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Compliance In Focus
Posted by John Lehmann on Wed, Jun 19, 2013

AdvaMed: Don’t Change 510(k) Rules

Don’t Change 510(k) RulesAdvaMed is pushing back on an initiative in Congress to have the FDA to tighten policies for approving modifications of on-the-market medical devices.  In an article in FierceMedicalDevices, AdvaMed contends there is nothing wrong with the current 510(k) program.  AdvaMed contends the system has worked well for 16 years, so no changes are needed.

Under the FDA’s current rules, medical device makers only have to re-apply for 510(k) clearance when changes will “significantly affect the safety or effectiveness of the device.” 

The industry maintains that the manufacturer is the best qualified to decide when device changes should merit re-submission.  They also contend that the FDA can rely on its warning letter system to force manufacturers to obtain another premarket clearance. 

Since Congress has asked the FDA to change the system, there will be modifications to the existing regulations. AdvaMed has issued a whitepaper that recommends only targeted changes to the 1997 rules.  It recommends:

  • The FDA set an established procedure for medical device manufacturers to evaluate what constitutes a significant change
  • Make explicit the process for testing and validating device modifications

There has been growing concern by lawmakers and some consumer groups regarding safety issues with FDA-cleared technologies.  Do you share these groups concerns or side with the industry’s position in making modest reforms to the 510(k) approval process?

Share your thoughts below.

Photo Credit:bcymet

510(k) Current Status and Considerations

Topics: AdvaMed, FierceMedicalDevices, FDA, 510(k)

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