Department of Health and Human Services May 30, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is proposing to reclassify the full field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce full field digital x-ray images of the breast. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance document entitled ``Class II Special Controls Guidance Document: Full Field Digital Mammography System'' that would serve as the special control for the device, if FDA reclassifies this device type.

This notice announces a hospital's request for a waiver from entering into an agreement with its designated Organ Procurement Organization (OPO), in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.

The Food and Drug Administration (FDA) is issuing for public comment the recommendation of the Circulatory System Devices Panel (the Panel) to reclassify Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) to class II (special controls). The Panel made this recommendation after reviewing the reclassification petition submitted by Cook Group Inc. (COOK) and other publicly available information. FDA is also announcing for public comment its tentative findings based on the Panel's recommendation and other publicly available information. After considering any public comments on the Panel's recommendation and FDA's tentative findings, FDA will approve or deny the reclassification petition by order in the form of a letter to the petitioner. FDA's decision on the reclassification petition will be announced in the Federal Register. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance document that FDA intends will serve as the special control for this device type, if it is reclassified.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin.'' This guidance document describes a means by which tissue adhesive for the topical approximation of skin may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to reclassify these device types from class III into class II (special controls).