Many Medtech startups view FDA and similar regulatory bodies as a roadblock. Something that is there to get in their way, slow them down, and cost them a fortune. Smart companies see regulations as an ...

The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...

Regulatory Focus is the only source of timely, quality news and information fully dedicated to daily online coverage of the global regulation of healthcare products. An experienced team of reporters ...

Jeremiah Kelly and Justin Coen joined Faegre Drinker as partners in its government and regulatory affairs practice in Washington, DC, the firm announced Wednesday.

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...

As promised in its FDASIA report, the FDA has published a draft guidance document that aims to help those creating wellness devices and apps to better understand when their product (or their marketing ...

Health regulators on both sides of the Atlantic are assessing alignment opportunities and exploring mutual recognition ...

How do companies move away from making costly errors during FDA inspections? That’s the question Michael Drues, president at Vascular Sciences and an independent regulatory and quality consultant, ...

CorTec GmbH, a pioneer in fully implantable brain-computer interfaces (BCI), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the ...

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Medline Industries, citing serious concerns over ...