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USA: US FDA Voluntary Medical Device Manufacturing and Product Quality Pilot Program – June 2022

USA: US FDA Voluntary Medical Device Manufacturing and Product Quality Pilot Program – June 2022

  • 2022-06-29 03:18:32

The U.S. Food and Drug Administration has released a new draft guidance to further a voluntary program aiming to improve quality-related processes in medical device manufacturing. The concept comes from the Medical Device Innovation Consortium (MDIC), which assesses the capability and performance of key business processes using a maturity appraisal model tailored to the medical device industry. The overall stated goal is to enhance the quality processes and to improve the overall medical device quality, as to ultimately ensure better patient treatment outcomes.

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USA: Low-Risk Novel Products Can Avoid Automatic Class III Designation from US FDA – March, 2022

USA: Low-Risk Novel Products Can Avoid Automatic Class III Designation from US FDA – March, 2022

  • 2022-03-25 11:58:47

The US Food and Drug Administration (FDA) has updated several regulations affecting De Novo classification of novel medical devices. The main purpose is to present an objective and balance for the scientific evidence to be the foundation to grant a De Novo request. Also, the De Novo products will serve as future predicate devices for prospective 510(k) registration applications to improve and extend the existing 510(k) database.

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USA: FDA Transition Plan for Emergency Use Authorizations (EUAs) Medical Devices – February, 2022

USA: FDA Transition Plan for Emergency Use Authorizations (EUAs) Medical Devices – February, 2022

  • 2022-02-18 09:37:25

The US FDA is planning to issue transition plans for medical devices with Emergency Use Authorizations (EUAs). The EUA measure had previously been implemented in order to increase related necessary medical product supply on the US market.
As the Coronavirus Disease 2019 (COVID-19) pandemic gradually slows down, FDA has published a draft guidance to provide its recommendations to manufacturers, and in order to outline a roadmap for EUA devices to be able to transition after the emergency use declarations are no longer in effect in the future.

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USA: FDA Modifies List of Recognized Standards – June, 2021

USA: FDA Modifies List of Recognized Standards – June, 2021

  • 2021-06-25 12:45:15

According to FDA Modernization Act, FDA publishes a series of recognized consensus standards modifications. FDA believes these modifications are closer to modern requirements for medical devices to ensure public benefit improvement. The medical device manufacturers should notice the standards change to avoid the FDA challenge.

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