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Congress is aiming to hold the device industry’s feet to the fire on cybersecurity by proposing new requirements in the fifth reauthorization of the Medical Device User Fee Act (MDUFA V). Read More
Companies that market in vitro diagnostic devices (IVDs) in the EU may continue to use existing certificates after the EU’s new In Vitro Diagnostics Regulation (IVDR) goes into effect on May 26 as long as they do not make “significant” changes to the products’ design or intended purposes. Read More
The FDA on Friday issued a draft guidance on its Voluntary Improvement Program (VIP), which uses third-party quality appraisals to help manufacturers improve their production and quality practices, signaling VIP’s transition from a pilot to a permanent program. Read More
The FDA issued a final guidance explaining its current policy on when agency staff may refuse to consider device companies’ applications for 510(k) clearance of a new product. Read More
A consumer of lidocaine patches sold by Target has filed a class-action lawsuit against the retailer, claiming that the devices don’t stick to the skin and aren’t strong enough. Read More
Developers of devices that are intended to improve glycemic control in patients with type 2 diabetes should conduct an early-stage feasibility and safety study to support additional trials that further hone in on feasibility, the FDA said in a final guidance. Read More
The FDA released a revised guidance clarifying when device sponsors that make certain low-risk product changes may not have to submit supplements for already approved premarket approvals (PMAs) or humanitarian device exemptions (HDEs) during the COVID-19 public health emergency. Read More
Belgium-based Ion Beam Applications (IBA) has acquired Modus Medical Devices, a Canadian manufacturer of “phantoms” used for quality assurance in radiation therapy. Read More
The FDA has issued a warning about counterfeit COVID-19 test kits that are being marketed in the U.S. — including fake Flowflex COVID-19 test kits and iHealth COVID-19 antigen rapid test kits. Read More
The FDA has clarified that it does not plan to regulate most software apps used in public health — such as the case-counting software programs that have been in use throughout the pandemic — as medical devices. Read More