- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
FDA has developed this guidance document for members of industry who submit and FDA staff who review non-clinical tests and labeling of femoral stem prostheses. The terms “you” and “your” in this document refer to members of industry, also known as sponsors, submitters, or applicants. The terms “we,” “us,” and “our” refer to FDA. You should use this guidance to assist you in determining the appropriate non-clinical information and non-clinical testing to submit in premarket notifications (510(k)s), premarket approval (PMA) applications, and investigational device exemptions (IDEs) that include a femoral stem prosthesis.
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-2020-D-0957.