Display Devices for Diagnostic Radiology
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
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-2016-D-0270.