Search the Releasable 510(k) Database CDRH maintains searchable databases on its website containing 510(k) and PMA information A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket […]
FDA, Gates Foundation, UnitedHealth Group, Quantigen, and U.S. Cotton Collaborate to Address Testing Supply Needs
FDA, Gates Foundation, UnitedHealth Group, Quantigen, and U.S. Cotton Collaborate to Address Testing Supply Needs FDA, Gates Foundation, UnitedHealth Group, Quantigen, and U.S. Cotton Collaborate to Address Testing Supply Needs
FDA Encourages Recovered Patients to Donate Plasma for Development of Blood-Related Therapies FDA Encourages Recovered Patients to Donate Plasma for Development of Blood-Related Therapies
COVID-19: EU recommendations for community measures COVID-19: EU recommendations for community measures
COVID-19: EU recommendations for testing strategies Timely and accurate laboratory testing is an essential part of the management of COVID-19. Robust testing strategies have shown to be an important tool in slowing down the epidemic, supporting decisions on infection control strategies at the health care facilities and improving the knowledge of virological aspects of COVID-19.
The Best CPAP Machines Continuous positive air pressure devices or CPAP machines are often used to treat sleep apnea, a medical condition that causes a transient breath loss during the night. CPAP machines are electronic equipment that pulls air through an internal fan, moisturizes the air, pressures it, and then transmits it through the connected […]
Coronavirus (COVID-19) Update: FDA Issues Second Emergency Use Authorization to Decontaminate N95 Respirators
Coronavirus (COVID-19) Update: FDA Issues Second Emergency Use Authorization to Decontaminate N95 Respirators For Immediate Release: April 10, 2020 The U.S. Food and Drug Administration issued the second emergency use authorization (EUA) to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings. This EUA will support decontamination of approximately 750,000 N95 […]
COVID-19: European Commission recommendations on health systems resilience The COVID-19 pandemic puts enormous strain on healthcare systems. Most EU Member States have put in place measures to relieve pressure, therefore, helping in the diagnosis and treatment of the disease.
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FDA: Initiation of Voluntary Recalls From the Federal Register, Wednesday, April 24, 2019: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.’’ The draft guidance, if finalized, would establish guidance for industry and […]