FDA Drafts Guidance for Heart Valve Applications

January 20, 2010—The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health has posted a draft guidance document for industry and FDA staff regarding investigational device exemption (IDE) and premarket approval (PMA) applications for heart valves. Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

The draft document states that this guidance is intended to provide recommendations for the preparation of IDE and PMA applications for replacement heart valves that are not allograft heart valves or more than minimally manipulated allograft heart valves. The guidance describes the FDA's recommendations about manufacturing, preclinical in vitro bench testing, preclinical in vivo studies, clinical investigations, and labeling that are different from or in addition to the recommendations of the International Organization for Standardization. The guidance is intended for use by members of industry and FDA staff members who prepare or review replacement heart valve IDE and PMA applications.

According to the FDA, the guidance applies to percutaneously delivered valves; however, different or additional in vitro, in vivo preclinical, and clinical studies may be appropriate for such devices, depending on the specific device design, the proposed indications for use, and the results of risk analysis. The FDA recommends that interested parties contact the Circulatory and Prosthetics Devices Branch to discuss planned submissions for percutaneously delivered valves.

This draft guidance, when finalized, will represent the FDA's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind the FDA or the public. An alternative approach can be used if the approach satisfies the requirements of the applicable statutes and regulations.