The US Food and Drug Administration (FDA) has issued seven new or updated guidances offering advice to medical device makers on its user fee programs and how FDA and industry actions impact the performance goals set by the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV).
In its MDUFA IV commitments, FDA agreed to tighter timelines to reach decisions for most medical device submissions in exchange for increased user fees and the introduction of a new user fee program for de novo classification requests.
In addition to the seven, FDA has also updated another guidance on its pre-submission program for medical devices to reflect changes to the scheduling of pre-submission meetings and how quickly FDA is expected to provide feedback to device makers following a pre-submission meeting.
Four of the guidances provide information on the user fees FDA is authorized to collect under MDUFA for 510(k) submissions, premarket approval (PMA) and device biologics license (BLA) applications, de novo requests and 513(g) requests for information.
For each of those submissions and requests, the guidances lay out when fees are applicable, the relevant exceptions to the fees, the consequences of not paying the fees and the process to pay fees or request a refund from the agency.
Three of the four guidances are updates to earlier versions issued under MDUFA III to account for changes in the user fee program, while the guidance on user fees for de novo requests is being issued for the first time.
For de novo requests, FDA clarifies that most submissions will need to pay a user fee unless the submission relates to a device intended solely for pediatric use or the submission is being made by a state or federal entity and will not be commercially distributed.
Review Clock and Goals Guidances
Three other guidances define the actions that FDA and industry can take with regard to 510(k) submissions, PMAs and de novo requests, and how those actions impact FDA's review clock and MDUFA goals.
As with the user fee guidances, the action guidances for 510(k) submissions and PMAs have been updated from an earlier version issued under MDUFA III, while the de novo guidance is new.
Because there are still 510(k) and PMA submissions under review at FDA that were received during the MDUFA III period, the 510(k) and PMA action guidances include information on both MDUFA III and IV goals.
For de novo requests, FDA says there are three actions it can take on a submission: grant the request, decline it or request additional information from the sponsor. FDA also clarifies that it considers a de novo request to be withdrawn if a sponsor does not respond to a request for additional information within 180 days.
According to FDA, both decisions to grant or decline a de novo request are considered final actions that shut off its review clock, while requests for additional information stop the agency's review clock until the sponsor provides the requested information to FDA.
User Fee Guidances:
User Fees and Refunds for Premarket Notification Submissions (510(k)s)
User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications
User Fees and Refunds for De Novo Classification Requests
User Fees for 513(g) Requests for Information
FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals
FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals
FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals
Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff