New Tool: ProSource
Checkout our packaging and processing solutions finder, ProSource.

AdvaMed Statement on Senate "Medical Device Patient Safety Act"

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.”
Discover Our Content Hub
Access Healthcare Packaging's free educational content library!
Read More
Discover Our Content Hub
How to Honor a Leader
Induction into the Packaging & Processing Hall of Fame is the highest honor in our industry. Submit your leader to be considered for the Class of 2024 now through June 10th. New members will be inducted at PACK EXPO International in Chicago.
Read More
How to Honor a Leader