On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major barrier to the use of real-world evidence (RWE) in medical device regulatory submissions. Namely, for certain types of medical device submissions, sponsors may not need to provide individually identifiable source data when using RWE.
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Breakthrough Devices Around the World: Opportunities and Challenges in the US and EU
By Morgan Lewis
The US Food and Drug Administration’s (FDA’s) Breakthrough Devices Program was established to facilitate earlier patient access to novel medical devices addressing serious health conditions, by offering prioritized review and enhanced communication with regulators. Despite its promise, only a small percentage of devices granted Breakthrough designation have achieved marketing authorization, reflecting persistent regulatory and evidentiary…
The European Commission Proposes Biotech Act to Support Development of Biotech Products
By Morgan Lewis
At the end of 2025, as part of a bundle of measures to make the EU health sector more innovative, competitive and resilient, the European Commission proposed the EU Biotech Act (the Act) aimed at repositioning the EU as a global biotechnology hub. It includes a wide range of proposals, such as access to funding,…
European Commission Issues Proposal to Simplify Medical Devices Regulations
By Morgan Lewis
In a pre-Christmas gift, the European Commission has adopted a proposal to simplify Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR): Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices . The key elements of the revisions are summarized in…
Agreement Reached on EU Pharma Package, but Questions Remain
By Morgan Lewis
Two and a half years after the initial proposal, agreement has been reached by the EU institutions on the so-called EU Pharma Package. The Package represents a comprehensive overhaul of the European Union’s pharmaceutical framework for medicinal products, which is currently based on legislation dating back to 2001.
New FDA Digital Health Pilot, Same FDA Enforcement Discretion
By Morgan Lewis
On December 8, 2025, FDA announced a pilot for certain digital health devices in connection with the Center for Medicare and Medical Innovation’s (CMMI’s) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) payment model.
Impacts of FDA’s Slimming of Biosimilar Requirements
By Morgan Lewis
FDA recently issued a new draft guidance titled Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies, which proposes omitting comparative efficacy studies (CES) where appropriate “based on the totality of the evidence” to instead rely only on analytical, PK/PD, and immunogenicity data to inform…
Date Set for Mandatory Application of European Database on Medical Devices
By Morgan Lewis
The European Commission, by its decision dated 26 November 2025, confirmed the functionality of four modules within the European database on medical devices (EUDAMED).
Major Overhaul of UK Rare Disease Regulation: MHRA Proposes Enhanced Framework
By Morgan Lewis
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced its intention to introduce sweeping reforms for accelerating rare disease therapy development and approval, with the aim to position the UK as a global leader in the field. The new framework will put in place flexible licensing for rare disease therapies with adaptive trial…
From Vulnerability to Violation: FDA Cybersecurity Requirements for Medical Devices and FCA Enforcement
By Morgan Lewis
In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (2025 Cybersecurity Guidance). This guidance updates the 2023 guidance of the same title with the agency’s interpretation of and compliance recommendations for new requirements for “cyber devices” under…