Issue Date: September 17, 2007
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket,
Status: Final
Non-clinical Information for Femoral Stem Prostheses: Guidance for Industry and FDA Staff
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.
Download the Guidance Document
