You may wonder why I would post about CDRH activities. Since they are involved in approving devices and assays/tests for clinical laboratories (i.e., biomarker tests), they play an important part in delivering medical care to patients.
From the announcement:
The FDA’s Center for Devices and Radiological Health (CDRH) released its 2022 Annual Report to highlight the Center’s programmatic accomplishments through December 31, 2022, including the Pandemic Response, the Medical Device User Fee Amendment (MDUFA) V, Device Innovation, Over-the-Counter (OTC) Hearing Aid Final Rule, and Device Safety.
Topics covered in the report include:
- CDRH By the Numbers
- Pandemic Response
- COVID-19
- Mpox
- MDUFA V
- Device Innovation
- Novel Devices
- Upstream Innovation
- Expediting Premarket Submissions
- Marketing Authorizations for Novel Devices
- Digital Health
- OTC Hearing Aid Final Rule
- Device Safety
- Recalls
- Cybersecurity
- Material Safety
- Health of Women Strategic Plan
- Real World Evidence / Real World Data
No comments:
Post a Comment