Companion Diagnostics Regulations are Evolving in Asia Personalized medicine is experiencing a global surge in popularity, with Companion Diagnostics (CDx) products playing a pivotal role in facilitating this expansion. While CDx products are being used frequently in the West for personalized medicine, in the future, providers in Asia will also use more CDx products …
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Preparing for EU MDR Post Market Reporting EU MDR continues to pose challenges as companies prepare to recertify devices and bring new technologies to the European market. One of the big changes in the regulatory framework of EU MDR versus the current medical device directive (MDD) is the focus on post market surveillance (PMS) …
Medcrypt Appoints Former FDA Officer to Vice President of Services Naomi Schwartz, former premarket reviewer and consumer safety officer for the FDA, has been promoted to serve as Vice President of Services at Medcrypt, a cybersecurity solution provider for medical device manufacturers. In this new role, Schwartz will provide regulatory guidance to medtech companies …
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FDA Withdraws from Global Harmonization Working Party On November 27, the FDA announced its withdrawal as a member of the Global Harmonization Working Party (GHWP), which the agency joined in December 2021. The FDA stated that it will continue its outreach to global partners and its efforts to ensure alignment of medical device international …
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Ask the Expert: Benefits and Challenges of the eStar Submission Process As of October 1, 2023, all U.S. FDA 510(k) submissions, unless exempted, must be submitted as electronic submissions using the eSTAR platform. In this column, Dr. Dhriti Roy, vice president of Regulatory Affairs Transformation at Essenvia and faculty at Oxford University’s MedTech innovation …
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Bringing Digital Health Products to the Global Market In recent years, the growth and acceptance of digital health products has skyrocketed. Global regulation and market access for these devices, however, is as variable as the potential indications they address. We spoke with Megan Coder, Vice President for Product and Policy at the Digital Medicine …
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Preparing for the PATCH Act and RTA The Protecting and Transforming Cyber Health Care Act of 2022 (PATCH Act) comes into force on October 1, 2023. The Act strengthens cybersecurity requirements for medical device pre-market submissions and post-market surveillance. Companies must develop a product monitoring plan, cyber-anomaly response plan, coordinated messaging of cyber vulnerabilities, …
FDA Issues Final Guidance on Cybersecurity in Medical Devices The FDA has issued the final guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The guidance replaces Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued on October 2, 2014. This document provides recommendations on medical device cybersecurity …
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FDA Updates Breakthrough Devices Program Guidance The FDA has issued an update to the final guidance: Breakthrough Devices Program. The updates are intended to clarify how the Breakthrough Devices Program applies to certain innovative medical devices that may address health inequities, as well as devices that may offer a non-addictive option to treat pain or …
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FDA Releases Two Discussion Papers on Artificial Intelligence and Machine Learning in Drug Development and Manufacturing On May 10, the FDA released two discussion papers on the use of artificial intelligence and machine learning (AI/ML) in drug development and manufacturing. In a statement introducing the papers, Patrizia Cavazzoni, M.D., Director of the FDA Center …
