SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Use of Electronic Records and Electronic Signatures in Clinical Investigations under our regulations--Questions and Answers.'' The draft guidance provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic records and electronic signatures under our regulations in clinical investigations of medical products. The draft guidance expands upon recommendations in the guidance for industry entitled ``Part 11, Electronic Records; Electronic Signatures--Scope and Application'' issued in August 2003 (referred to as the 2003 part 11 guidance) for recommendations that pertain to FDA-regulated clinical investigations conducted under our regulations.
To ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 21, 2017.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices.'' The purpose of this workshop is to discuss potential scientific and regulatory challenges associated with developing traditional antimicrobial susceptibility testing (AST) devices and devices that detect antimicrobial resistance markers by molecular or novel diagnostic technologies, and to provide an overview of relevant provisions of the 21st Century Cures Act that may impact the development of such devices. Public input and feedback gained through this workshop will aid in the development of science-based approaches to regulatory decisionmaking regarding traditional and novel AST devices. Further, this workshop will explore opportunities for the efficient development and evaluation of AST devices, which may lead to better patient care and reduce antimicrobial resistance through improved antibiotic stewardship. DATES: The public workshop will be held on September 13, 2017, from 8:30 a.m. to 5 p.m.
SUMMARY: The Food and Drug Administration (FDA or Agency) has determined that it is necessary for manufacturers of certain reusable medical devices to include in their premarket notifications (510(k)s) instructions for use which have been validated and validation data regarding cleaning, disinfection, and sterilization, for which a substantial equivalence determination may be based. This notice includes a list of these reusable devices that will require validated instructions for use and validation data in their premarket notification. FDA is publishing this list in accordance with the requirements established by the 21st Century Cures Act. This action ensures that the premarket requirements for these device types are clear and predictable which facilitates more efficient review of these 510(k)s. DATES: These actions are effective on August 8, 2017.
· Federal Register: Humanitarian Use Devices; 21st Century Cures Act; Technical Amendmen
The Food and Drug Administration (FDA) is amending regulations to reflect changes recently enacted into law by the 21st Century Cures Act. Specifically, certain requirements related to humanitarian device exemptions (HDEs) and institutional review boards (IRBs) for devices have changed. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended.