FOOD AND DRUG ADMINISTRATION ISSUES PROPOSED RULE: EFFECTIVE DATE OF REQUIREMENT FOR PREMARKET APPROVAL APPLICATIONS FOR BLOOD IRRADIATORS INTENDED TO PREVENT METASTASIS

WASHINGTON, March 18 -- Food and Drug Administration has issued a proposed rule called: Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended To Prevent Metastasis.

The proposed rule was published in the Federal Register on March 18 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) for blood irradiators intended to irradiate intraoperatively salvaged blood for cancer patients undergoing surgery to assist in prevention of metastasis, which are unclassified, preamendments devices. FDA is summarizing its proposed findings regarding the...