As we kick off 2022, several recent developments from FDA suggest that this year could be pivotal for the Agency’s digital health priorities.  From new FDA offices and artificial intelligence guidance, to FDA’s user fee commitments and must-pass legislation in Congress, this post outlines five key issues to watch in 2022 related to FDA and

On June 22, 2021, Congressional leaders Diana DeGette (D-DO) and Fred Upton (R-MI) released a bipartisan follow-up to the 2016 21st Century Cures Act“Cures 2.0”—a “discussion draft” at this stage—is intended to build upon the Cures Act.  The draft lays out several notable policies related to digital health, real-world data/evidence (RWD/E), and

FDA has long recognized the significant potential of artificial intelligence- and machine learning- (AI/ML-) based software as a medical device (SaMD) to transform health care as well as the unique challenges presented by AI/ML-based software under the Agency’s traditional medical device regulatory framework.  On January 12, 2021, FDA issued the Artificial Intelligence/Machine Learning (AI/ML)-Based Software

On July 28, 2020, FDA announced the publication of a final guidance on Multiple Function Device Products: Policy and Considerations that outlines FDA’s evolving approach to the regulation of multiple function device products, including software.

The concept of “multiple function” products was introduced by the 21st Century Cures Act (“Cures Act”) of 2016, which

Software development can teach us a lot about streamlining the research and development (R&D) process in other industries.  “Agile development”, or the process of dividing up an R&D project into smaller, more iterative segments instead of planning the entire project at its inception, is a hallmark of the software development process.  In a recently published

The following guidance could be relevant to manufacturers of software as a medical device (SaMD).  The recently-enacted Coronavirus Aid, Relief, and Economic Security Act (CARES Act) added new section 506J to the Federal Food, Drug, and Cosmetic Act (FDCA). This section requires manufacturers of certain devices to notify FDA of an interruption or permanent discontinuance

Product liability considerations are not likely the first concerns that spring to mind for the many companies working to develop digital health countermeasures and other products related to COVID-19.  Yet even while putting together solutions on an accelerated timeline, there are some straightforward actions that companies can take that may reduce litigation risk down the

On February 27, 2020 NHSX, the technology and digital unit of the NHS, published its draft Digital Health Technology Standard (the “Standard”) for consultation to stakeholders in the digital health space (the “Consultation”). The Consultation is open until 22 April, 2020 (and is available here).

The Standard, which is based on existing industry and health standards, is intended to streamline how digital health technologies are reviewed and commissioned by the NHS and social care.

Continue Reading NHSX Consults on Draft Digital Health Technology Standard

The EU’s regulatory rules for medical devices are due to change on 26 May 2020, when the new Medical Device Regulation (“MDR”)[1] comes into effect.  The regime for in vitro diagnostic devices will change two years later from 26 May 2022 when the In Vitro Diagnostic Devices Regulation (“IVDR”)[2] will apply.

In advance of these changes, the EU Medical Device Coordination Group (“MDCG”) has recently published guidance on the Qualification and Classification of Software in the MDR and IVDR (the “Guidance”).

The aim of the Guidance is to assist manufacturers with interpreting the new Regulations to assess whether their software meets the definition of a medical device or an in vitro diagnostic device (i.e., “qualification”); and if so, what regulatory class the software would fall under (i.e., “classification”).

The MDCG is a coordination group established under Article 103 of the MDR, comprising up to two medical device experts from each EU Member State.  Its key functions include contributing to the development of guidance to ensure effective and harmonized implementation of the EU’s new medical device rules.  The Guidance is not legally binding nor does it necessarily reflect the official position of the European Commission.  However, given the MDCG’s important role in the regulatory landscape, the Guidance is likely to be highly persuasive.

Continue Reading EU Medical Device Coordination Group Publishes Guidance on the Qualification and Classification of Software under Upcoming Medical Device Regulations

On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies. These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device. In parallel, FDA also updated four previously final guidance documents to ensure alignment with the new approaches being adopted by the Agency.

As background, FDA issued draft guidance documents in December 2017 that sought to implement section 520(o)(1) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), which was enacted by Congress in the 21st Century Cures Act of 2016 (the “Cures Act”). Those guidance documents raised a number of issues that we discussed on this previous alert.

After receiving comments from stakeholders, the Agency responded by issuing: (i) a revised draft guidance document for clinical decision support (CDS) software (“Clinical and Patient Decision Support Software” or the “CDS Draft Guidance”) and (ii) a final guidance document for other software functions exempted by the Cures Act (“Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act” or the “Software Policies Guidance”).

Here are key takeaways on FDA’s newly-issued guidance:
Continue Reading FDA Issues Updated Guidance on the Regulation of Digital Health Technologies