Drugs

Medical Device EUAs Likely to End in 2021: Recall Report

The Sedgwick Brand Protection State of the Nation 2021 report predicts that by mid- to late-2021 FDA will start revoking medical device emergency use authorizations, reverting to unapproved status devices that were not approved by regular means. The report cautions that legal protections currently offered to manufacturers and distributors of such products will most likely no longer exist, meaning that companies will need to demonstrate a good safety and marketing record and no evidence of Covid-19 fraud in any liability or other cases that come up.

The report says there will likely be Warning Letters or recalls involving medical device and drug Covid-19 fraud charges for products that claim to test for Covid-19; treat, fight, or inhibit the virus; prevent or reduce Covid-19 risk, or treat or reverse Covid-19 symptoms.

There were 1,078 medical device recalls in 2020, a 22% increase over 2019. Some 467 million units were affected, the highest number since 2012. Software issues remained the leading recall reason in 18 of the last 19 quarters and for 2020 as a whole.

On the drug side, there were 344 recalls in 2020, a modest 2.4% increase over 2019. However, the 133 million units involved was a 51% increase over 2019. The leading recall cause for the year was current good manufacturing practice deviations, accounting for 47% of recalled units.

The report says the number of NDMA-related recalls increased from 12 in 2019 to 36 in 2020. FDA identified more than 1,200 fraudulent Covid-19 products in 2020 and the report predicts that the clampdown on counterfeiting will remain a priority in 2021.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome