Topic archive
MedTech Current publications and recall entries tagged TSCA.
EPA has announced the availability of a draft TSCA risk evaluation for 1,2-dichloropropane and is accepting public comments through November 3, 2026. The draft preliminarily identifies unreasonable risk to human health under certain conditions of use; it is an evaluation step, not a final restriction or ban.
EPA has released a draft TSCA risk evaluation for trans-1,2-dichloroethylene, preliminarily finding that the chemical presents an unreasonable risk to human health driven primarily by certain conditions of use, and is accepting public comment through October 26, 2026. For medical-device-related manufacturers, the practical near-term question is whether the substance appears in cleaning, degreasing, formulation, or supplier processes that may later be affected by TSCA section 6 risk-management activity.
EPA has finalized Significant New Use Rules for a batch of PMN chemicals already subject to TSCA section 5(e) Orders, with the rule taking effect on 26 October 2026. Manufacturers, importers, and processors planning a designated significant new use must submit a SNUN at least 90 days in advance and may not begin the activity until EPA completes its review and takes the actions required by its determination.
EPA has published its May 2026 TSCA Section 5 statements of findings for certain new-chemical and significant-new-use submissions determined not likely to present an unreasonable risk under the reviewed conditions of use. The notice is not a new medical-device restriction, but it can be useful upstream intelligence when suppliers introduce new polymers, additives, coatings, or other chemical inputs.