Sue Darcy, MedTech Insight: January 19, 2021
A last-minute US Department of Health and Human Services (HHS) notice set to waive regulatory review of more than 80 different types of medical devices granted emergency use authorization (EUA) by the Food and Drug Administration to address the pandemic has drawn the concern of a leading medtech product safety advocate.
The 14 January notice exempted from regulation seven types of gloves, but after a comment period and review period of 120 days, the regulators could expand that waiver to another 84 devices, including products critical to addressing the COVID-19 pandemic. (Also see “FDA Suspends Premarket Notification Requirement For 7 Devices; 84 More Under Consideration” – Medtech Insight, 14 Jan, 2021.)
Diana Zuckerman, president of the National Center for Health Research, told Medtech Insight the notice is “mind-boggling” because it might allow any company to sell devices and diagnostics used to fight the coronavirus without first submitting information to the FDA about the products’ effectiveness and safety.
The notice “will certainly please some device manufacturers, but it will put the public health at risk.” – Diana Zuckerman
The notice “will certainly please some device manufacturers, but it will put the public health at risk,” Zuckerman said. She added that she hoped the incoming Biden administration would reverse or stop the notice from taking effect, noting that the HHS and the FDA didn’t give sufficient time for comments from the public.
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In addition to alerting the public health research community about the new HHS/FDA “regulatory flexibility” notice, Zuckerman said her group has been commenting to the FDA on the deregulation of many coronavirus products, testifying before the agency about how to protect patients during the public health emergency, and talking to the new Biden administration and congressional staff about what she called the FDA’s deregulatory activities.
Zuckerman has worked with Congress and FDA for decades, fighting for tougher standards for medtech products that have led to patient harm, including Bayer’s Essure sterilization device, metal-on-metal hips, and pelvic mesh products. (Also see “Public Interest Groups Will Leverage ‘Bleeding Edge’ Lessons To Push For Device Safety Changes” – Medtech Insight, 26 Sep, 2018.)
She raised specific concerns about lowered standards at FDA last year for many molecular tests for COVID-19 that were initially allowed onto the market in spring 2020 for 15 days, minus a review for safety. “So FDA in a sense had already been deregulating diagnostics that potentially weren’t accurate, or may not even have worked – and some of these tests are supposed to save lives,” Zuckerman said.
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Asked about reports of burns from the coils, Zuckerman commented: “Yes, and people who know anything about those MAUDE reports understand they are just the tip of the iceberg – that actually, not all adverse events connected with devices are reported.
“And having read this [notice], the way I look at it is, even if we have MRI coils that have already been reviewed by FDA under 510(k) for safety and efficacy, and the agency said they were safe, what about any new products in that category? This [notice] is saying they would be exempt from any kind of review or regulation at all,” she added.
To read the entire article, see https://medtech.pharmaintelligence.informa.com/MT143355/Patient-Safety-Advocate-Raises-Alarm-Over-HHSFDA-Push-That-Could-Exempt-80-Devices-From-Regulation