Draft Guidance for Industry on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers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.
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.
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