MoFo Life Sciences

May 13, 2021 - United States, FDA, COVID-19, Healthcare
New Face Mask Performance Standard Has Consumers Covered
ASTM International recently approved a new performance standard that will tell consumers just how much protection their cloth face masks offer. Some face coverings like N-95 respirators and surgical masks must meet certain filtration requirements enforced by government agencies like the U.S. Occupational Safety
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May 11, 2021 - United States, FDA, COVID-19, Healthcare, Pharma
COVID-19 Vaccines: And Then There Were Three (Again)
On December 11, 2020, a SARS-CoV-2 (COVID-19) vaccine developed by Pfizer and BioNTech became the first to receive Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Since then, two others (produced by Moderna and Johnson & Johnson) have also been
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May 06, 2021 - AI + Robotics, FDA
CTA Publishes New Standard for Healthcare AI
In February, the Consumer Technology Association (CTA) announced a voluntary standard for healthcare products that use Artificial Intelligence (AI). This standard follows the Food and Drug Administration’s (FDA) recently published action plan for regulatory oversight of AI and machine learning-based medical software. FDA ultimately
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May 04, 2021 - FDA, Litigation
Ninth Circuit Weighs in on Fraud-on-the-FDA Theory, Marketing Devices for Off-Label Use, and Kickbacks
The Ninth Circuit recently weighed in on the appeal of a False Claims Act lawsuit from a relator against Medtronic. In this case, the relator alleges that Medtronic, Inc.: (1) Engaged in “fraud-on-the-FDA” when obtaining clearance for several devices used in spinal fusion surgeries;
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April 08, 2021 - United States, FDA, Medical Devices + Diagnostics, United Kingdom, European Union, Regulatory
Global HealthTech CEO Connect: Software as a Medical Device in the U.S. and EU Recap
By: Wolfgang Schönig
On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device (SaMD) in both the United States and Europe and specific
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April 06, 2021 - United States, FDA, Medical Devices + Diagnostics, Regulatory
FDA Clinical Decision Support Software vs. EU’s Medical Device Regulation
In follow-up to our colleagues recent post about the newly implemented Medical Device Regulation (“MDR”) in the European Union, this post will discuss some of the similarities between FDA’s Clinical Decision Support (“CDS”) Software Draft Guidance (together the “CDS Draft Guidance”) and the MDR.
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March 31, 2021 - United States, FDA, COVID-19, Healthcare, Pharma
Vaccine Production and State Intervention in the U.S.
By: Brigid DeCoursey Bondoc
During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector.[1] State-owned enterprises have long been common in Asia, but the pandemic has increased their prominence in Europe. In Italy and Norway, for instance, governments are taking equity stakes
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March 03, 2021 - AI + Robotics, United States, FDA, Regulatory
FDA’S PLAN FOR AI/ML-BASED SOFTWARE AS MEDICAL DEVICES: PROGRESS AND CONCERNS
By: Jean Nguyen
U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory oversight. The FDA recently published an AI/ML SaMD action plan, developed in direct response to
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March 01, 2021 - FDA, COVID-19, Rare Disease, Biotech, Healthcare, Pharma, Regulatory
Rare Disease: Sustained Progress in Development Regardless of the Pandemic
By: Catherine M. Polizzi
Sunday, February 28, 2021, was Rare Disease Day. With so much focus on COVID-19 throughout 2020, it’s important to recognize the continued work done in rare disease drug development by sponsors and FDA throughout 2020. In addition, a number of policies implemented in response
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December 30, 2020 - FDA, COVID-19, Product Liability + Class Action
FDA’s Covid-19 Product Regulation Enforcement Roadmap
By: Erin M. Bosman and Julie Y. Park
Navigating FDA’s regulatory enforcement strategies is paramount to successfully marketing health and medical products for COVID‑19—especially since the pandemic has dominated FDA’s enforcement activity this year. Understanding the patterns and principles behind FDA’s efforts can provide the insight product manufacturers need to avoid FDA
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Topic Archives: FDA

New Face Mask Performance Standard Has Consumers Covered

COVID-19 Vaccines: And Then There Were Three (Again)

CTA Publishes New Standard for Healthcare AI

Ninth Circuit Weighs in on Fraud-on-the-FDA Theory, Marketing Devices for Off-Label Use, and Kickbacks

Global HealthTech CEO Connect: Software as a Medical Device in the U.S. and EU Recap

By: Wolfgang Schönig

FDA Clinical Decision Support Software vs. EU’s Medical Device Regulation

Vaccine Production and State Intervention in the U.S.

By: Brigid DeCoursey Bondoc

FDA’S PLAN FOR AI/ML-BASED SOFTWARE AS MEDICAL DEVICES: PROGRESS AND CONCERNS

By: Jean Nguyen

Rare Disease: Sustained Progress in Development Regardless of the Pandemic

By: Catherine M. Polizzi

FDA’s Covid-19 Product Regulation Enforcement Roadmap

By: Erin M. Bosman and Julie Y. Park