Class III. Not called for PMA.

Open a product code in the classification database and one field answers the question everyone asks first: Class I, II, or III. It does not answer a second, quieter question that a preamendment device raises on its own — whether FDA has ever actually required a premarket approval application for that device type. For a long list of Class III product codes, the honest answer, for decades, was no.

A grandfather clause with a review built into it

Section 515(b) of the FD&C Act — 21 U.S.C. 360e(b) — lets a device that was on the market before May 28, 1976 (or found substantially equivalent to one that was) keep moving through 510(k) premarket notification even after FDA classifies its type into Class III, right up until FDA issues a separate action requiring a PMA. Class III is the risk finding. The PMA requirement is a different, later legal step, and nothing obligates the two to arrive together.

The Safe Medical Devices Act of 1990 added Section 515(i) — 21 U.S.C. 360e(i) — to force the question: FDA had to order manufacturers of these still-uncalled Class III device types to submit a summary of their own safety and effectiveness information, then decide, type by type, whether to reclassify down or keep the device in Class III and set a schedule for requiring a PMA. As of August 1995, FDA counted 116 preamendment Class III device types still waiting on that decision — nine had final PMA-required rules, ten had proposed ones, and the rest had neither.

Rulemaking became an order. The order still has to land.

Section 608(b) of the 2012 FDA Safety and Innovation Act changed how that final step gets taken: requiring a PMA for one of these legacy device types no longer needs full notice-and-comment rulemaking, just an administrative order. The mechanism got faster. It still has to be used, device type by device type, and most of the backlog predates the faster tool.

The clearest recent example closed a pathway outright. FDA’s final order on metal-on-metal semi-constrained total hip replacement systems took effect February 18, 2016, giving manufacturers until May 18, 2016 to file a PMA for devices they wanted to keep marketing. None has ever been approved. A device type that cleared through 510(k)s for decades, carrying the same Class III label the whole time, is not legally marketed today — and the label never changed. The order did.

Class III says FDA found the risk. It doesn’t say FDA has finished deciding what to do about it.

The practice

A portfolio read off product codes and their class alone will miss this every time, because the classification record isn’t wrong — it is just narrower than it looks. A Class III product code with a long 510(k) history is not evidence that a PMA will never be required; it may only mean the order hasn’t been written yet. Reading the Federal Register for a 515(b) action against your own preamendment product codes, not just the classification field, is the only way to see it coming before the filing deadline does. This is regulatory intelligence about where that decision lives, never advice about whether any specific product code is next.