Publications

5 Oct 2011

FDA issues draft guidance for device manufacturers: meaningful change or de novo review all over again?

FDA Alert

Kimberly K. Egan
Rebecca Jones McKnight
So-Eun Lee

This week, FDA issued draft guidance proposing a modified, streamlined approach to the de novo review process.

The de novo process is the mechanism FDA uses to consider whether to clear certain innovative, low- to moderate-risk medical devices for the US market. Draft Guidance for Industry and Food and Drug Administration Staff – De Novo Classification Process (Evaluation of Automatic Class III Designation) is one of 25 action items listed in FDA's Plan of Action for Implementation of 510(k) and Science Recommendations announced earlier this year.  (See our prior discussion of this topic here.)

FDA divides medical devices into three classes – Class I, Class II, Class III.  Class I is reserved for the lowest risk devices and Class III for the highest.  If FDA finds that a manufacturer’s device is “Not Substantially Equivalent” (NSE) to an existing device not subject to premarket approval (PMA) requirements (typically Class I or II), then it gives the device an automatic Class III designation.^[i]  If FDA has never classified a device of the same type as the one under consideration, once a manufacturer has a received an NSE letter, it can then submit a “de novo” application and ask FDA to re-classify the device into Class I or II instead of leaving it in Class III.^[ii] 

Previously, the formalities and uncertainties associated with the de novo process resulted – according to FDA – in underutilization of the process.  Although FDA encouraged applicants to consult with the agency about the likelihood a device could reach the market via the de novo process, this consultation was informal.  Also, even if FDA agreed the device was suited to the de novo process, applicants still had to wait for their NSE letter before they could proceed with a de novo petition.

"In theory there is no difference between theory and practice.  In practice there is." –Yogi Berra

FDA now proposes, in the draft guidance, to permit manufacturers to proceed with the substantial equivalence submission (known as the 510(k) process) and the de novo application at the same time. 

FDA contemplates that manufacturers would submit a Pre De Novo Submission (PDS) to allow FDA to formally assess early on whether the new device warrants a de novo application and, if so, what sort of performance and clinical data FDA would like to see in the petition.^[iii] FDA anticipates that the PDS would contain information sufficient to enable the agency to provide guidance on the test methods and protocols to be used for the collection of performance data.^[iv]

Once it receives the PDS, FDA would determine whether a likely predicate device exists for the device.^[v]  If so, FDA would notify the manufacturer that it should proceed with the substantial equivalence submission, not the de novo application.^[vi]  If FDA were to determine that no predicate device exists, FDA would issue an NSE determination for the 510(k) and take up the manufacturer’s de novo application.^[vii]

A manufacturer would still be able to follow the standard de novo process, i.e., start with a 510(k) submission and proceed with a de novo application only if FDA issues an NSE determination. 

Comment period is open

FDA is requesting comments on its draft guidance by December 2, 2011.  

Please contact us if you would like to submit comments on the guidance, or if you would like more information about how this draft guidance affects your business.

Kimberly K. Egan

Rebecca Jones McKnight

So-Eun Lee 

^{[i]               21 U.S.C. § 360c(f)(1).}

^{[ii]               21 U.S.C. § 360c(f)(2).}

^{[iii]              Draft Guidance, at 6.}

^{[iv]              Id.}

^{[v]               Id. at 9–10.} 

^{[vi]              Id. at 10.}

^{[vii]             Id.}