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 ...

Nearly a year and a half after first announcing an experimental pilot program that would allow its medical device review staff to better understand how the regulatory process occurs from the ...

The Food and Drug Administration is proposing to pre-certify vendors of certain medical device software, including various mobile apps, allowing the companies to skip the agency's much more rigorous ...

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 ...

Federal health officials are proposing a plan that would speed up the approval of innovative medical devices that have the potential to dramatically improve patients’ lives. The so-called Innovation ...