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.
The China Food and Drug Administration (CFDA) has established a permanent medical device recall program that requires manufacturers’ quality management systems to include event monitoring. Read More
Rapid Release Technologies received a warning letter for failing to apply for premarket approval (PMA) or an investigational device exemption (IDE) for a massage device. Read More
Device manufacturers in China should integrate cybersecurity risk management into their quality management systems, according to new guidance from the China Food and Drug Administration. Read More
Former FDA deputy commissioner Scott Gottlieb emerged as the favorite to serve as the next leader of the FDA in a survey of 53 pharmaceutical companies. Read More
The FDA’s recently released final guidance on GMP requirements for combination products includes several compliance scenarios for prefilled syringes, drug-coated meshes and drug-eluting stents. Read More
The EU’s new medical device regulations nearing final approval will require more robust quality management systems, including the use of unique device identifiers and tighter control over distribution chains. Read More
Combining various risk metrics into a single number can help manufacturers rank suppliers according to risk and identify those that might need to be dropped. Read More
Best Medical Canada landed a Form 483 for not establishing adequate complaint procedures or ensuring that its devices conformed to specifications. Read More
The FDA has reclassified antigen-based rapid influenza virus antigen detection test systems (RIDTs) from Class I to Class II devices and has introduced special controls aimed at improving the quality of testing. Read More