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Compliance In Focus
Posted by John Lehmann on Fri, Mar 30, 2012

Do You Agree? Is the 510(k) a Pathway to Peril?

According to Ed Markey, D-Mass, the FDA needs stricter regulation of medical devices and to510(k): Dangerous Loophole end the 510(k) pathway to approval. As a result of this belief, the congressman introduced the Safety of Untested and New Devices Act (SOUND) to close the 510(k) pathway, or as Markey refers to it, the regulatory loophole. This act aims to “ensure that new medical devices are not cleared by the FDA if they are based on a product that was recalled because it caused serious harm to patients,” according to the press-release.

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 predicate;
  • 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 problems.

Markey has also released a report titled, “Defective Devices, Destroyed Lives: Loophole Leaves Patients Unprotected From Flawed Medical Devices.” In this document, Markey details:

• Background on 510(k)Clearance
• A Dangerous Loophole
• The SOUND Devices Act
• Consequences for Patients & Patient Stories

This probably won’t be the last we hear of the SOUND Act. In fact, Markey is fighting to include the bill in the FDA legislation that Congress will consider this summer as part of the Medical Device User Fee Act (MDUFA). More information on MDUFA is available in our previous blogs.

Your thoughts on the 510(k) pathway? Do you believe it’s an important pathway to quickly bring life-saving innovations to patients? Or, do you believe it is a dangerous backdoor to approval? 

Photo Credit:  Zahoяí's

 

Topics: Ed Markey, D-Mass, 510(k)

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