Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions
Submit Comments by 06/18/2019
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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When finalized, this draft guidance document will provide detailed recommendations for manufacturers about the information that should be included in premarket submissions (i.e., premarket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.