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European trade groups and industry experts were cautiously optimistic regarding news that medtech oversight will move from the health directorate to industry, with some saying it will boost innovation and access to new therapies and others worried it could derail progress on regulatory reforms in the EU. Read More
The International Medical Device Regulators Forum’s single-audit pilot program is running on schedule, an FDA official working closely with the program tells IMDRM. Read More
The European Commission will soon launch an internal test of the International Medical Device Regulators Forum’s table of contents for medical devices and IVDs — documents designed to ease marketing authorizations process when companies file in multiple countries. Read More
This past spring, officials at the Saudi Food and Drug Authority destroyed millions of dollars’ worth of expired medical devices that were seized at ports, as part of a government effort to ensure products entering the country are valid and safe. Read More
Notified bodies should conduct unannounced audits of facilities that make Is/Im and in vitro diagnostic self-tests every two years if the product carries a high risk, is often noncompliant with EU regulations or otherwise raises concerns about manufacturing and quality deviations, Team-NB says in its updated industry conduct code. Read More
Clinical trial investigators in India must limit their work to no more than three trials at any given time, according to one of the mandates in 14 finalized regulations issued by the Central Drugs Standard Control Organization.
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Industry is raising concerns about a new Turkish regulation that bans advertisements of certain medical devices and requires device sales centers to be government-certified and employ “qualified” persons. Read More
Companies filing premarket approval applications for companion diagnostics may explain the clinical significance and clinical cut-off of their products using a summary of the clinical results for the corresponding drug product, recent technical guidance from Japan’s Pharmaceuticals and Medical Devices Agency says. Read More
Manufacturers are all but blocked from using split predicates for 510(k) devices, under a newly finalized U.S. Food and Drug Administration guidance on substantial equivalence determinations. Read More
For the first time, manufacturers submitting 510(k)s would have to show U.S. Food and Drug Administration reviewers that the risks and benefits of a candidate device are acceptable and substantially equivalent to those of the predicate device, according to draft guidance issued last week. Read More
Manufacturers of medical devices that contain nanomaterials should use a phased approach to evaluate risk to avoid unnecessary testing, an expert committee of the European Commission recommends. Read More