The FDA has released seven new, or updated, guidance documents relating to its user fee programs and performance goals outlined in the fourth version of the Medical Device User Fee Amendments.
In MDUFA IV, FDA agreed to accelerate approval decisions for most medical device submissions. In exchange, user fees were bumped up and a new user fee program was introduced for de novo applications.
Four of the guidance documents issued by the FDA deal with the user fees that FDA will collect for 510(k) submissions, premarket approval and device biologics license applications, 513(g) requests for information and de novo requests.
The guidance documents describe when the fees are applicable and when there are exceptions, as well as how to pay fees or request a refund.
The FDA also told medical device companies through these guidance documents that for de novo requests, most submissions will require a user fee – unless the submission relates to a device intended solely for use in the pediatrics arena. There is also an exception made for states or federal entities submitting a request for a device that will not be commercially distributed.
For example, FDA wrote that there are three actions it can take regarding a de novo request: grant the request, decline it or ask for more information from the sponsor.
The regulatory agency also added that if a sponsor doesn’t respond to a request for more information, it considers the de novo request to be withdrawn.
The guidance documents also clarify that decisions to grant or decline a de novo request are considered final actions and will stop the agency’s review clock. A request for more information will stop the FDA’s review clock until the sponsor gives the additional information over to FDA.