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FDA 513(g) Cover Letter

E

ecmcc

Registered
#1
#1
Does anyone have a sample of a 513(g) cover letter? We do not know which classification our device would fall into. I'm just not sure what to say in the cover letter. How simple or elaborate does it need to be?

Any help you can give would be appreciated!
 
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Watchcat

Watchcat

Trusted Information Resource
#2
#2
I have no particular advice to give on 513(g) cover letters, because I've never submitted a 513(g). I have instead decided not to submit one on more than one occasion, and persuaded more than one client not to submit one. This isn't to say they are always a bad idea, but that they are not always the best way to go. And sometimes they can end up being a complete waste of time and money. In particular for someone who wants to "know" the classification of the device, given that 513(g) feedback is non-binding.

If you are not an RA professional experienced in working with FDA on such matters, my advice would be to consult with one before deciding to submit 513(g). There are several that hang out around these forums, including me.
 
E

ecmcc

Registered
#3
#3
Watchcat said:
I have no particular advice to give on 513(g) cover letters, because I've never submitted a 513(g). I have instead decided not to submit one on more than one occasion, and persuaded more than one client not to submit one. This isn't to say they are always a bad idea, but that they are not always the best way to go. And sometimes they can end up being a complete waste of time and money. In particular for someone who wants to "know" the classification of the device, given that 513(g) feedback is non-binding.

If you are not an RA professional experienced in working with FDA on such matters, my advice would be to consult with one before deciding to submit 513(g). There are several that hang out around these forums, including me.
Click to expand...
Thank you for that feedback. We are using an RA and they recommended we submit the 513(g) but have been completely unhelpful in drafting the cover letter. I've even asked point-blank what their service entails (I did not hire them, just managing the project at this point) and can't figure out what they're doing since everything is pushed off on me, they give vague advice on what to say in the cover letter (not specific to our product), and they won't even provide a SAMPLE of a cover letter. Incredibly frustrating.
 
Ajit Basrur

Ajit Basrur

Staff member
Admin
#5
#5
ecmcc said:
Does anyone have a sample of a 513(g) cover letter? We do not know which classification our device would fall into. I'm just not sure what to say in the cover letter. How simple or elaborate does it need to be?

Any help you can give would be appreciated!
Click to expand...
I have not filled in a 513(g) to get a device classification and instead emailed to DICE for information. You would have reviewed the below Guidance Document on 513(g) but in case, you havent, pls see the link below.

FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff

Take a look esp. for sections III and V

III. Obtaining Information About a Device
A. General Information You can obtain information about device classification and regulatory requirements applicable to a type of device in several ways. FDA's device regulations may be found at 21 CFR parts 800 - 898; the regulations classifying device types are located at 21 CFR parts 862-892. The CDRH classification resources3 on the CDRH web site can help you quickly ascertain how your device type may be classified. You can also obtain information about the regulatory requirements that may apply to a particular type of device on FDA’s web site (see resources below).

V. Contents of a 513(g) Request for Information
The 513(g) Request for Information should contain the following: • a cover letter, • a description of the device, 12 • a description of what the device is to be used for, and • any proposed labeling or promotional material for the device and, as applicable, any labeling or promotional material of a similar, legally marketed device, if available. Cover Letter Your cover letter should identify your request as a “513(g) Request for Information.” Your cover letter should include:
• the date of the request,
• the name of the device,
• your specific question(s) concerning the class in which a device has been classified and/or the regulatory requirements applicable to a device,
• the requestor’s name, address, telephone number, fax number, and email address, and
• the 513(g) requestor’s signature.
 
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