A wide variety of medical device stakeholders gave the Food and Drug Administration suggestions on how to improve the draft guidance for implementing the Global Unique Device Identification Database (GUDID).
Consultants for Booz Allen Hamilton recommend that the FDA implement more training, metrics and quality management to improve the consistency and transparency of the medtech review process.
This joint pilot of the FDA’s Center for Devices and Radiological Health (CDRH) and Office of Regulatory Affairs (ORA) is part of FDA’s ongoing effort to apply innovative strategies that promote medical device quality. VCIP differs from the FDA’s traditional oversight model by allowing firms to voluntarily self-identify and correct possible regulatory violations instead of undergoing FDA inspection. Types of problems identified by these manufacturers may include quality system violations and other problems, such as failure to satisfy device clearance or approval requirements or adverse event reporting requirements. Firms with violations that raise imminent public health concerns – such as a reasonable probability that use of or exposure to a product will cause serious adverse health consequences or death – may not participate in the program.
The US Food and Drug Administration (FDA) has published a new draft guidance on the studies needed to support an abbreviated new drug application (ANDA), more commonly known as generic drug applications.
GlobalData analysts anticipate that new cholesterol treatment guidelines will be “hard to swallow” for manufacturers of other lipid-lowering drug classes, such as Merck’s & Co.’s Zetia and AbbVie’s Trilipix as the new recommendations all but discredit the usefulness of these products. Despite this, GlobalData analysts say that the updated guidelines for treating hypercholesterolemia and atherosclerotic cardiovascular disease (ASCVD) could give the statin market a substantial boost in the coming years.
US Food and Drug Administration (FDA) officials quietly announced late on a Friday in November that their biologics online submission system had been “compromised” by an unauthorized user—hacked, in common parlance—leading to the access of users’ account information, e-mail addresses and passwords.
The World Health Organization and Health Care Without Harm, an international coalition of 473 entities in 50 countries, are calling for a global phase-out of mercury-containing fever thermometers and blood pressure cuffs by the end of this decade.
Through the Case for Quality, the FDA is working with stakeholders—industry, healthcare providers, patients, payers, and investors – to foster medical device quality. Enhancing the quality of medical devices is in the best interests of all, especially industry and patients. This is achieved by identifying and promoting practices that result in high-quality devices and adapting FDA regulatory approaches to align with those practices. Ultimately, this provides stakeholders with understandable and objective information about medical device quality; facilitates medical device innovation and quality through data and analysis on device performance; and fosters strategies that focus stakeholder interactions on device quality.
The China Food and Drug Administration plans to step up its tracking of medical device adverse events in hospitals, and is asking high-risk and Class III device makers to refer to a 2011 guideline on electronic monitoring to facilitate submission of incident reports.
A recent decision by the EU Court of Justice on borderline products affirms a practice by member states that can pose challenges for devicemakers, says Erik Vollebregt of Axon Lawyers in the Netherlands. The court ruled in case C-109/12 that individual member states may classify the same product differently, whether as a medicinal product requiring clinical data or as a medical device.