Interpreting the FDA Guidance on Evaluating Sex-Specific Data in Medical Device Clinical Studies
The US Food and Drug Administration (FDA), through its Center for Devices and Radiological Health (CDRH) and Center for Biologics
Regulatory News
Global medical device regulatory updates and registration guides
EU Biocidal Product Authorisation and Treated Article Registration
The EU Biocidal Products Regulation (Regulation (EU) 528/2012), abbreviated EU BPR, has applied since 1 September 2013. It requires all
Finding Core Information on Predicate Devices on the FDA Website
Core information on predicate medical devices can be obtained systematically from the FDA website. Here is a detailed guide: 1.
FDA Medical Device Product Codes
The FDA medical device product code consists of three letters and is an important identifier of device type and product
How to Look Up US 21 CFR Regulations
21 CFR (Title 21 of the Code of Federal Regulations) is the core body of regulations of the US Food
Introduction to EU MDR Class IIa Products
The main EU legislation on medical device classification is the EU Medical Device Regulation (Regulation (EU) 2017/745, MDR), and the
Introduction to EU MDR Class IIb Products
The main EU legislation on medical device classification is the EU Medical Device Regulation (Regulation (EU) 2017/745, MDR), and the
EU RED Cybersecurity Requirements Soon to Become Mandatory
The European Commission has adopted a delegated act under the Radio Equipment Directive (RED – 2014/53/EU), Delegated Regulation (EU) 2022/30,
EU Safety Rules for Medical Device Apps on Online Platforms
Guidance MDCG 2025-4, published by the EU Medical Device Coordination Group in June 2025, provides guidance on the safety of
FDA Registration (Part 8): The eSTAR for FDA 510(k) Submissions Explained
eSTAR (electronic Submission Template And Resource) is the FDA’s electronic submission template tool for medical device 510(k) submissions. It is