Replacement reagent and instrument family policy for in vitro diagnostic devices: guidance for industry and Food and Drug Administration staff
- Collection:
- Health Policy and Services Research
- 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, August 17, 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Diagnostic Test Approval Government Regulation Reagent Kits, Diagnostic United States United States. Food and Drug Administration
- Genre(s):
- Guideline Technical Report
- Abstract:
- In 2003, FDA issued an updated guidance on the “Replacement Reagent and Instrument Family Policy” for in vitro diagnostic (IVD) devices. The 2003 guidance described a mechanism for manufacturers to follow when applying an assay that was previously cleared based on performance characteristics when used with a specified instrument to an additional instrument that is either cleared or a member of an instrument family from which another instrument was previously cleared. Through the approach described in the 2003 guidance, manufacturers established sufficient control to maintain the level of safety and effectiveness demonstrated for the cleared device for these types of modified devices, when evaluated against predefined acceptance criteria using a proper validation protocol, without submission of a premarket notification (510(k)). For consistency of terminology with previous guidances and FDA-manufacturer communications, this updated guidance continues to use the terms “Replacement Reagent” and “Instrument Family Policy.” Within discussions in this guidance, generally the term “assay” is used instead of the term “reagent” to better represent typical scenarios, because most assays are currently comprised of multiple reagents.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (21 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918486678206676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918486678206676