The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA: Curative test for COVID should be conducted per product label; FDA posts MEA final guidance; CMS eyes radiology quality measures; Ra Medical agrees to fines.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MDCG posts guidance agenda for 2021; CPC comments on FDA’s skin biocompatibility draft.
LONDON – The COVID-19 vaccine developed by Astrazeneca plc and Oxford University has been approved by the U.K regulator, with the first doses being shipped on Dec. 30 and a mass vaccination program due to begin on Jan. 4. AZD-1222, now named COVID-19 Vaccine Astrazeneca, is authorized for emergency use and will require two doses for durable effect.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: U.S. FDA provides updates on power morcellation; FDA seeks nominations for advisory committee; CDSCO suspends import notification requirements.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS unveils push toward digital collection of quality measures; NIH awards for ‘outside-the-box’ projects under RADx; ISO posts IP management standard.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: DOJ arraigns test maker for investor fraud.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: EPA posts ethylene oxide rule on OMB agenda; HHS announces sustained support for testing; FTC gives nod to Stryker/Wright deal.
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