United States - Top Medical Device Alerts

Draft Guidance for Industry on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers This document guides sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on using electronic systems, electronic records, and electronic signatures in clinical investigations of medical products. In addition, the guidance provides recommendations regarding the requirements, including those under 21 CFR part 11 (part 11), under which the FDA considers electronic systems, electronic records, and electronic signatures trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act On December 29, 2022, the Consolidated Appropriations Act, 2023 ("Omnibus") was signed into law. Section 3305 of the Omnibus — "Ensuring Cybersecurity of Medical Devices" —amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 524B, Ensuring Cybersecurity of Devices. The Omnibus states that the amendments to the FD&C Act shall take effect 90 days after the enactment of this Act on March 29, 2023. Therefore, as provided by Omnibus, the cybersecurity requirements do not apply to an application or submission submitted to the Food and Drug Administration (FDA) before March 29, 2023.

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions Draft Guidance for Industry and Food and Drug Administration Staff This draft guidance is intended to provide a forward-thinking approach to promote the development of safe and effective medical devices that use ML models trained by ML algorithms. In addition, this draft guidance proposes a least burdensome approach to support iterative improvement through modifications to an ML-DSF while continuing to provide a reasonable assurance of device safety and effectiveness. As such, this draft guidance demonstrates the FDA’s broader commitment to developing innovative approaches to the regulation of device software functions as a whole. Specifically, this draft guidance provides recommendations on the information to be included in a Predetermined Change Control Plan (PCCP) provided in a marketing submission for an ML-DSF.

A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry This guidance provides information on risk-based approaches to monitoring the conduct of clinical investigations of human drug and biological products, medical devices, and combination products. In addition, this guidance contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results.

CDRH Announces Radiation Sterilization Master File Pilot Program CDRH is announcing a Radiation Sterilization Master File Pilot Program to help companies advance alternative and innovative ways to sterilize approved medical devices, including changing radiation sources, in the least burdensome regulatory approach. The pilot program is voluntary and intends to allow companies that sterilize single-use PMA-approved medical devices using gamma radiation or ethylene oxide (EtO) to submit master files when making certain changes.