Guidance For Industry And Food And Drug Administration Staff - U.s. Department Of Health And Human Services - 2012 Page 10
ADVERTISEMENT
1
2
3
4
5
6
7
8
9
10
11
12
13Contains Nonbinding Recommendations
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,
5
· the requestor’s name, address, telephone number, fax number, and email address,
and
· the 513(g) requestor’s signature.
Description of the Device
As applicable, the description of the device should include:
· a list of materials and components used in/with the device,
6
· photographs, engineering drawings, and/or samples of the device,
· a summary of the device’s operational principles,
· a description of the type and amount of energy to be used or delivered by the device,
and
· a description of similar devices in commercial distribution in the United States, if
available.
Device Uses
You should include the following information:
· the disease or condition with respect to which the device is to be used
· prescription versus over-the-counter use,
· part of the body or type of tissue applied to or interacted with,
· frequency of use,
· physiological purpose (e.g., removes water from blood, transports blood, etc.),
· patient population; and
· any other labeling information related to the patient use of the device.
5
You should provide the contact information for a single point of contact. The contact information should be
associated with the person submitting the Request for Information as the term person is defined in section
201(e) of the FD&C Act.
6
Any sample device can be returned at the request of the submitter.
7
ADVERTISEMENT
0 votes
Related Articles
Related forms
Guidance For Industry - Assessment Of Abuse Potential Of Drugs - U.s. Department Of Health And Human Services - 2017
Legal
Form Acf-196t - Administration For Children And Families - U. S. Department Of Health And Human Services
Legal
Form Nih 2762-3 - Undergraduate Scholarship Program (ugsp) - Academic Enrollment Certification And Service Obligation Deferment Request - U.s. Department Of Health And Human Services
Legal
Related Categories
Parent category: Legal