The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...

The Final Q-Sub Guidance provides comprehensive guidance on the Q-Sub process and finalizes the draft guidance regarding the Q-Sub program that was issued on March 15, 2024, with minimal changes from ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

The FDA formally kicked off its quinquennial process to reauthorize the federal user fee legislation that helps fund its medical device reviews by hosting discussions with the medtech industry and ...

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

The Food and Drug Administration plans to select about 40 devices not yet cleared by the agency to receive special agency discretion to participate in the new chronic care Advancing Chronic Care with ...

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device clearances. That includes the Jan. 17 green light of Myocene’s neuromuscular ...

To wrap up an already complicated 2025 for medtech, FDA has lost two major leaders in the digital and medical device space. According to sources, Jessica Paulsen, acting deputy director of FDA’s ...

From 2007 through 2017, 98.1 percent of recalled foot and ankle devices had approved through the FDA 510(k) premarket approval, according to a study published in the Cureus Journal of Medical Science.