WASHINGTON, D.C. – Janet Trunzo, executive vice president, technology and regulatory affairs, for the Advanced Medical Technology Association (AdvaMed), released the following statement on the introduction of the “Medical Device Patient Safety Act” by Sens. Grassley (R-Iowa), Kohl (D-Wis.) and Blumenthal (D-Conn.):
“AdvaMed shares Sens. Grassley, Kohl and Blumenthal’s interest in ensuring American patients continue to have access to safe and effective medical devices.
“We believe expanding the FDA’s authority to require post-market studies as a condition of 510(k) clearance is unnecessary given the agency already has broad authority to require manufacturers to conduct post-market studies for higher-risk devices cleared via 510(k).
“Regarding the bill’s provisions to implement recent Government Accountability Office’s (GAO) recommendations to improve the FDA’s handling of medical device recalls, we believe, consistent with GAO recommendations, the FDA could do more to enhance the clarity and consistency of its recall process, and we are pleased that the agency has a number of initiatives underway in this area.
“It is important for the America public to realize that the medical technology industry has a well-documented safety record. Several recent studies have shown that for the vast majority of products cleared by the FDA, less than 0.5 percent are involved in a serious recall, a point GAO has emphasized as well. In addition, nothing in the GAO’s recommendations suggest a lack of diligence or inadequacy in medical technology companies’ implementation of recalls.
“AdvaMed looks forward to working with Sens. Grassley, Kohl and Blumenthal, other members of Congress from both sides of the aisle, and the FDA on this important issue.”
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.
Mark E. Brager
Associate Vice President, Communications