A new guidance document released by the US Food and Drug Administration (FDA) is intended to clarify the types of communication used by FDA and industry during the review of medical device submissions ...

Efforts at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) to improve the medical device review process under the Medical Device User Fee Amendments of ...

The landscape of FDA medical device regulation has undergone a significant transformation. Today's regulatory environment presents both familiar challenges and entirely new complexities that device ...

Some scientists assigned double the number of new product applications for review Some deadlines for tobacco products will not be met and the start of new applications have been delayed, scientist ...