USA – Convergence: Tips for when to include PCCPs in product submissions
The US Food and Drug Administration (FDA) sees predetermined change control plans (PCCPs) as a way to improve medical device innovation in the country,...
USA – Patient preference information: Researchers offer insights on medical device clinical trial design
The US Food and Drug Administration (FDA) has increasingly called for the inclusion of patient preference information (PPI) to inform its regulatory decision-making for...
Europe – Best Practice Guidance for the Submission of Technical Documentation under Annex...
This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual...
France – La Société française de dermatologie appelle les autorités à réglementer l’usage de...
PARIS (TICpharma) - La Société française de dermatologie (SFD) et son groupe de télédermatologie et e-santé (Teldes) a appelé les autorités de santé à...
Europe – Manual on borderline and classification for medical devices under Regulation (EU) 2017/745...
Determining whether a given product falls under the definition of a medical device and the
application of the classification rules fall within the competence of...
Europe – 37 ème organisme notifié au titre du Règlement 2017/745
37 ème organisme notifié au titre du Règlement 2017/745
USA – EPA proposes rules on EtO with implications for medical device sterilization
The US Environmental Protection Agency (EPA) has proposed two much-anticipated rules that would restrict how much ethylene oxide (also referred to as EO or...
Europe – MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products :...
The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR (medical device regulation), provides a possibility to use clinical data related...
USA – New FDA guidance offers ethical roadmap for including children in clinical trials
The US Food and Drug Administration (FDA) has issued draft guidance outlining a series of ethical considerations for conducting clinical trials that involve children.
The guidance,...
USA – FDA device center guidance priority lists targets COVID, digital health
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has published its FY2023 guidance priority lists. Much of the...
