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Guest Blog: FDA's Off-Base New Guidance on 510(k)s Will Be a Headache for Device Makers
The guidance, on submitting 510(k)s for changes to an existing device, will substantially increase the number of submissions required and cause significant delays for the release of all medical device improvements.
August 26, 2011
2 Min Read
FDA’s new guidance on submitting 510(k)s for changes to an existing device will substantially increase the number of submissions required and cause significant delays for the release of all medical device improvements. This guidance, titled “Deciding When to Submit a 510(k) for a Change to an Existing Device," suggests a new 510(k) is needed whenever a “safety” complaint is fixed, a new alarm is implemented, or a “known failure mode” is eliminated. This is just part of the huge scope change from the previous 1997 version of this document. Unless the industry can mount a substantive challenge to this guidance, it has the potential to significantly slow an already lengthy review process.
The FDA is really out of line on this one; its interpretation of changes that “could significantly affect the safety or effectiveness of the device” is way past unreasonable. Other reasons the FDA is out of line on this guidance include the following:
There is no basis for challenging the current guidance from a safety perspective. Why are more stringent submission criteria required?
This puts the Office of Device Evaluation (ODE) in the design control review business. This is supposed to be the job of the inspectors.
There is no way the FDA can handle the additional workload this will impose. User fees could not even begin to address the mountain of submissions that would result from such a conservative guidance.
This is a long way from the “least burdensome” requirements, as defined in the Food and Drug Administration Modernization Act of 1997.
It is interesting that this guidance was followed very closely by the release of the Institute of Medicine’s (IOM) report on the 510(k) process. The major finding of this report states that the “510(k) clearance process is not intended to evaluate the safety and effectiveness of medical devices” and the “510(k) process cannot be transformed into a premarket evaluation of safety and effectiveness.” Yet this guidance is trying to make the 510(k) submission process exactly that: a stringent review of any potential safety issue.
Your thoughts are appreciated. I have already sent a lengthy letter to the FDA that included these and other reasons this guidance should be cancelled. I encourage you to do the same. If you want a copy of the letter I sent to the FDA, let me know at [email protected]. I would also appreciate your thoughts on this guidance and its ramifications.
Dan Olivier has been working with the FDA and supporting medical device manufacturers for over 20 years. He is the president and founder of Certified Compliance Solutions, providing compliance and quality system solutions to the medical device industry.
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