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MDUFA VI: Why FDA Device Reviews Are Getting Tougher, Not Faster

FDA Device

There's a quiet hope that keeps circulating among medical device companies eyeing the US market.

"Maybe the next round of reforms will finally speed things up."

Application volume keeps climbing while the reviewer headcount stays flat, so the thinking goes that the next policy overhaul has to bring some relief.

The signal FDA just sent points the other way. Not faster. Tighter.



MDUFA Isn't Just a Fee Schedule — It's a Five-Year Deal Between FDA and Industry

Getting a device onto the US market means going through FDA review — 510(k), De Novo, or PMA. Those reviews come with user fees, and that fee revenue is what funds FDA's reviewer headcount and its commitment to hit certain processing-time targets. That deal gets renegotiated every five years under MDUFA, the Medical Device User Fee Amendments.

What FDA just released is the draft commitment letter for the sixth reauthorization — MDUFA VI, covering fiscal years 2028 through 2032. However this draft gets finalized will shape what device review looks like for Korean manufacturers submitting to the US for the next five years.



This Round Is Different — Not "Faster," but "More Consistent"

Past MDUFA reauthorizations have mostly pushed in one direction: faster reviews. This one reads differently. FDA officials recently said MDUFA VI won't focus on shortening review timelines further compared to MDUFA V — instead, the priority is improving consistency across the review process and boosting domestic prioritization.

Translation: it's not "we'll get to you quicker." It's "no matter which reviewer you draw, you'll be judged by the same standard, and you'll be able to predict what that standard is."



Why "Consistency" Isn't Purely Good News

Inconsistency has been a long-standing industry complaint. The same category of device can draw wildly different documentation requirements depending on who's reviewing it, and the threshold for triggering an Additional Information request has felt arbitrary from one reviewer to the next. On the surface, fixing that sounds like a win.

The catch is that "more consistency" tends to mean standards level up, not down, in practice. Looser reviewers get pulled toward the stricter end, not the other way around. So the real shift isn't a faster clock — it's a higher bar for what counts as a complete, review-ready submission from day one.



This Isn't Just an Industry Story


FDA Device

MDUFA negotiations also touch digital health, AI-enabled devices, and expanded use of real-world evidence. Think smartwatch ECG features, or AI tools that help read diagnostic imaging — the everyday tech that reaches consumers depends on how fast, and how safely, FDA lets these devices through.

Reviews that are too loose let unvetted products onto the market. Reviews that are too rigid keep genuinely useful innovation from reaching patients on time. MDUFA is the five-year exercise in finding that balance point.



What Korean Manufacturers Should Take From This


  • Drop the assumption that things will speed up. 

    Even if this negotiation goes through as drafted, the more likely outcome is a higher bar for documentation quality — not a shorter clock. Plan around that.

  • Pay close attention to the AI and real-world evidence provisions. 

    The draft signals FDA's intent to expand support for AI-based technology and real-world evidence use. If you're bringing a device with embedded AI software, or planning to expand indications using post-market data, how these provisions get finalized will directly affect your submission strategy.

  • None of this is law yet. 

    The public meeting and written comment period on the draft commitment letter have already wrapped, but formal legislation is still further out. That said, the "consistency over speed" direction already looks fairly locked in internally at FDA.



The message behind MDUFA VI is pretty clear: not "we'll rush it through," but "we'll take our time and hold everyone to the same bar." Rather than counting on a lenient reviewer, the safer bet is building a submission solid enough to clear review regardless of who's assigned to it.

Worth checking now: is the documentation you're preparing "reviewer-proof"?




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