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The FDA issued Revolutionary Science a Form 483 for documentation issues involving design changes, nonconforming product and in-process testing observed during an inspection of its Shafer, Minn., facility in April. Read More
The UK’s National Institute for Health and Care Excellence (NICE) is inviting comments on its first draft recommendation for a diagnostic device — AliveCor’s KardiaMobile 6L heart monitor — under a new fast-track review program called the Early Value Assessment pilot project. Read More
The test first received FDA approval in April 2021 for assessing the eligibility of patients with endometrial cancer for treatment with GSK’s Jemperli. Read More
Medtronic has released a software update to address the issue, but patients will need to do an in-clinic visit for the update to be installed. Read More
Process validation, according to the FDA’s Quality System Regulation (QSR), means “establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.” In other words: If a devicemaker cannot verify, by inspection or test, that each product specification has been met, the process itself must be tested, to ensure that it yields consistent results. Read More
The FDA handed Elite-Medical a Form 483 for problems with control of nonconforming products and a supplier issue observed during an inspection of its Florence, Ala., facility in April. Read More
The UK’s Department of Health and Social Care is seeking information for an independent review of the potential ethnic bias of certain medical devices such as oximeters and infrared scanners. Read More