agency will allow manufacturers to submit device for de novo approval at the same time as they are submitted for 510(k) approval.

Thomas Blair

September 30, 2011

2 Min Read
FDA Releases Draft Guidance on De Novo Classification Process

FDA has issued draft guidance on the de novo device classification process, indicating that the agency will allow manufacturers to submit devices for de novo classification at the same time as they are submitted for 510(k) approval. FDA_logo.jpg

This move could shorten the approval process by as many as 90 days, according to a news release. Under the present framework, devices must be rejected for 510(k) approval before they can be submitted for the de novo process. 

“Right now, the de novo process is cumbersome and requires extra work and effort from manufacturers and the agency,” CDRH director Jeffrey Shuren said in the release. “Creating a pathway for a concurrent 510(k) and de novo petition streamlines the de novo program, helping speed safe and effective devices to patients.”

The de novo program is for "low- and moderate-risk devices" that do not have a predicate device and thus can't be approved through the 510(k) process. 

In response to the draft guidance, Janet Trunzo, executive vice president for technology and regulatory affairs for AdvaMed released a statement supporting optimizing the de novo pathway. 

From the statement:

AdvaMed is concerned that, if the de novo process is not streamlined, these low- to moderate-risk devices will not be marketed in the U.S. because the current de novo process takes too long, and the PMA process is inappropriate for these devices.

Medical technology manufacturers are particularly frustrated with the current process’ requirement that a 510(k) must be submitted and receive a “not substantially equivalent” (NSE) determination before a de novo classification can be requested. FDA’s proposed option for a “one-step” process in addition to the current two-step process – with the manufacturer having the choice of pursuing either the one-step or two-step process – may be a good start to streamlining the de novo process.

We believe the under-utilized de novo process has the potential to play a key role in the regulation of medical devices lacking a predicate for which general or special controls provide a reasonable assurance of safety and effectiveness. We look forward to working with the agency to ensure the proposed guidance helps facilitate timely patient access to these devices and diagnostics.”

View the draft guidance, titled "Draft Guidance for Industry and Food and Drug Administration Staff - De Novo Classification Process (Evaluation of Automatic Class III Designation)," on the agency's Web site. FDA will accept comments on the document for 90 days. The AdvaMed statement is also available online.  

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