FDA Cuts Red Tape for Cancer Gene Tests, Patients Rejoice
Published Date: 11/25/2025
Proposed Rule
Summary
The FDA wants to change the rules for certain cancer-related genetic test systems, making them easier to get approved by moving them from a strict Class III to a more flexible Class II category. This affects companies making these tests and could speed up how quickly patients get access to important cancer treatments. Comments on this change are open until January 26, 2026, so now’s the time to speak up!
Analyzed Economic Effects
4 provisions identified: 3 benefits, 1 costs, 0 mixed.
Class III → Class II: 510(k) Instead of PMA
The FDA proposes to reclassify certain nucleic acid-based oncology test systems (product codes OWD, PJG, PQP, and SFL) from Class III (PMA) to Class II (special controls). If finalized, manufacturers would no longer need a Premarket Approval (PMA) but must submit a premarket notification (510(k)) before marketing these devices.
Faster Patient Access to Cancer Tests
FDA says reclassifying these oncology nucleic acid-based test systems to Class II and using the 510(k) pathway may result in shorter premarket review timelines and enable more manufacturers to develop these tests, which could provide more timely access to tests that guide cancer treatment decisions.
Use of Predetermined Change Control Plans
Manufacturers may use FDA-authorized predetermined change control plans (PCCPs) to implement future modifications described in an approved PCCP without submitting a new 510(k) or PMA supplement for each change, under section 515C of the FD&C Act (FDORA, enacted December 29, 2022).
Prescription IVD Labeling Requirement
If reclassified to Class II, these devices will be identified as prescription in vitro diagnostics (IVDs) and will be subject to prescription labeling requirements for IVD products (see 21 CFR 809.10(a)(4) and (b)(5)(ii)).
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Key Dates
Department and Agencies
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