Search
Sharan Murugan
- May 25
- 2 min
EMA Med Dev. Guidance: New Guidance for Industry and Notified Bodies
The European Medicines Agency (EMA) has recently released updated Q&A guidelines "New Guidance for Industry and Notified Bodies" that...
20 views0 comments
Sharan Murugan
- May 6
- 2 min
USFDA MD Guidance: Enforcement Policies for Tests During a Section 564 Declared Emergency & for Certain In Vitro Diagnostic Devices
Today (06 May 2024) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released two draft guidances...
10 views0 comments
Sharan Murugan
- Apr 20
- 2 min
MDCG Guidance: In-Vitro Diagnostic Medical Device Safety Reporting
The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Safety reporting in performance studies of...
8 views0 comments
Sharan Murugan
- Jul 17, 2023
- 1 min
MHRA Med Dev Guidance: In-Vitro Diagnostic Medical Devices on Legislation
Earlier today (17 July, 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The...
23 views0 comments
Sharan Murugan
- Jun 20, 2023
- 1 min
USFDA Guidance: Pilot Program Oncology Drug Products & In Vitro Diagnostic Tests
Earlier today (20 June, 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health, Center for Drug...
19 views0 comments