United States | Medical Devices
EMERGO SUMMARY OF KEY POINTS:
- US FDA draft guidance explains agency’s process for recognizing voluntary consensus standards used for medical device declarations of conformity.
- The guidance describes FDA’s process and criteria for determining complete or partial recognition or non-recognition of consensus standards.
The US Food and Drug Administration’s medical device regulatory division has issued new guidance clarifying how it recognizes and withdraws voluntary consensus standards.
FDA’s Center for Devices and Radiological Health (CDRH...
Source | Stewart Eisenhart
Sep 20, 2018