Quality Management System Regulation (QMSR) – Harmonizing the Quality System Regulation (QSR) with ISO 13485:2016
- Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post. The U.S. Food and Drug Administration (FDA) issued the much-anticipated proposed rule “Medical Devices: Quality System Regulation Amendments,” which will harmonize the current Quality System Regulation... ›
MoForum Recap: Transformation Across the Industry
Our recent Life Sciences MoForum included in-depth discussions with industry insiders on the convergence of the life sciences with technology and healthcare and the trends that are driving the industry across the digital health, diagnostic, and drug markets. Digital Transformation in the Life Sciences... ›Latest Genetic Data Privacy Law Goes into Effect
By: Melissa M. Crespo
California is ringing in the New Year with new privacy and security protections for genetic data. On January 1, 2022, California’s new Genetic Information Privacy Act (GIPA) became the latest state genetic data privacy law to go into effect, adding to a growing number... ›3 Key Takeaways from FDLI’s FDA Center Compliance Directors: Presentations and Q&A Session
By: Rachel Park
FDLI hosted a virtual Enforcement, Litigation, and Compliance Conference December 9–10, 2021. The session titled Compliance Central with FDA Center Compliance Directors: Presentations and Q&A addressed FDA’s top compliance issues, enforcement priorities, and goals for 2022. The session included presentations from Ann Oxenham (CFSAN),... ›De Novo Classification Final Rule to Take Effect Next Year
By: Brigid DeCoursey Bondoc
On Tuesday, December 14, 2021, the U.S. Food and Drug Administration (FDA) hosted a webinar discussing the final rule , Medical Device De Novo Classification Process, and associated guidance document updates. The final rule, which will take effect on January 3, 2022, codifies the... ›AI TRENDS FOR 2022 - FDA REGULATORY
FDA is actively monitoring the use of AI and machine learning (ML) software in medical devices and clinical developments, and has taken a number of first steps in building out a regulatory framework. In 2021, FDA published the AI and Machine Learning Software as... ›Morrison & Foerster Partners Speak at FDLI’s Digital Health Technology and Regulation Conference
By: Stacy Cline Amin and Rachel Park
The Food and Drug Law Institute (FDLI) hosted the virtual conference Digital Health Technology and Regulation During COVID-19 and Beyond , November 9-10, 2021. Morrison & Foerster’s Stacy Cline Amin and Bethany Hills led panel discussions during the two-day conference. Stacy Cline Amin, who... ›FDA and International Counterparts Release Best Practices for Machine Learning in Medical Device Development
By: Rachel Park
This week the U.S. Food and Drug Administration (FDA), along with Health Canada and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), identified 10 guiding principles to inform the development of Good Machine Learning Practice (GMLP) and promote safe and effective medical... ›Five Key Takeaways from FDA’s Transparency of AI/ML-Enabled Medical Devices Virtual Workshop
By: Rachel Park and Stacy Cline Amin
On October 14, 2021, the Food and Drug Administration (FDA) held a virtual public workshop on transparency surrounding Artificial Intelligence/Machine Learning (AI/ML) enabled medical devices. The workshop focused on the role of transparency in enhancing the safe and effective use of AI/ML technology in... ›Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 6 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
In Part 6 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will govern medical devices software (“MDSW”) in the EU, we turn to the transition periods certain MDSW can benefit from before... ›