My IDSA Contact Us
IDSA NewsPrint-Friendly Newsletter
Forward to a Friend
Search Back Issues
 
Education & Training Resources Practice Guidelines Journals & Publications Policy & Advocacy Meetings About IDSA
September 2014
Policy and Advocacy
IDSA Submits Comments to FDA on Draft Guidance on Diagnostics
The Food and Drug Administration (FDA) recently issued draft guidance important to the development of new diagnostic tests. IDSA submitted comments to the first FDA draft guidance that calls for an expedited approval process for medical devices that can meet unmet medical needs.  IDSA praised the agency's new provisions for diagnostic device trials, such as the use of banked samples from previous studies as well as contrived samples to test the clinical effectiveness and safety of diagnostics for rare diseases. IDSA believes this guidance will greatly facilitate the rapid development and review of innovative diagnostics and significantly impact patient care.

IDSA also submitted comments (PDF) to a second FDA draft guidance that allows small clinical studies in the approval process of diagnostics that address unmet medical needs. Acknowledging that smaller trials may leave more uncertainty about the risks and benefits of these tests, the guidance indicates that additional data can then be collected post-approval to provide information about the diagnostic’s efficacy and appropriate use in real-world settings. IDSA supports the provisions for post-market data collection that will allow novel tests to reach patients more rapidly.



< Previous Article | Next Article >

Post a comment

Your name:

Your comment:


Patient Care and Science
Sanford Guide Releases Mobile App for Lab Diagnosis of Infectious Diseases
NVAC Standards for Adult Immunization: What Do They Mean for the ID Specialist?
HCV Treatment Guidance Now Includes Information on Prioritizing Patients
Clinical Practice Management
New Resources on Co-management Agreements and Antimicrobial Stewardship Now Available
IDSA, HIVMA Appeal Medicaid Restrictions on Who Treats HCV
Policy and Advocacy
IDSA Convenes New National Stakeholder Group on Antimicrobial Resistance
Federal Funding Process Stalled Just Weeks Ahead of New Fiscal Year
Health Groups Share Federal Funding Experiences with Congress
Advocacy on New Antibacterial Drug Pathway Continues in the House
IDSA Submits Comments to FDA on Draft Guidance on Diagnostics
Global ID
Highlights from 20th International AIDS Conference
Education and Resources
Concerns Regarding Changes to MOC Requirements Shared with ABIM
IDSA Education and Research Foundation Launches New Website
Sign Up for OFID Table of Contents Alerts
You and Your Colleagues
In Memoriam: Gene H. Stollerman, MD, FIDSA (1920-2014)
IDSA Announces 2014 Fellows
Members on the Move
New Members
Top Stories
Presidentís Message: With the Spotlight on Drug Resistance, Itís Time for the ID Specialistís Role in Stewardship to Shine
IDSA Provides Ebola Resources for ID Clinicians
Countdown to IDWeek 2014
IDSA Journal Club
IDSA | 1300 Wilson Blvd., Suite 300 | Arlington, VA 22209 | Phone: (703) 299-0200
To ensure delivery, please add 'info@idsociety.org' to your email address book or Safe Sender List.
If you are still having problems receiving our communications,
see our white-listing page for more details.