24 October 2018 Uploaded a new version of the 'A guide to what is a medicinal product' document. Contents . This guidance applies to manufacturers of class I medical devices, including accessories but excluding devices intended for … FDA recommends that wireless medical devices utilize wireless protection (e.g., wireless encryption,6 data access controls, secrecy of the “keys” used to secure messages) at a level appropriate for the risks presented by the medical device, its environment of use, the type and probability of the risks to which it is exposed, and the probable risks to patients from a security breach. Last week, FDA released guidance for life sciences manufacturers that produce medical devices and components “critical to public health,” including materials that support or sustain life, or are used in emergency care or surgery. Recently, the US Food and Drug Administration (“FDA”) Center for Devices and Radiological Health (“CDRH”) published guidance describing how medical device manufacturers should notify CDRH of shortages during the pandemic. The Guidance is intended to facilitate timely disclosures to FDA and help the Agency prevent or mitigate any potential medical device shortages during the COVID-19 health emergency. Guidance on class 1 medical devices. The Guidance clarifies and makes recommendations regarding three major notification requirements: (1) who must notify FDA, (2) when to notify FDA, and (3) what information to include in notifications. Regulatory guidance for medical devices Check the legal requirements you need to meet before you can place a medical device on the market and … This guidance is primarily aimed at manufacturers of all device classes and developers of medical devices and drug-device combination products, and … Guidance Off-label use of a medical device Published 18 December 2014. This is a new reporting requirement for medical device manufacturers, as they are generally not required to report shortages.

Added a link to new guidance on medical devices regulation in a no deal scenario.