CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food ...

Commenting on its court win, the AMP said at the time: “If it had been left in place, the FDA’s Final Rule would have classified LDTs as medical devices, creating unwarranted regulatory ...

The Trump Administration has effectively ended the Biden Administration's attempt to regulate lab-developed tests,” TD Cowen ...

the mindset driven by regulations and best practices has not permeated the industry. Manufacturers and healthcare organizations using devices are both responsible for these lapses. The FDA’s ...

The breadth of medical devices in terms of safety, it’s enormous. You have a pacemaker on one end and a tongue depressor on the other, and then FDA has to figure out a regulatory scheme that ...

A new FDA artificial intelligence tool designed to streamline medical device reviews is faltering in its early rollout stages, raising concerns for agency staff and ethics experts about its ...

Exhibit 2: FDA-authorized breakthrough devices by regulatory pathway and class Source: Authors’ analysis. Market-authorized breakthrough devices are publicly listed on the FDA website ...

Regulation during a rapid proliferation of AI medical devices Following the rapid proliferation of these devices and ...

As AI technology evolves rapidly, the FDA is tackling the challenge of balancing innovation with patient safety, shaping regulations that ensure AI tools remain effective throughout their entire ...

However, the integration of AI into medical devices raises significant regulatory challenges. Ensuring that these ...