US FDA Recommendations for Voluntary Recalls of Medical Devices and Products
Final guidance from US FDA covers how manufacturers and distributors should develop and initiate voluntary recalls of products including medical devices, IVDs and pharmaceuticals. Learn more at Emergo by UL.
Brazilian Regulators Update Economic Monitoring Requirements for Some Medical Devices
Brazilian medical device regulator ANVISA has issued new regulations regarding economic monitoring of certain device types in order to boost transparency and establish reference pricing for these products.
European Regulators Publish New Q&A on Custom-Made Medical Devices
Manufacturers of custom-made medical devices (CMD) have a new FAQ resource for MDR compliance from the European commission's medical device coordinating group, or MDCG. Learn more at Emergo by UL.
Singapore HSA Explains New Developments for COVID-19 Test Kit Authorizations
The Singapore health sciences authority (HSA) announced that it is no longer accepting provisional authorization (PA) applications for COVID-19 test kits.
US FDA Revokes Emergency Use Authorizations (EUA) for Some Personal Protective Equipment (PPE)
US regulators have revoked emergency use authorizations for some non-NIOSH-approved personal protective equipment (PPE) as the country's COVID-19 public health emergency situation evolves. Learn more at Emergo by UL.
New Notified Body Designated to IVD Directive in Europe
A second Polish Notified Body, CeCert, has been designated under the European In-Vitro Diagnostic Medical Devices Directive (IVDD).
European Commission Offers New Guidance on Medical Device Standards Development
European Commission group provides new guidance on current and future approaches to medical device standards harmonization and development.
European Commission Issues MDR Q&A Document on Medical Device Clinical Investigations
The European MDCG has issued new guidelines for compliance to clinical investigation requirements under the medical devices regulation (MDR). Learn more at Emergo by UL.
US FDA Publishes Draft Guidance on Distinguishing Between Servicing and Remanufacturing Devices
The document addresses maintenance activities performed on products that have the potential to impact their regulatory status.
US FDA Removes Some Software Functions from Medical Device Classification Regulations
The US food and drug administration adjusted the language in eight medical device classification regulations in a ruling published in the federal register.