USA – Considerations for the Conduct of Clinical Trials of Medical Products During Major...
This guidance recommends approaches that sponsors of clinical trials of medical products can consider when there is a major disruption to clinical trial conduct...
USA – FDA guidances keep coming, new device harmonization plan, and more
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical...
UK – Medical devices: EU regulations for MDR and IVDR (Northern Ireland)
This guidance provides information on the EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).
From 1 January 2021 the Medicines and Healthcare...
USA – Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation...
This guidance provides information on how the Biological Evaluation of Medical Devices standards are incorporated into the Pilot Accreditation Scheme for Conformity Assessment Program...
Europe – Ongoing consultations under the PECP
This page lists the views provided by the in vitro diagnostics expert panel under the Performance Evaluation Consultation Procedure (PECP) according to Article 48(6)...
Europe – Factsheet for authorities in non-EU/EEA states on medical devices and in vitro...
In April 2017, the European Parliament and the Council adopted the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices...
International – IMDRF guidance updates thinking on personalized medical devices
The International Medical Device Regulators Forum (IMDRF) says personalized medical devices (PMD) come in three varieties that require different regulatory approaches. As certain technologies...
USA – FDA weight-loss device guidances address clinical and non-clinical studies
A decade in the making, the US Food and Drug Administration (FDA) has published two complementary draft guidances for sponsors developing weight-loss devices. The...
USA – FDA’s final breakthrough devices guidance now includes technologies that address health disparities
Final guidance on the US Food and Drug Administration breakthrough device program includes new language noting that the program now can be used to...
USA – FDA updates medical device biocompatibility guidance with exclusion list
The US Food and Drug Administration (FDA) has updated its guidance on biocompatibility issues medical device sponsors should consider in their premarket submissions. This...
