Replacement Reagent and Instrument Family Policy Guidance for Industry and FDA Staff December 2003

GUIDANCE DOCUMENT

• Docket Number: FDA-2017-D-6765
• Issued by: Office of Medical Products and Tobacco, Center for Devices and Radiological Health

The Replacement Reagent and Instrument Family Policy (RR-Policy) is intended to provide you, the device manufacturer, with information about validating and documenting changes to cleared test systems that do not significantly affect the safety and effectiveness of the device.

This guidance document addresses only previously cleared reagents and instruments. It describes a mechanism for adding either a cleared reagent to a previously cleared instrument, or a new instrument family member to a previously cleared instrument family. OIVD has developed this alternative approach to assist you in meeting the 510(k) requirements for changes that might initially appear significant, but with proper validation it is demonstrated these changes do not significantly affect the safety and effectiveness of cleared devices. FDA believes that, before market introduction, if you evaluate your modified device against predefined acceptance criteria using a proper validation protocol, you establish sufficient control for assuring the safety and effectiveness for minor device modifications.

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All written comments should be identified with this document's docket number: FDA-2017-D-6765.