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 on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.