Summary
New FDA documentation requirement for Class I medical devices: sellers must submit screenshots of FDA Establishment Registration and Device Listing from FURLS, including establishment name, address, operation type, and validity confirmation. All documents must be authentic and unmodified.
Why it matters
Sellers of baby medical devices (e.g., toothbrushes, nasal aspirators, breast pumps) must now obtain FDA registration proof and FURLS screenshots before qualification. Non-compliance blocks category authorization and product listings. Requires direct FDA system access and submission management.
Recommended action
Review FDA FURLS registration status; gather required screenshots showing Establishment Registration, Device Listing, and establishment details. Submit via Qualification Center. Verify screenshots are unmodified originals from official FDA website. Allow 30 days for submission and approval.
A screenshot of the FDA Establishment Registration number (21 CFR Part 807) from the FDA Unified Registration and Listing System (FURLS)
Screenshots must clearly show that they were taken from the official FDA FURLS website
All documents must be authentic and remain in their original (unmodified) format
No content was removed in this update.
Affects: Seller, Listing