Health Law Daily Wrap Up, REGULATION TRACKER—Information on pending or recently adopted regulations and regulation amendments, (Apr 6, 2026)

By WK Editorial Staff

This Health Law Regulation Tracker includes a Proposed Rules Comment Calendar and a Table of Final Rule Effective Dates.

New proposed rules. On March 30, 2026, the FDA proposed reclassification of Mycobacterium tuberculosis cell-mediated immunity tests and Mycobacterium tuberculosis cell- mediated immune response enzyme- linked immunospot tests intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection (product codes NCD and OJN, respectively), both of which are postamendments class III devices (premarket approval), into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices.

On April 1. the FDA filed a color additive petition, submitted by the International Association of Color Manufacturers (IACM or petitioner), proposing that we amend the color additive regulations to no longer provide for the use of three specified solvents (methylene chloride, trichloroethylene, and ethylene dichloride) for preparing certain color additives because these uses have been permanently abandoned.

See the Regulation Tracker for details.

New final rules.

On April 3, the DEA issued a final rule designating P2P methyl glycidic acid (2-methyl-3-phenyloxirane-2-carboxylic acid; BMK glycidic acid) and its esters, its optical and geometric isomers, its salts, salts of its optical and geometric isomers and its esters, and any combination thereof, as a list I chemical. This action subjects handlers of P2P methyl glycidic acid to the chemical regulatory provisions of the Controlled Substances Act (CSA) and its implementing regulations

See the Regulation Tracker for details.

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