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GUIDANCE DOCUMENT

Non-clinical Information for Femoral Stem Prostheses Guidance for Industry and FDA Staff September 2007

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center 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.

Submit Comments

Submit Comments Online

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:

Dockets Management
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.

 
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