Medical devices

New framework clarifies review, labeling, and submission requirements for drug-related software and companion apps.

Medtech trade group outlines recs to improve Medicare’s proposed RAPID coverage pathway and accelerate access to FDA-authorized tech.

FDA commissioner nominee Heidi Overton defended vaccine safety while declining to take firm positions on mifepristone reviews.

The US Food and Drug Administration has granted clearance to Vitestro’s Aletta device, easing phlebotomist shortages.

CMS proposes RAPID device coverage pathway to sync evidence with FDA, shorten Medicare timelines, and boost early collaboration with manufacturers.

FDA sets FY 2027 medical device user fees, updating submission and registration costs under MDUFA V and outlining small business reductions.

The US Food and Drug Administration is consolidating key functions, updating reporting structures, and formalizing realignment to improve coordination.

The group urges Canadian government to address affordability, regulatory modernization, and supply-chain resilience.