MD&M East

Guidance on Device Classification Product Codes

FDA has finalized guidance on medical device classification product codes that are used to assist in accurate identification and tracking of current medical devices, and for easy reference to ...
RAPS

FDA Finalizes Guidance on Device Classification Procedures

The US Food and Drug Administration (FDA) has released a new guidance document finalizing its recommendations for the medical device industry on how to use Classification Product Codes (CPC), a ...
RAPS

New MDCG guidance shows how devices fit into MDR’s classification rules

The European Commission’s Medical Devices Coordinating Group (MDCG) on Monday issued a guidance to help manufacturers classify their devices under the Medical Device Regulations (MDR) before they are ...
JD Supra

Call for comments: FDA wants feedback on the distinct classification of existing device accessories into Class I

FDA's Center for Devices and Radiological Health (CDRH) issued a request for public comment on December 5, 2025, seeking feedback on the distinct classification of existing medical device accessories ...
MD&M East

Guidance on Making Benefit-Risk Determinations

CDRH has issued a first-of-a-kind guidance: "Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications [PDF link]." The guidance ...