Last week, the U.S. Food and Drug Administration (FDA) finalized guidance on the types of information that should be included in a Predetermined Change Control Plan (PCCP) as part of a marketing submission for an artificial...more
For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions....more
The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary alternative pathway for new, moderate-risk devices for use in...more