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Choosing an FDA pathway

Almost every device reaches the US market by one of four routes. Which one is yours depends on three things: the device's class, whether a suitable predicate exists, and how much risk it carries.

Start with the classification

FDA sorts device types into Class I, II or III by risk, and each classified type has a product code and a regulation in 21 CFR Parts 862–892. The regulation says what the type is, its class, and whether it is exempt from premarket notification. The free classification lookup searches FDA's database. If no type fits, or two seem to, a 513(g) request asks FDA directly.

The four routes

• Exempt. Most Class I and some Class II types need no premarket submission. You still register your establishment, list the device, and follow the general controls, including the quality system rule unless the type is exempt from it too. The FY2027 establishment registration fee is $13,785.
• 510(k). The usual route for Class II. You show the device is substantially equivalent to a legally marketed predicate: the same intended use, and the same technological characteristics, or different ones that don't raise different questions of safety and effectiveness. FDA's review goal is 90 FDA days. FY2027 fee: $28,653 ($7,163 with small-business status). Traditional, Special or Abbreviated is a further choice.
• De Novo. For a new type of device with no valid predicate whose risks are low to moderate, so general and special controls can manage them. A grant creates a new classification regulation. Review goal 150 days; fee $191,020 ($47,755 small business). More on De Novo.
• PMA. For Class III: devices that support or sustain life, are of substantial importance in preventing impairment of health, or present a potential unreasonable risk. You show a reasonable assurance of safety and effectiveness, usually with clinical data. Fee $636,732 ($159,183 small business).

When the answer isn't obvious

Two cheap moves settle most doubt before you spend on testing. A Pre-Sub gets FDA's written feedback on your plan, with no user fee. The De Novo check and the Special 510(k) check walk through FDA's own criteria in a few questions.

Sources

• The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications (FDA guidance)
• De Novo Classification Process (FDA guidance)
• Medical Device User Fees (FDA)

General information, not regulatory advice. FDA decides every classification and submission; confirm your route with FDA (a Pre-Sub or a 513(g)) or a qualified regulatory professional. Fees and review goals are planning figures; check FDA's current schedule.

More: Traditional, Special or Abbreviated 510(k) · De Novo in plain terms · 513(g) requests in plain terms · Pre-Subs (Q-Submissions) in plain terms · The Breakthrough Devices Program