FDA Eases Rules for Cancer Tests to Speed Patient Access
Published Date: 6/11/2025
Proposed Rule
Summary
The FDA is changing the rules for certain cancer test kits called in situ hybridization (ISH) systems, making them easier to get approved by moving them from a strict category (class III) to a less strict one (class II). This means companies can bring these tests to market faster, but they still have to meet safety and quality checks. This update helps patients get important cancer treatments sooner without extra costs or delays.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
ISH Cancer Tests Reclassified to Class II
The FDA proposes to reclassify in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK) from class III (premarket approval) to class II (special controls). These devices would become subject to premarket notification instead of premarket approval, which the agency says enables companies to bring the tests to market faster and may speed patient access to the corresponding oncology treatments.
New Special Controls and Premarket Rules
FDA is proposing a new device classification regulation that sets out the special controls manufacturers must meet to provide a reasonable assurance of safety and effectiveness for these ISH test systems. Manufacturers would need to meet those special controls while using the class II pathway and premarket notification process.
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