FDA and International Counterparts Release Best Practices for Machine Learning in Medical Device Development

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 …›

FDA Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products

On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “Interpreting Sameness of Gene Therapy Products under the Orphan Drug Regulations.” The guidance finalizes the January 2020 draft guidance and provides FDA’s current perspective on certain criteria that …›

May 20, 2021 - Regulatory, United Kingdom

UK’s new emissions trading scheme hosts first auctions

Stephanie Pong, London trainee solicitor contributed to the writing of this article. On January 1, 2021, the UK launched its very own emissions trading scheme (the “UK ETS”) exercising its autonomy since departing the EU. Under this scheme, companies operating in certain sectors can trade …›

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

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 …›

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

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 …›

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Union, this post will discuss some of the similarities between FDA’s Clinical Decision Support (“CDS”) Software Draft Guidance (together the “CDS Draft Guidance”) and the MDR. …›

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

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 …›

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

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 as …›