The Biden administration has nixed what it described as a “flawed” Trump-era decision to exempt certain medical devices — including infusion pump controllers and fetal monitors — from regulatory review. HHS published the original notice in the Federal Register on Jan. 15, shortly before President Joe Biden was set to take office, without speaking with […]
Dept. of Health & Human Services (HHS)
Companies, docs alarmed by proposed 510(k) rollback
Medical associations and device companies have largely come out against a Trump administration proposal to permanently exempt certain medical devices and software from the FDA 510(k) clearance process. HHS used Trump’s waning days in office to propose permanently exempting 83 Class II devices and one unclassified device from the clearance review process. The list includes home ventilators, […]
Xavier Becerra confirmed as HHS secretary
The U.S. Senate narrowly voted to confirm Xavier Becerra as the U.S. Dept. of Health & Human Services (HHS) secretary today. Becerra received the nomination for the position from President Joe Biden in December 2020. Today, the Senate voted 50-49 in favor of Becerra, who will have to resign his seat as California’s attorney general. […]
Biden to put $12B toward COVID testing
The Biden administration today pledged $10 billion for school COVID-19 screenings and $2.25 billion for screenings and diagnostic testing among underserved populations. The money is part of the $1.9 trillion American Rescue Plan Act that Biden signed into law last week. The Department of Health and Human Services will divvy up the $10 billion among […]
Feds to spend $1.6B to expand COVID testing, domestic manufacturing
The Biden administration announced plans today to expand COVID-19 testing across the country, boost domestic manufacturing of tests and testing supplies and increase virus genome sequencing to detect virus variants. The departments of Health and Human Services and Defense will jointly invest $650 million to expand testing for K-8 schools and underserved congregate settings, such […]
Retractable Technologies lands $54.2M federal contract for syringes
Retractable Technologies (NYSE:RVP) announced that it received a government contract worth more than $54.2 million for its syringes. Little Elm, Texas-based Retractable Technologies’ contract and purchase order was made by the U.S. Health & Human Services Dept. (HHS) with a base price of $54,217,800 for a five-month period between Feb. 15, 2021, and July 14, 2021. […]
Feds order 200M more vaccine doses from Pfizer, Moderna
U.S. government agencies announced that they purchased a total of 200 million additional doses of COVID-19 vaccines from Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA). The orders of 100 million doses from each of the only two FDA-authorized vaccines in the U.S. were made by the U.S. Health & Human Services Dept. (HHS) and the Defense Dept. (DoD). The […]
Biden administration orders home COVID-19 tests
The U.S. Defense Dept. announced today that it awarded Ellume $231.8 to onshore production capacity of its Ellume COVID-19 home test. In coordination with the U.S. Dept. of Health and Human Services (HHS), the DoD contract is an industrial base expansion to allow Ellume to increase the production capacity of its home test by 640,000 […]
HHS could make permanent pandemic-related exemptions for some devices
HHS has used the Trump administration’s waning days to propose permanently exempting certain medical devices — including infusion pump controllers and fetal monitors — from the FDA 510(k) clearance process. In a notice published Jan. 15, 2021, in the Federal Register, the agency also listed seven types of patient examination gloves that it has decided to immediately […]
MedTech 100 roundup: Industry skyrockets as hot streak continues
The medtech industry’s seemingly unstoppable rise over the past several weeks shows no signs of slowing down. For the fourth time in five weeks, and for the third consecutive week, the MassDevice MedTech 100 Index — which includes stocks of the world’s largest medical device companies — hit an all-time high. Previous highs have largely been […]
HHS seals plan to sunset regulations 10 years or older
The U.S. Department of Health and Human Services (HHS) today issued a final rule giving it five years to review and potentially sunset regulations that have been in place for at least 10 years. With some exceptions, the agency will look into whether regulations cause financial harm to a substantial number of small entities. It will also […]
