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GUIDANCE DOCUMENT

Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions Guidance for Industry and Food and Drug Administration Staff April 2019

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions

Docket Number:
FDA-2019-D-1470
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

When finalized, this draft guidance document will provide detailed recommendations for manufacturers about the information that should be included in premarket submissions (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications and De Novo requests) for devices that include quantitative imaging functions.  In general, manufacturers preparing premarket submissions for devices that include quantitative imaging functions should provide performance specifications for the quantitative imaging functions, supporting performance data to demonstrate that the quantitative imaging functions meet those performance specifications, and sufficient information for the end user to obtain, understand and interpret the values provided by the quantitative imaging functions.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-1470.