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The FDA may withdraw a humanitarian device exemption if it subsequently approves a PMA or clears a 510(k) for the humanitarian-use device or a comparable device with the same indication, a draft Q&A guidance on HDEs explains. Read More
The European Commission’s Scientific Committee on Emerging Newly Identified Health Risks is recommending a step-by-step approach to the introduction of new or technically modified metal-on-metal joint implants, citing continued concerns about the higher risks and poorer durability vis-à-vis alternative materials such as polyethylene. Read More
New FDA draft guidance on blood glucose test systems, released in January, shouldn’t lengthen approval times, a CDRH official assured devicemakers Wednesday during a webinar hosted by the American Association for Clinical Chemistry. Read More
The HHS Office of Inspector General plans to step up efforts to prevent fraud and overspending for diabetes test strips, releasing a host of findings about false claims, questionable billing and pricing. Read More
Citing the growing complexity of medical devices, the U.S. Food and Drug Administration says it will create a devices-only enforcement unit with subspecialists, where necessary, “to carry out effective oversight” of manufacturers. Read More
Devicemakers preparing for an FDA inspection should take steps to avoid some of the most common mistakes, such as lapses in complaint-handling procedures, David Lim, president and CEO of www.RegulatoryDoctor.com, said on a recent FDAnews webinar. Read More
Just as Hospira’s Rocky Mount, N.C., production plant was starting to reel itself back from a devastating 2010 FDA inspection, the facility has been handed a fresh warning letter complaining that its corrective and preventive action procedures for devices fall short of expectations. Read More
The EU Parliament Wednesday advanced major data privacy legislation, but made revisions to the proposal that removed two provisions that industry had said would cripple clinical research efforts. Read More