US FDA CDRH released its proposed Guidances list for 2021 last week
Pierre Mermet-Bouvier
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Pierre Mermet-Bouvier
eCOAs I Regulatory Affairs I Transparency I PMO I Regulatory Intelligence I Clinical Operations I Global and Transversal Teams I Process Improvement I Operational Excellence I Strategic Planning
Apologies, I was in vacation with limited time & limited internet connection last week ;-)
End of last week, US FDA FDA’s Center for Devices and Radiological Health (CDRH) published its Proposed Guidances for Fiscal Year 2021 (FY 2021).
CDRH is usually in advance of CDER & CBER for this planning publication.
CDRH is also working differently with a A-list & a B-list (both with a Final & Draft Guidance lists):
- A-list: Prioritized Guidance Documents that CDRH Intends to Publish in FY2021
- B-List: Guidance Documents that CDRH Intends to Publish, as Guidance Development Resources Permit in FY2021
Among both I can mention the following expected 4 Final Guidances that seems of special interest (at least to me):
- Safer Technologies Program for Medical Devices
- Clinical Decision Support Software
- Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)
- Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations
Stay tuned for CDER & CBER planned 2021 Guidances ;-)
https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2021-fy-2021