College of American Pathologists Supports FDA’s Role In LDTs, Not Its Rule

The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.

An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.

Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.

The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.