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The quality systems requirements the FDA is now mandating for drugs and biologics have been in place for the medical device industry since 1997, according to experts speaking at the recent Compliance Boot Camp in Las Vegas.
The FDA is now imposing the quality systems thinking that has been a staple of the medical device industry since 1997 on manufacturers of drugs and biologics, according to experts speaking at the recent Compliance Boot Camp in Las Vegas.
Device manufacturers must tap the right number of subject matter experts (SMEs) when developing the company’s standard operating procedures (SOPs), according to an industry executive who warned this decision can be the hardest part of implementing an SOP.
The FDA’s Center for Devices and Radiological Health released a question-and-answer guidance document intended to clarify how 21 CFR Part 820 of the quality system (QS) regulation applies to software maintenance activities for networked medical devices.
The FDA sent a warning letter to an Alabama dental device manufacturer after an agency investigator uncovered several significant quality system (QS) regulation violations.
Fischer Industries, a maker of X-ray film processors, recently received a warning letter from the FDA citing failures to keep records of device corrections or removals.
The FDA issued a warning letter to Alabama-based devicemaker Wilson Instruments for Medicine last month after inspectors determined that the firm failed to implement numerous quality control procedures.
The FDA recently issued a warning letter to Richardson, Texas-based dental products firm Dale Dental for a multitude of current good manufacturing practice violations.
Companies that manufacture single-entity or co-packaged combination products must adhere to manufacturing regulations governing both pharmaceutical products and medical devices, according to a draft guidance released Sept. 29 as part of the FDA’s pharmaceutical cGMP initiative.