FDA has issued white papers detailing sterility testing essentials for medical device makers. The papers present concepts and problems associated with sterility testing and review different testing methodologies.

"For medical device manufacturers, testing of medical devices is required during the sterilization process as well as for routine quality control. Understanding sterility testing is essential when designing the validation process," FDA says.
"The need to provide adequate and reliable test data is an important quality control issue," the agency says. "False positive results and test failures can have significant impact on production schedules and device time-to market."

The information is available for free download from Microtest at http://www.microtestlabs.com

Source: PR Newswire