MoFo Life Sciences

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Union, this post will discuss some of the similarities between FDA’s Clinical Decision Support (“CDS”) Software Draft Guidance (together the “CDS Draft Guidance”) and the MDR.
... ›
March 24, 2021 - Medical Devices + Diagnostics, European Union, Regulatory
Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 5 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
The preceding articles of this series laid out how the new EU Medical Device Regulation 2017/745 (“MDR”) leads to a broader coverage of medical devices and an overall deeper level of regulation in areas already regulated before. This episode will put the spotlight on
... ›
March 11, 2021 - Medical Devices + Diagnostics, European Union, Regulatory
Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 4 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
After having dealt with the issue when software may be considered a medical device according to its intended purpose (in part 2 ) and the implications of the new risk classification regime (in part 3 ), in this part 4 of our series on Software
... ›
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 Ph.D.
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
... ›
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 Ph.D.
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
... ›
February 26, 2021 - Medical Devices + Diagnostics, European Union, Regulatory
Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 3 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
Having shed light on the relevance of the intended purpose of a medical device when determining whether software qualifies as medical devices software (“MDSW”) under the new EU Medical Device Regulation 2017/745 (“MDR”) in part 2 of our series of articles , in this
... ›
February 24, 2021 - Medical Devices + Diagnostics, United Kingdom, Healthcare, Pharma, Regulatory
Life Sciences Regulatory Framework Becomes Law Post-Brexit
By: Jenny Galloway
Nearly one year after its introduction to the House of Commons, the Medicines and Medical Devices Bill 2019‑2021 (the Bill) was granted Royal Assent on 11 February 2021, becoming law as the Medicines and Medical Devices Act 2021 (the Act). The purpose of the Act is
... ›
February 19, 2021 - Medical Devices + Diagnostics, European Union, Regulatory
Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 2 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
In Part 2 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will soon govern medical devices software (“MDSW”) in the EU, we will shed further light on the expansion of the definition
... ›
February 12, 2021 - Medical Devices + Diagnostics, European Union, Regulatory
Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 1 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
The COVID-19 pandemic has significantly accelerated the adoption of digital health and virtual care in Europe, as well as globally. Fueled by technological advancement, including in the space of data analytics and AI, this trend is likely to continue. As with every health-related product
... ›
February 04, 2021 - United States, Litigation, Regulatory
EHR Vendor Settles Kickback Allegations to the Tune of $18.25 Million
On January 28, 2021, the United States’ Department of Justice (DOJ) announced an $18.25 million settlement with athenahealth Inc. (“Athena”) to resolve allegations that Athena violated the False Claims Act by paying impermissible kickbacks related to its electronic health records (EHR) product. At the
... ›

Topic Archives: Regulatory

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

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 5 of 6)

By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 4 of 6)

By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann

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

By: Jean Nguyen Ph.D.

Rare Disease: Sustained Progress in Development Regardless of the Pandemic

By: Catherine M. Polizzi Ph.D.

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 3 of 6)

By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann

Life Sciences Regulatory Framework Becomes Law Post-Brexit

By: Jenny Galloway

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 2 of 6)

By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 1 of 6)

By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann

EHR Vendor Settles Kickback Allegations to the Tune of $18.25 Million