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CDRH Update May/June 2917




SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Use of  Electronic Records and Electronic Signatures in Clinical Investigations  under our regulations--Questions and Answers.'' The draft guidance provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other  interested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 The draft guidance expands upon recommendations in the guidance for industry entitled ``Part 11, Electronic Records;  Electronic Signatures--Scope and Application'' issued in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To ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 21, 2017.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.

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