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The Centers for Medicare & Medicaid Services seeks industry input as it considers new payment rules and an expansion of the competitive bidding program for durable medical equipment and enteral nutrients, supplies and equipment. Read More
The FDA’s decision to make growth in U.S. clinical trials a high priority is leading to new guidances, shortened approval waits on IDEs and a new position dedicated to handling device trial issues. Read More
HHS’ health IT coordinator is calling for all electronic health records to incorporate the unique device identifiers of implantable devices by 2015. Read More
Endo Pharmaceuticals has entered into a five-year corporate integrity agreement with HHS to resolve marketing violations surrounding the Lidoderm patch, a popular painkiller. Read More
Manufacturers of diagnostics designated for research or investigational use only should limit their use to the earliest stages of device development, Alberto Gutierrez, director of CDRH’s Office of In Vitro Diagnostics and Radiological Health, said during a Wednesday webinar sponsored by the American Association for Clinical Chemistry. Read More
The FDA’s draft guidance on 510(k) submissions for nucleic acid-based HLA test kits has raised concerns about manufacturing delays for new test kits and increased costs for devicemakers. Read More
The reorganization of CDRH’s Office of Compliance and creation of a Division of Manufacturing Quality has provided a shot in the arm to the center’s Case for Quality Initiative — fueling two pilot programs designed to increase inspection efficiencies without sacrificing quality, OC Director Steve Silverman says. Read More
Advanced Magnetic Research Institute received an FDA warning letter related to violations in three clinical studies of a magnetic molecular energizer, including failure to get IRB approval. Read More
Devicemakers that make modest improvements to their products will, in most cases, not need to file a new 510(k), the FDA says in a report released to Congress on Tuesday. Read More
House and Senate lawmakers are demanding the FDA strengthen its whistleblower protections after concluding the agency improperly spied on emails of five agency scientists in the CDRH device review division who reported product safety concerns to Congress. Read More
There’s now a strong possibility the European Parliament won’t finalize proposed medical device and IVD regulations before elections this May, a lawyer familiar with the legislation says. Read More