- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Medical Products and Tobacco, Center for Tobacco Products
This guidance provides information for those submitting reports concerning substantial equivalence under section 905(j) of the FD&C Act, including FDA’s interpretation of the statutory sections related to substantial equivalence and recommendations on the form and content of section 905(j) reports.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2010-D-0635-0001.