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The FDA updated the status of a voluntary field removal notice for Penumbra’s 3D revascularization device, designating it as a Class I recall. Read More
Six device manufacturing facilities landed Form 483s from the FDA after inspections turned up numerous problems with their CAPA, complaint, training and other procedures. Read More
Medical device quality managers that don’t want to wind up a statistic in a future FDA report on quality deviations should dig deeply into the agency’s recently released report on inspections, Form 483s and warning letters, says Michael Gaba, a partner in the law firm Polsinelli. Read More
Brazil’s National Surveillance Agency has added Ireland’s standards authority to its list of accredited organizations to perform quality management system audits under the Medical Device Single Audit Program. Read More
The FDA finalized its list of 1,003 class II medical devices low-risk enough to be exempt from 510(k) requirements, but stressed that all devices, exempt or otherwise, are subject to current device GMPs, packaging and labeling rules, and regulations on intended use. Read More
The FDA’s new pilot program for pre-certifying software for digital medical devices is up and running and companies can now apply to take part in the program. The goal of the new approach is to determine whether a company meets the necessary quality standard. Read More
Whitehall Manufacturing received a warning letter for multiple violations concerning its whirlpool immersion hydrotherapy and dry heat therapy devices. Read More