> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Medical Device Pre-Cert FAQs
- URL: https://www.fdaweb.com/medical-device-pre-cert-faqs/
- Published: 2017-08-10T12:00:00.000Z
- Updated: 2026-09-14T22:40:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139350

CDRH has released frequently asked questions (FAQs) about the new medical device pre-certification pilot program. The [document](https://www.fda.gov/MedicalDevices/DigitalHealth/ucm570617.htm?ref=fdaweb.com) covers 13 questions about eligibility for the program and how it will operate.