Stream: CCDA / FHIR mapping stream
Topic: FDA response regarding to Device question on AIDC and HRF
Ozlem Kurt (Sep 25 2020 at 15:11):
Hi @Brett Marquard ,
Please see the response below from FDA regarding to Device question we had during Connect-A-thon.
Thank you for contacting the Division of Industry and Consumer Education (DICE) at FDA's Center for Devices and Radiological Health (CDRH) DICE@fda.hhs.gov e-mail account.
The UDI rule does not specify what AIDC (automatic identification and data capture) technologies may be used, because the most appropriate technology will vary depending on the type of device and its intended uses, and because the available technologies are likely to evolve and advance over time. The AIDC technology may be a bar code or any other technology that conveys the UDI or DI in a form that can be entered into an electronic patient record or other computer system via an automated process.
If you have additional questions regarding UDI,or about the information found in the barcode, please submit them to the FDA UDI Help Desk.
Sincerely,
Consumer Safety Officer
Industry Team
Division of Industry and Consumer Education
Office of Communication and Education
Center for Devices and Radiological Health
U.S. Food and Drug Administration
Last updated: Apr 12 2022 at 19:14 UTC
