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So today, Feb 1st, is supposed to be the day Class II Med Device manufacturers can request a GUDID Account.  Just tried, and got the same response of "We are only accepting accounts for Class III labelers at this point."  Grrrrr...so annoying! Anyone have any insider info on when we can expect to be let in?

Thanks!

I have requested one as well on 1st February but it resulted into the reply as they are not accepting the application for class II device. Can you please specify what exactly you mentioned in your email for submitting GUDID account request.

Thanks

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I attached an electronic sticky note to the form when it asked if I was a class III labeler that said,

"This form should be for class II devices, and we are a class II device manufacturer." and I checked the box No.

Then the email I wrote to FDA said,

I am requesting a pre-production account for HL7 SPL submission option for class II devices. I waited until after Feb. 1 and was still given the Class III form. Please let me know if you need me to fill in a new form.

I was given access within about an hour.

I wonder i have the same form. would you like to share the form you received from FDA?

Thanks

My form is dated January 2015, Version 5. 

It contains the statement, "At this time, we are only accepting requests from labelers of class III medical devices, devices licensed under the public Health Service Act (PHS Act), Implantable, Life-Supporting, or Life Sustaining devices." about half way down on the form.  That was where I put the sticky note. 

The FDA announced they would accept GUDID Account Requests for Class II Labelers beginning Monday Feb 1, but the UDI Help Desk email response was not updated through at least Tuesday Feb 2 noontime. As of now, Thursday Feb 4, the UDI Help Desk email response and the Account Request form have both been updated. Looks like the FDA is ready for Class II business!

UDI Help Desk email …

“… currently ONLY open to labelers of class III devices, class II devices, devices licensed under the PHS Act, and devices that are implantable, life-supporting, or life-sustaining.”

The GUDID Account Request form has the following noteworthy changes in the new Version 6:

• GUDID is now open to Class II labelers …“At this time, accounts will be created only for labelers of: class II devices; implantable, life-supporting or life-sustaining devices; class III devices; and devices licensed under the Public Health Service (PHS) Act.”
• When applying for the SPL Submission Option, the form now provides a dedicated bullet selection to initially request an account in the “HL7 SPL Pre-production” environment and a separate bullet selection when using the form a second time to request an account in the “HL7 SPL Production” environment.
• The request for an account in the “HL7 SPL Production” environment now requires an entry of the Help Desk Case # that indicates that SPL testing was completed and verified.
• To verify a marketed device, the new form allows entry of the FDA Listing Number for a 510k Exempt device, instead of entry of an Premarket Application Number (PMA, 510k, etc.).

Gary Saner

gsaner@reedtech.com, www.Reedtech.com  

Gary,

Great news!

Thank you so much for the update!