Understand the 510(k) process under MDUFA, including timelines, fees, and cost drivers, and learn proactive strategies—like pre-sub meetings and complete testing—to streamline clearance and avoid unnecessary delays.
Effective planning requires understanding both the regulatory timeline and the associated costs. Under the Medical Device User Fee Amendments (MDUFA), the FDA sets performance goals for 510(k) reviews. A typical 510(k) follows three phases: acceptance review, substantive review and decision.
During the acceptance review, which occurs within 15 calendar days, the FDA verifies that the submission meets the Refuse to Accept criteria. Incomplete submissions are rejected and returned. If accepted, the substantive review phase begins, during which the lead reviewer and experts evaluate the scientific content. This phase lasts up to 60 FDA days, although the clock pauses during interactive review and AI holds. The FDA’s goal is to issue a decision within 90 FDA days (excluding hold time), resulting in a finding of Substantially Equivalent (SE) or Not Substantially Equivalent (NSE). Including time spent preparing responses to AI requests and performing additional testing, the average time to clearance is approximately 125 days.
The timeline can extend if your submission is complex, if testing is incomplete or if predicate selection is questionable. Pre‑submission meetings reduce unexpected questions and shorten review cycles. Responding promptly to AI requests and maintaining open communication with the reviewer also prevents delays.
MDUFA requires a fee for each 510(k). For fiscal year 2025 the standard fee is $24,335, while qualified small businesses pay $6,084. Small businesses must apply for fee reductions by demonstrating annual revenues below $100 million. There is no fee when a 510(k) is reviewed by an FDA‑accredited third‑party reviewer. In addition to user fees, companies incur costs for verification and validation testing, biocompatibility studies, consulting services and quality system improvements. Plan for these expenses early to avoid budget surprises.
Engage with the FDA early through pre‑submission meetings to confirm classification and testing requirements. Use the RTA checklist and eSTAR template to avoid administrative rejections. Ensure all testing is complete before submission. Consider third‑party review for low‑risk devices; these reviews often result in faster clearance and no FDA fee. Maintain a robust quality system to minimize the need for remediation.
By understanding the 510(k) timeline and fees, and by planning verification testing and budgeting accordingly, you can allocate resources wisely and avoid costly delays. A proactive approach—including pre‑sub discussions and thorough documentation—will help you achieve clearance efficiently.
