Congressman Edward J. Markey (D-Mass.) has released a new report titled “Defective Devices, Destroyed Lives: Loophole Leaves Patients Unprotected from Flawed Medical Devices”. Rep. Markey’s report brings to light a loophole that requires the Food and Drug Administration (FDA) to clear medical devices that demonstrate their similarity to an earlier model, even if that previous model was recalled for a major safety defect.
Reps. Markey, Henry A. Waxman (D-Calif.), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.) introduced H.R. 3847, the Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act).
This bill closes the loophole in the device approval process known
as the 510(k) by ensuring that a new device is not cleared by the FDA if
it is based on an earlier product that was pulled from the market for
causing serious harm to patients.
The SOUND Devices Act will give the FDA the
ability to reject a device application based on a predicate that has
been recalled or is in the process of being removed from the market for
major safety problems.
Specifically, the SOUND Devices Act:
• Provides FDA the ability to reject a device application based
on a predicate that has been recalled or is in the process of being
removed from the market for major safety problems;
• Requires companies to inform FDA if any products in their new
device’s “predicate lineage” have caused serious harm and to explain how
theirs avoids past mistakes;
• Instructs FDA to maintain a publicly accessibly database that
companies can use to determine whether a device can be used as a
• Strengthens reporting requirements so that companies and the
public can easily determine why a recall occurred (information that is
often missing in the case of voluntary recalls);
• Calls for FDA to review the safety of high-risk devices if a
product in their “predicate lineage” is recalled due to major safety