MoFo Life Sciences

June 28, 2024 - Healthcare, United States, Pharma, Medical Devices + Diagnostics
USPTO Seeks Input on Experimental Use Exception to Patent Infringement and Possible Legislative Action
By: Jeffrey W. Schmidt Ph.D. and Karen G Potter Ph.D.
On June 28, 2024, the United States Patent and Trademark Office (USPTO) issued a Notice requesting public comments on the current state of the common law experimental use exception to patent infringement and whether Congress should consider codifying the experimental use exception through legislative
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August 29, 2023 - Intellectual Property, Medical Devices + Diagnostics, United States
A Glimmer of Hope for Simplified Patenting of Medical Diagnostics in the United States
By: Michelle Celine Bradley Ph.D. and John D Chapman Ph.D.
Should the recent bill entitled the Patent Eligibility Restoration Act of 2023 (PERA) become law, it would override the existing jurisprudence and redefine which inventions are eligible for patenting under 35 U.S.C. § 101. By way of the Patent Act of 1952, the United
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June 15, 2023 - AI + Robotics, Digital Health, FDA, Intellectual Property, Medical Devices + Diagnostics, Privacy + Data Security, Regulatory
The Legal and Regulatory Landscape Evolving with AI in Life Sciences
By: Brigid DeCoursey Bondoc and Anna Yuan
Morrison Foerster sponsored and spoke at the Association of Corporate Counsel’s 2023 Life Sciences Conference on May 11, 2023, on the topic of “Artificial Intelligence in Life Sciences: The Evolving Legal and Regulatory Landscape.” Eric Elting of TransPerfect Legal Solutions reported on the discussion.
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April 26, 2023 - AI + Robotics, FDA, Medical Devices + Diagnostics, Regulatory, United States
FDA Publishes Draft Guidance for Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions
By: Brigid DeCoursey Bondoc and Brandy A. Guarda
On April 3, 2023, FDA released the draft guidance titled “ Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions ” (hereinafter “draft guidance”) proposing an approach to support iterative improvement through modifications to a machine
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March 30, 2023 - COVID-19, FDA, Healthcare, Regulatory, Digital Health, Medical Devices + Diagnostics, United States
FDA Issues Final Transition Guidances for COVID-19 Devices
By: Brigid DeCoursey Bondoc
This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or termination of the COVID-19 Emergency Use Authorization (EUA) declarations: 1)
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March 21, 2023 - European Union, FDA, Medical Devices + Diagnostics, Healthcare, Regulatory
Eu Mdr and Ivdr Implementation: New Transitional Regime Enters Into Force
By: Robert Grohmann
On March 20, 2023, the new transitional regime for medical devices in the EU and the EEA became effective when Regulation (EU) 2023/607 (the “ Regulation ”) was published in the Official Journal of the European Union. The Regulation provides for highly anticipated extensions
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February 16, 2023 - COVID-19, United States, FDA, Medical Devices + Diagnostics, Healthcare, Pharma
Ending the COVID-19 Public Health Emergency – What Happens Next
The Biden administration announced on January 30, 2023, that it plans to terminate the COVID-19 public health emergency declaration (the “PHE declaration”) on May 11, 2023. COVID-19 EUA medical products and policies As FDA has clarified in its draft transition guidance for medical devices
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February 08, 2023 - FDA, Pharma, Medical Devices + Diagnostics, Rare Disease, United States
FDORA Passage Brings Significant Changes to FDA’s Drug, Device, and Cosmetic Authorities
By: Brigid DeCoursey Bondoc
The Consolidated Appropriations Act for 2023 was signed into law on December 29, 2022 and includes the Food and Drug Omnibus Reform Act (FDORA). FDORA authorizes a variety of new and important amendments to the Food, Drug, and Cosmetic Act (FDCA) governing drugs, medical
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January 30, 2023 - FDA, Regulatory, United States, Healthcare, Medical Devices + Diagnostics, Pharma
FTC Issues Updated Health Products Claims Guidance
By: Julie Y. Park, Brigid DeCoursey Bondoc and Matt Robinson
On December 20, 2022, the Federal Trade Commission (FTC) issued its Health Products Compliance Guidance (“Health Products Guidance”). This is the first update in nearly 25 years to FTC’s guidance regarding advertising claims for dietary supplements, foods, over-the-counter drugs, and other health-related products. The
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January 24, 2023 - FDA, Regulatory, United States, COVID-19, Medical Devices + Diagnostics
FDA Updates COVID-19 Testing Guidances
By: Brigid DeCoursey Bondoc
Brandy Guarda, Regulatory Analyst in Washington, D.C., contributed to the drafting of this post. UPDATE : The Executive Office of the President announced on January 30, 2023, that the current administration plans to terminate the PHE declaration on May 11, 2023. This announcement does
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Topic Archives: Medical Devices + Diagnostics

USPTO Seeks Input on Experimental Use Exception to Patent Infringement and Possible Legislative Action

By: Jeffrey W. Schmidt Ph.D. and Karen G Potter Ph.D.

A Glimmer of Hope for Simplified Patenting of Medical Diagnostics in the United States

By: Michelle Celine Bradley Ph.D. and John D Chapman Ph.D.

The Legal and Regulatory Landscape Evolving with AI in Life Sciences

By: Brigid DeCoursey Bondoc and Anna Yuan

FDA Publishes Draft Guidance for Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions

By: Brigid DeCoursey Bondoc and Brandy A. Guarda

FDA Issues Final Transition Guidances for COVID-19 Devices

By: Brigid DeCoursey Bondoc

Eu Mdr and Ivdr Implementation: New Transitional Regime Enters Into Force

By: Robert Grohmann

Ending the COVID-19 Public Health Emergency – What Happens Next

FDORA Passage Brings Significant Changes to FDA’s Drug, Device, and Cosmetic Authorities

By: Brigid DeCoursey Bondoc

FTC Issues Updated Health Products Claims Guidance

By: Julie Y. Park, Brigid DeCoursey Bondoc and Matt Robinson

FDA Updates COVID-19 Testing Guidances

By: Brigid DeCoursey Bondoc