New legislation introduced by Sen. Scott Brown (R-Mass.) to improve the de novo classification process for medical technology received kudos from AdvaMed as did the “Medical Device Patient Safety Act” by Sens. Grassley (R-Iowa), Kohl (D-Wis.), and Blumenthal (D-Conn.).

Addressing the legislation to improve the de novo classification process, AdvaMed President and CEO Stephen J. Ubl, says, “We applaud the introduction of S. 1943 to streamline the de novo classification process for novel low- to moderate-risk medical technology. We strongly support the need to strengthen and optimize the de novo process through a well-defined regulatory pathway, which will benefit the agency, industry, and patients. This bill saves time and resources by eliminating the requirement that companies submit a 510(k) for technologies and receive a ‘Not Substantially Equivalent’ determination when they know, going into the classification, that there is no predicate technology. Eliminating this unnecessary step will make the process more efficient. We believe the underutilized de novo process has the potential to play a key role in the regulation of medical devices.”

And in response to the “Medical Device Patient Safety Act,” AdvaMed Executive Vice President of Technology and Regulatory Affairs Janet Trunzo, says, “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.”

Trunzo adds, “It is important for the American 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% are involved in a serious recall, a point GAO has emphasized as well. In addition, nothing in the GAO’s recommendations suggests a lack of diligence or inadequacy in medical technology companies’ implementation of recalls.”