Do Proposed Changes to FDA’s Medical Device Review Process Make Sense?
02-17-2012
By John J. Smith, Partner, Hogan Lovells
From congressional watchdog reports urging reform, to the medical device industry’s concern over delayed market entry, the FDA’s 510(k) review process is under fire again.
House Democrats have introduced a bill to close a provision in the fast-track approval process they say is putting consumers at risk. Under the existing premarket notification process, a medical device can win approval even if its design is similar to that of a product that has been previously recalled. The proposed Safety of Untested & New Devices Act of 2012 (SOUND Devices Act) would authorize the FDA to block this type of premarket clearance and require the FDA to determine whether previously-approved devices had recalls in their “device lineage,” the family tree from which the device originates.
In a statement announcing the proposed legislation, Rep. Edward Markey (D-Mass.) cites the case of transvaginal mesh implants, which were cleared by the 510(k) system without undergoing human testing. Those implants were later found to be defective and were recalled in 1999.
But while attractive in theory, proposals calling for recalls of medical devices based on previous recalls of other products would be difficult to implement and likely have little impact on device safety. In fact, the overwhelming majority of device recalls are attributable to manufacturing issues, not design flaws. Asking a sponsor to explore such issues simply adds an additional administrative burden and may not provide a full picture of recall details. Alternatively, simply disqualifying a device based on a prior recall of another product may substantially overstate the risk that the recall actually represented.
The FDA already employs a much better strategy. The agency now monitors device recalls across multiple products, identifies potential issues, and raise questions when sponsors seek clearance of new products with similar characteristics. Initiating the kind of change advocated by the proposed SOUND Devices Act would complicate matters without adding to consumer protection.
What are your thoughts on the proposed SOUND Devices Act? Do you believe the bill is too far-reaching? How would the legislation affect your business if passed? Let us know your thoughts below.
John J. Smith’s practice focuses on assisting medical device companies in addressing U.S. Food and Drug Administration (FDA) regulatory issues. You may contact him at (202) 637-3638 or john.smith@hoganlovells.com.
