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Final guidance on reducing cross-contamination from irrigation valves and accessories for flexible gastrointestinal endoscopes adds a new section on testing for backflow prevention. Read More
Valeant received a warning letter for a high-precision compounding and dispensing device used to mix two solutions following an inspection that revealed a failure to maintain procedures for validating the device design. Read More
The International Organization for Standardization has released a standard that specifies design and performance requirements of small-bore Luer connectors used in intravascular applications or hypodermic connections in medical devices and accessories. Read More
A response to a Form 483 is not a routine or informal communication and should be given the same attention and care you would give to defending your company from a federal indictment — because that’s what a 483 actually is. Read More
PhotoMedex Inc. did not submit medical device reports (MDRs) in a timely manner, conduct an inadequate risk analysis, or establish adequate procedures for design change and corrective action, an FDA investigator reported on a Form 483. Read More
Epimed International Inc. was cited in a Form 483 for inadequate procedures for handling of complaints, design validation, design transfer, control over products, services and suppliers, and accepting incoming products at its Johnstown, N.Y. facility. Read More