Medical Devices

FDA has identified a recent recall of Medtronic insulin pumps as a class I recall, the most serious category of device recalls reserved for products that can result in serious injury or death.

The medical device lobby is actively working with the Chinese and U.S. governments and stakeholders to ensure providers and patients have access to medical technologies that can help diagnose and prevent the spread of novel coronavirus, the group told Inside Health Policy on Thursday (Jan. 30), amid reports that China is experiencing shortages of masks, gowns and gloves.

The over-the-counter drug lobby will broaden its focus to include consumer medical devices, and it plans to work with FDA to establish a definition and standards separate from those used to regulate more traditional medical devices, the Consumer Healthcare Products Association told Inside Health Policy.

The House Energy & Commerce health panel will review legislative proposals that aim to end gaming of the Orphan Drug Act, improve generic drug labeling and foster continuous manufacturing at a legislative hearing Wednesday (Jan. 29).

The House Energy & Commerce oversight subcommittee’s top Republican is pushing legislation that would give FDA authority to seize and destroy counterfeit medical devices, combination products and vaccines coming across U.S. borders.

FDA will hold a public meeting March 27 to gather input on efforts to reform its data strategy, which the agency laid out in its Technology Modernization Action Plan (T-MAP) in September.

FDA on Friday (Dec. 20) finalized a guidance that details how manufacturers can develop dried plasma products and gain approval of devices used to manufacture dried plasma for application beyond the battlefield.

Health stakeholders are praising Senate and House appropriators for permanently repealing the so-called “Cadillac” health insurance and medical device taxes in the end-of-year spending package released Monday (Dec. 16), following years of lobbying to get rid of the industry taxes Congress had passed to offset the coverage expansion in the Affordable Care Act.

Sen. Ted Cruz (R-TX) and other conservative lawmakers intend to pursue an expansion of FDA’s Parallel Track program if Stephen Hahn is appointed as FDA commissioner, even though FDA already has similar programs, such as Expanded Access, already in place, as well as a new pilot program, Project Facilitate.