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GUIDANCE DOCUMENT

Display Devices for Diagnostic Radiology Guidance for Industry and Food and Drug Administration Staff October 2017

Final
Docket Number:
FDA-2016-D-0270
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance is intended to apply to current technologies; however, FDA may request new or alternative test methods to fully evaluate the safety and effectiveness of future display technologies. In such instances, we recommend that you contact FDA to determine the appropriate regulatory pathway and testing for your device prior to submitting a premarket notification (510(k)). See Section III – Scope for more details on types of devices covered by this guidance document.


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:

Dockets Management
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-2016-D-0270.