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In a new guidance on ethical issues, the Advanced Medical Technology Association (AdvaMed) advises against letting a device company’s sales department select as trainers if the company aims to implement bona fide training and education programs for healthcare professionals (HCPs). Read More
Manufacturers of legacy devices that were not designed with cybersecurity in mind must tell customers during the procurement process when they will stop providing cybersecurity support, the International Medical Device Regulators Forum (IMDRF) advises in a just-published draft document. Read More
The FDA was slow to begin phasing out its policy that allowed the emergency authorization of hundreds of COVID-19 tests before their efficacy was proven. Read More
Under FDA medical device regulations, all products must be fully verified, generally by postproduction test or inspection, to ensure that they meet each of their design specifications. The agency defines a product as anything created by a process, including individual components of a device, materials involved in manufacturing the device — whether or not those materials are a part of the finished device — and even the in-process device itself. Read More
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The FDA on Friday issued a draft guidance on its Voluntary Improvement Program (VIP), which uses third-party quality appraisals to help manufacturers improve their production and quality practices,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