The FDA has removed the “acting” from Dr. Michelle Tarver’s title as head of the Center for Devices and Radiological Health (CDRH). The FDA announcement comes about three months after Dr. Jeff Shuren stepped down as head of CDRH after 15 years as medtech’s top regulator — with plans to retire by the end of […]
Center for Devices and Radiological Health (CDRH)
CDRH’s Shuren says they’re ‘starting to turn the corner’ from COVID-19
Medical device industry insiders will have to wait until the new year to get a better idea of the post-pandemic priorities at the FDA’s CDRH. That was one of the big takeaways from Dr. Jeff Shuren’s remarks at the virtual CDRH Town Hall held yesterday at AdvaMed’s The MedTech Conference, which takes place this week as a […]
FDA issues mea culpa for early COVID-19 serology test nods
Early in the pandemic, when the numbers of asymptomatic COVID-19 cases were mounting, officials at the FDA decided to authorize the use of serology tests that laboratories had validated but that the agency hadn’t actually reviewed. Now two FDA officials are admitting that this was a mistake, but one the agency has learned from. In […]
FDA warns Battelle on reporting mask decontamination problems
The FDA is warning Battelle Memorial Institute that it must improve its adverse event reporting procedure for decontaminating N95 masks for reuse by frontline healthcare workers treating COVID-19 patients. The agency granted an emergency use authorization (EUA) in March for the Battelle Critical Care Decontamination System (CCDS), which uses vaporized hydrogen peroxide to reprocess used N95 […]
CDRH director Shuren says flexibility remains key as COVID-19 strains regulatory system
Dr. Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health (CDRH), believes the level of flexibility shown by the FDA during the COVID-19 pandemic may be needed in a post-pandemic world. Speaking in a town hall event at The Virtual Medtech Conference hosted by AdvaMed, Shuren outlined the work the FDA has put […]
FDA adds reference panel to study COVID-19 diagnostics
The FDA has released a new reference panel to evaluate diagnostic tests for COVID-19. Reference panels are an additional step to ensure the quality of the tests, validation of new assays, test calibration and monitoring of assay performance, according to the agency. Nucleic acid tests identify infection by confirming the presence of a virus’ genetic […]
CDRH gives medtech manufacturers employee coronavirus safety tips
As certain medtech companies continue ramping up production of devices and components to fight the coronavirus, the FDA’s Center for Devices and Radiological Health (CDRH) on Sunday announced several tips to help protect medtech manufacturing employees from contracting COVID-19. In addition to frequent and thorough hand-washing, maintaining social distancing and avoiding face-touching, the agency urged […]
FDA panel wants info on metal implant reactions
This article has been updated with a link to the FDA webcasts of the proceedings. An FDA panel will meet this week to discuss immunological responses to medical device implants made of metal, including artificial hips and the Essure permanent birth control device. The Immunology Devices Panel of the agency’s Center for Devices and Radiological […]
FDA grants $3m to MDIC for quality improvment, cybersecurity programs
The Medical Device Innovation Consortium said this week that it won nearly $3 million in funding from the FDA for the expansion of its case for quality and medical device cybersecurity programs. MDIC plans to put the $2.8 million award toward medical device manufacturing sites with quality system issues or ones that have been out […]
CDRH proposes women’s health plan
The FDA has released a new proposed plan to improve medical device safety for women. The agency’s Center for Devices and Radiological Health (CDRH) said today that the proposed strategic plan will address sex- and gender-specific issues in medtech design, development, clinical trial design and other medical device-related matters. The strategic plan is part of […]
CDRH sets science priorities
The FDA’s Center for Devices and Radiological Health (CDRH) released its latest top 10 regulatory science priorities yesterday. They are: Use Big Data to aid in regulatory decision-making. Modernize biocompatibility and biological risk evaluation of device materials. Use real-world evidence and evidence synthesis across multiple domains in regulatory decision-making. Advance tests and methods for predicting […]
