Revising Qsr To Be More Closely Aligned With Iso 13485: Proposed Guidance Development And Retrospective Review
- Updates from the Center for Devices and Radiological Health (CDRH)
- Prioritizing digital health: Five guidances on our FY2019 list focus on supporting continued innovation and safety in digital health
- Advancing device safety and security: addressing device-specific safety issues or promote visibility related to specific labeling or testing recommendation
- Offering more flexibility and options for premarket submissions
- Sustaining high-quality servicing, effective oversight, and handling uncertainty in devices