How software is changing the legal landscape for medical device manufacturers.
FDA has not approved the device for the procedure, called transvascular autonomic modulation.
If you ignore the Federal FD&C Act, you’re tempting fate.
Money should never be a higher priority than safety and efficacy.
The agency says there’s not enough evidence to demonstrate that there’s reasonable assurance of safety and effectiveness.
A Q&A on how device companies can respond to supply chain risks and regulations.
The latest cybersecurity threat reveals how an insulin pump is vulnerable to hackers.
FDA issues safety communication alert for Hospira’s Symbiq Infusion System.
From ensuring patient safety to protecting a company’s reputation, the product recall process starts with putting together the right team of qualified individuals.
The evaluation and management of risk throughout the product life cycle is the single most important concept in the regulation of medical devices. Yet it is difficult to define precisely what “risk” means or how to assess it in an industry where some 115,000 devices are produced by thousands of manufacturers, employing a dizzying array of technologies destined for use in varying health settings for every imaginable indication. So who determines the risk, and where do problems typically arise?