We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Failure to establish and document finished device acceptance procedures and to adequately calibrate equipment were among the quality deviations that the FDA observed during a Sept. 15-21, 2020 inspection of Kenlor Industries’ Santa Ana, California facility. Read More
The European Commission’s Medical Device Coordination Group (MDCG) released guidance that clarifies expectations for notified bodies conducting remote audits during the COVID-19 pandemic. Read More
The UK and the European Union wrapped up a landmark trade deal on Dec. 24 — just days before the UK completed its transition out of the EU. Although not specifically targeted at medical devices, the pact acknowledges existing arrangements for devices. Read More
The FDA has released new guidance aimed at easing inspection requirements for mammography equipment, acknowledging the challenges facing facilities during the COVID-19 pandemic. Read More
The FDA continues to issue warning letters for unapproved products to treat or detect COVID-19 and said it is taking “urgent measures” to protect consumers from products that, without the agency’s approval or authorization, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. Read More
The FDA issued a warning letter to Batelle Memorial Institute in Columbus, Ohio, for its Critical Care Decontamination System, which received an Emergency Use Authorization on March 28. Read More
Combination product agreement meetings — known within the FDA as CPAMs — are a prime way sponsors of such products can gather agency feedback on their applications, the agency said in a final guidance released yesterday. Read More
The FDA issued final guidance for bioburden reduction systems that use dry heat to help support single-user reuse of certain particulate filtering facepiece respirators (FFRs) as the need for FFRs may outpace the supply available to healthcare organizations during the COVID-19 pandemic. Read More
Australia’s Therapeutic Goods Administration (TGA) released new regulatory requirements for personalized medical devices that will go into effect on Feb. 25, 2021. Read More
The European Commission’s Medical Device Coordination Group has released long-awaited guidance on how to classify products for compliance with the European Union’s In Vitro Diagnostic Regulation (EU IVDR). Read More