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.
What You Need to Know? 👇
What are the key differences between MDUFA IV and MDUFA V performance goals for 510(k) submissions?
MDUFA V maintains the same 60-day Substantive Interaction and 90-day MDUFA decision goals as MDUFA IV, but adjusts the Total Time to Decision goals. MDUFA V also introduces automatic 180-day response periods for AI requests and requires Missed MDUFA Decision communications for delayed reviews.
How long do I have to respond to an FDA Additional Information (AI) request for my 510(k)?
You have 180 calendar days from the date FDA issues the AI request to submit a complete response. FDA automatically grants this extension without requiring a written request. Failure to respond within this timeframe results in withdrawal of your 510(k) submission.
What happens if my 510(k) submission uses eSTAR instead of traditional paper format?
eSTAR submissions bypass the Refuse to Accept (RTA) process and instead undergo technical screening within 15 calendar days. The review clock starts on the day FDA received your submission if it passes technical screening, potentially accelerating the overall review timeline.
When does FDA issue a Missed MDUFA Decision (MMD) communication?
FDA provides MMD communication for 510(k) submissions that don’t reach a MDUFA decision within 100 FDA days (10 calendar days after the 90-day goal). This communication includes outstanding review topics and estimated completion dates, discussed in a meeting or teleconference.
What constitutes a complete response to an FDA AI request?
A complete response must address all deficiencies identified in FDA’s AI request. If you don’t address all deficiencies, FDA will place your 510(k) back on hold from the original AI request date, and the review clock won’t resume until all issues are resolved.
Can I withdraw my 510(k) submission after receiving an AI request?
Yes, you can request withdrawal of your entire 510(k) submission at any time before FDA renders a final decision. The withdrawal stops the review clock immediately and marks the end of FDA review, considered a final action.
What You Need to Do 👇
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