FDA has issued draft guidance on the de novo device classification process, indicating that the agency will allow manufacturers to submit devices for de novo classification at the same time as they ...

Sixteen days after the closing ceremony of the Olympics, Japan is hosting its next global sporting event as the Tokyo 2020 Paralympic Games get underway. Like the Olympics, the Paralympics are taking ...

The Sensible Classification Act would codify classification authority, streamline declassification, invest in new technology for classification reviews and require an evaluation of existing security.

On October 3, 2011, FDA issued a draft guidance entitled, “De Novo Classification Process (Evaluation of Automatic Class III Designation).” In the guidance, FDA described the submission and review of ...