MDUFA Performance Goals and Processing of 510k Submissions
This guidance describes FDA actions and industry actions that may be taken on premarket notifications (510(k)s), and their effects on review goals under MDUFA IV (FY 2018-2022) and MDUFA V (FY 2023-2027). It outlines the review process, timelines, and performance goals for 510(k) submissions.
Recommended Actions
- Ensure payment of appropriate user fees before submission
- Prepare complete eCopy or eSTAR submission package
- Monitor review timelines and be prepared for:
- Acceptance Review response within 15 days
- Substantive Interaction around 60 days
- MDUFA decision target of 90 FDA days
- Plan to respond to any Additional Information requests within 180 calendar days
- Maintain active communication with FDA during Interactive Review process
- Track submission status against MDUFA performance goals
- Be prepared for potential Missed MDUFA Decision communication if review exceeds 100 FDA days
- Consider withdrawal strategy if unable to meet response timelines
Key Considerations
Software
- eSTAR submissions are not subject to Refuse to Accept (RTA) process but undergo technical screening within 15 calendar days
- All 510(k) submissions need a valid eCopy or electronic submission to initiate review
Other considerations
- Most 510(k) submissions are subject to user fees
- Acceptance Review conducted within 15 calendar days of receipt
- Substantive Interaction within 60 calendar days for accepted submissions
- MDUFA decision goal (SE/NSE) of 90 FDA days with 95% performance level
- Total Time to Decision goals ranging from 128 to 112 calendar days during MDUFA V
- Maximum 180 calendar days allowed to respond to Additional Information requests
- Missed MDUFA Decision communication if no decision within 100 FDA days
Relevant Guidances
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Electronic Submission Template And Resource (eSTAR) for 510k Submissions
- User Fees and Refunds for 510k Submissions
- Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
Related references and norms
- 21 CFR 807: Electronic Code of Federal Regulations - Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices
Original guidance
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