FDA publishes Lists of planned Medical Device Guidances 2023
In October 2022, the Center for Devices and Radiological Health (CDRH) published a list of new guidances planned for fiscal year 2023 (1 October 2022 - 30 September 2023), as well as older guidances to be reviewed for topicality. What is planned?
The FDA released the final guidance on Comparability Protocols for postapproval CMC changes. The revised guidance follows the draft version issued in April 2016.
Medical Device Warning Letter Statistics for Fiscal Year 2022
The ECA regularly analyses the deficiencies identified in FDA Warning Letters relating to medical devices. Since medical devices can also be part of a combination product of a medicinal product and a medical device, these statistics are also of interest to manufacturers of these products. What do the medical device Warning Letter statistics show for the 2022 fiscal year?
You could already read in the past about the FDA CDRH's website for medical devices. It provides you with the possibility to get familiar quickly with the topic "medical devices" or to stay up to date. What is new?
Medical Device Information available on EMA's Website
We have already reported about information regarding medical devices available on the EU Commission's website. Recently, a chapter on in vitro diagnostics (IVDs) was added. Also, the EMA website has a dedicated page for medical devices. What can be found there?
Great Britain plans a New "Mark" for Medical Products as a Replacement to the CE Mark
With UK's exit from the EU (Brexit), a transition period also started with regard to medical devices. The MHRA has now published plans on how to proceed after this transition period.
New FDA Draft Guidance "Cybersecurity in Medical Devices"
On 8 April 2022, the FDA published a new draft guidance "Cybersecurity in Medical Devices..." to replace the previous guidance from 2014. Why did the FDA publish this draft?
The FDA provides recommendations for sponsors, investigators, and other interested parties on the use of digital health technology for remote data acquisition in clinical trials. What is required regarding software validation and electronic documents?
CMDh: Adjustments to the Guide for Electronic Submissions (eAF)
A new version of the "Module 1: Administrative information Application form - User guide for the electronic application form for a Marketing Authorisation" was prepared in December 2021 and has now been published on the HMA (Heads of Medicines Agencies) website. This document is intended to serve as a supporting guide for the preparation of the electronic application form for the submission of medicinal products for human use and for the registration of traditional herbal medicinal products.
A very helpful source of information on the regulation of medical devices is the website of the EU Commission. This has now been restructured. How does the new structure look like?