EMERGO SUMMARY OF KEY POINTS:

• US FDA has published performance goals for handling de novo medical device submissions.
• De novo user fees and performance goals were established under the Medical Device User Fee Amendments of 2017 (MDUFA IV).
• FDA has set a 150-day timeframe for review of de novo applications.

Now that the US Food and Drug Administration has begun assessing user fees for de novo medical device market applications, the agency has set new performance goals for reviews of these submissions.

New FDA guidance explains that under the Medical Device User Fee Amendments of 2017 (MDUFA IV), agency performance goals and timeframes for handling de novo submissions have been established for fiscal years 2018 to 2022. The guidance also lays out actions available to FDA reviewers once they receive de novo market application requests.

(FDA has also issued new guidance that includes frequently asked questions regarding de novo user fees.)

FDA options for handling de novo requests

Once FDA reviewers receive a de novo request from a medical device manufacturer, the agency may take one of several approaches.

First, the agency may issue a granting order for classification of the device in question. This order entails FDA issuing a letter to the de novo registrant stating that its product meets classification criteria for a Class I or Class II device, and authorizes the applicant to market the device in the US. A granting order for classification is a final regulatory action and stops the review clock.

Second, FDA may issue a declining order stating either that the device in question does not qualify for de novo classification, or that the device does qualify for such classification but the applicant has not properly demonstrated that the device meets de novo criteria. In either case, a declining order results classification of the device as Class III subject to Premarket Approval (PMA). Declining orders are also considered final actions that stop the review clock.

Third, FDA may request additional information (AI) in cases where device submissions do not provide adequate information needed to conduct regulatory reviews and determine de novo eligibility. AI requests put de novo reviews on hold and pause the review clock until FDA receives complete responses from applicants. Recipients have 180 days to reply to AI requests.

Finally, FDA may send a notice of withdrawal stating that the agency considers a de novo application to be withdrawn. Such notices are issued when an applicant does not provide a timely and/or complete response to an AI request, or when an applicant requests to withdraw its de novo application from FDA consideration. Notices of withdrawal are final actions that stop the review clock.

De novo review performance goals under MDUFA IV

Over the next four fiscal years, FDA has set the following performance goals for de novo requests:

• User fees for most de novo submissions
• Guidance covering de novo submission checklists
• One-tier MDUFA decision goals rather than review cycle goals for de novo submissions
• De novo applicants that have not received MDUFA decisions within 180 days of submission may request a discussion with FDA regarding outstanding issues holding up regulatory decisions

In terms of de novo review timeframes, FDA has set a 150-day review time target; the agency intends to review 50% of de novo submissions over its 2018 fiscal year within that timeframe, and complete 70% of de novo submissions within 150 days by its 2022 fiscal year.

Additional US medical device regulatory resources:

• US FDA consulting for medical device and IVD companies
• FDA medical device classification consulting
• Whitepaper: FDA regulations for novel and innovative medical devices
• Whitepaper: Understanding the FDA medical device classification system