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Month: January 2022

FDA Announces Release of “FDA Guidance: Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions”

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Computational modeling and simulation (CM&S) can sometimes be useful to demonstrate the safety and effectiveness of medical devices or incorporated into devices. On December 23, 2021, the U.S. Food and Drug Administrations (FDA) announced the release of a draft guidance, “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions,” to provide clarification … Continued

Considerations for Medical Device Histology Tissue Preparation

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Histology is a critical step for any preclinical study when bringing a medical device to market and should not be overlooked when considering development timelines. Tissue histology provides U.S. FDA regulators with physical evidence, down to the cellular level, regarding how a device interacts with tissue

New Implementing Regulation Released to Provide Guidance on Electronic Instructions for Use (eIFU) under MDR

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On 14 December 2021, the European Commission published a new Implementing Regulation, (EU) 2021/2226, explaining the rules regarding the application of the Medical Device Regulation (MDR). Specifically, this document highlights the provision of electronic instructions for use (eIFU) for medical devices, which came into force on 4 January 2022.

European Commission Releases Further Harmonised Standards under EU MDR

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The New Year saw the European Commission (EC) publish a second batch of harmonised standards under the EU MDR. Commission Implementing Decision (EU) 2022/6, released on 4 January 2022, amends the earlier Implementing Decision (EU) 2021/1182 published in July 2021. It introduces a further nine harmonised standards that medical device manufacturers should reference to satisfy conformity requirements under the MDR.

FDA Issues COVID-19 Transition Plans for EUA and Enforcement Actions

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Following the declaration by DHS of the COVID-19 Pandemic, the FDA began to issue Emergency Use Authorization (EUA) approvals and enforcement policies for devices used to mitigate the spread of the SAR-CoV-2 virus, including the diagnosis, treatment or prevention of Coronavirus Disease (COVID-19). On, December 23, 2021, the Agency acknowledged the general need for a transition process back to ‘normal operations’ and released two draft guidance documents that introduce their proposed transition plans.