28/29 September 2022
In the USA, medical devices are regulated within the FDA by the Center for Devices and Radiological Health (CDRH). How can one quickly familiarize oneself with the topic of "medical devices" or stay up to date? The FDA offers a separate website for this purpose: CDRH Learn.
The information is very comprehensive, starting with basics on the regulatory framework for medical devices (the slides were recently revised in April 2019), fee requirements, UDI, registration questions (site and product), marketing authorisation questions and requirements for monitoring during the marketing phase ( post-market activities). Generally, presentations, slides and a presentation protocol are available. Under the heading "Postmarket Activities", you can also find information on typical elements of the QM system, such as design controls, process validation, CAPAs and complaints.
All information can be found on the FDA website CDRH Learn