Recommendations for dual 510(k) and CLIA waiver by application studies: guidance for industry and Food and Drug Administration staff

Recommendations for dual 510(k) and CLIA waiver by application studies: guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Devices and Radiological Health, February 26, 2020
Language(s):
English
Format:
Text
Subject(s):
Clinical Laboratory Techniques
Device Approval
Reagent Kits, Diagnostic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
The purpose of this guidance is to assist manufacturers in using the Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application pathway. It describes study designs for generating data that may support both 510(k) clearance and CLIA waiver. Use of the Dual 510(k) and CLIA Waiver by Application pathway is optional; however, FDA believes this pathway is in many instances the least burdensome and fastest approach for manufacturers to obtain a CLIA waiver at the same time as 510(k) clearance for new In Vitro Diagnostic (IVD) tests. FDA believes increased use of this pathway will speed up the process of bringing simple and accurate IVD tests to CLIA-waived settings, which will better serve patients and providers.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (10 pages)).
NLM Unique ID:
101772620 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/101772620