The pathway decides your evidence, your timeline and your fee. Here is how the three fit together, the FY2027 numbers, and the small business determination that cuts a 510(k) fee by three quarters.

Three questions settle the pathway. What class is the device? Is there a legally marketed predicate with the same intended use and comparable technology? If not, is the risk low or moderate enough that special controls can manage it? Answer those and the submission type, the evidence bar and the fee follow.

The three pathways

510(k). For Class II devices, and the few Class I devices not exempt, with a predicate. You demonstrate substantial equivalence: same intended use, and either the same technological characteristics or different ones that raise no new questions of safety and effectiveness. Bench testing usually carries it; clinical data is needed only where the differences demand it. FDA's MDUFA goal is a decision within 90 FDA days for 95 percent of submissions. Total calendar time runs longer because the clock stops while you answer questions; the draft MDUFA VI letter targets an average of 128 days in FY2028, stepping down to 112 by FY2032.

De Novo. For novel low to moderate risk devices with no predicate. You propose the classification and the special controls, and if FDA grants the request the device becomes a Class I or II device that can serve as a predicate for others. The goal is a decision within 150 FDA days for 90 percent of requests. Under the draft MDUFA VI letter, requests received after October 1, 2027 get an introduction meeting within the first 30 FDA days, and FDA gains a formal not-grantable letter to say no early.

PMA. For Class III devices: those that support or sustain life, are substantially important in preventing impairment, or present a potential unreasonable risk. You demonstrate reasonable assurance of safety and effectiveness with your own evidence, almost always including a clinical study under an IDE. The shared goal is a decision within 285 calendar days.

If you are not sure which class you are in, a 513(g) Request for Information gets you FDA's answer. It is not a Pre-Sub question.

What it costs in FY2027

The fee rates published on July 30, 2026 apply to submissions received October 1, 2026 through September 30, 2027:

  • 510(k): $28,653 standard, $7,163 small business.
  • De Novo: $191,020 standard, $47,755 small business.
  • Original PMA: $636,732 standard, $159,183 small business.
  • 513(g): $8,596 standard, $4,298 small business.
  • Establishment registration: $13,785, with no small business discount, waived only for firms with gross receipts of $1,000,000 or less.

This is MDUFA V's last year. The draft MDUFA VI commitment letter rewrites the fee base for FY2028, and the two prior reauthorizations moved the 510(k) fee 125 percent and 56 percent in a single year.

The small business determination

Small business status requires gross receipts or sales of no more than $100 million including affiliates, and FDA has to approve the determination before the submission goes in, not after. For a first-time filer that means filing the small business determination request weeks ahead of the submission date. On a 510(k) the difference is $7,163 against $28,653. On a De Novo it is $143,265.

The establishment registration fee is the line that hurts a pre-revenue company: due every year, no small business rate, and a waiver only at $1,000,000 or less in gross receipts.

Timelines that are not the review clock

The review goals above are FDA days. Your calendar has three other clocks on it. A Pre-Sub takes 70 days to written feedback and is worth running before any pathway that involves a De Novo or a clinical study. An Additional Information letter gives you 180 days to respond or the submission is withdrawn. And a Breakthrough Devices designation, if you qualify, adds sprint discussions and priority review but does not change the pathway.