URGENT: EMAIL FROM FDA ON UDI GUDID REPORTING

Dear Members,

It appears that the Food and Drug Administration (FDA) has sent out an email to every FDA-registered medical device company that has yet to report its Unique Device Identifiers (UDIs) into the GUDID database, including those that are legally exempt from the reporting requirement. If you received one of these emails, and your company is involved with spectacle frames, Plano sunglasses, over-the-counter reading glasses, or other over-the-counter devices that can be sold without a prescription, then we suggest you take the following steps:

1. Send the following message to the UDI help desk ( DO NOT reply to the email they sent you). Go here: https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/fda-udi-help-desk. Click on the rectangular box that says, “Contact the FDA UDI Help Desk.” That will pull up an on-line template that you can fill out. In the comments section, cut and paste the following message in step 2. Make the necessary corrections to the highlighted areas to reflect your company and the types of devices you have listed with the FDA.

2. Dear FDA UDI Help Desk,

We have received an email from the FDA regarding GUDID registration for our listed devices. Our company, Company Name, lists the following Class I medical devices: 1) spectacle, magnifying (i.e., over-the-counter reading glasses); 2) frame, spectacle and 3) sunglasses (i.e., non-prescription). Those Class I devices, however, meet the definition of “consumer health products” as set out in the FDA guidance document titled: Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices, (July 25, 2022) in that they are all Class I, 510(k)-exempt devices sold to consumers “over-the-counter” without the need for a prescription. Therefore, according to the FDA’s guidance document, Company Name need not list these devices in the GUDID database.

Any questions about this issue can be directed to Rick Van Arnam, The Vision Council’s regulatory affairs counsel, at rvanarnam@barnesrichardson.com or to Omar Elkhatib, The Vision Council’s Senior Manager of Government Relations at oelkhatib@thevisioncouncil.org.