|Footnotes for this article are available at the end of this page.
The Food and Drug Administration recently issued a Warning Letter to a medical device manufacturer for making significant changes to its 510(k)-cleared products for uses outside the scope of the 510(k) clearance, among other reasons.1 While the Warning Letter focused more on quality-related issues, it is a reminder that the agency continues to monitor products that might require a new 510(k) and will take enforcement action as needed.
- The company held a 510(k) clearance for the medical device.
- FDA became aware of the unlawful promotion during a quality-related inspection.
- However, over time, the firm made many significant changes and modifications in design, components, method of manufacture, and intended use.
- FDA said that the changes were outside those reviewed in the cleared 510(k): “These and other changes could significantly affect the safety or effectiveness of the device within the meaning of 21 CFR 807.81(a)(3).” Therefore, the company should have submitted a new 510(k), but did not.
- FDA found the product to be misbranded for failure to submit a new 510(k) premarket notification. The agency also said that the promotion of the device for the unapproved use adulterated the device, because it did not have an approved Premarket Approval Application or Investigational Device Exemption.
- Further, the company did not validate the changes to ensure that the device still met its intended use. The company also failed to conduct testing under an approved protocol to confirm the safety of the device following the applied changes.
- To quote from the Billy Joel 1977 song, “Just The Way You Are,” “don’t go changing” a medical device without a 510(k) (or a new 510(k)) without carefully reviewing whether the change significantly affects product safety, efficacy, or is a major change or modification of the intended use. If such a change occurs, the company must tell FDA through a new submission.
- It seems FDA became aware of the issue through an inspection, not due to some active promotional activity (the Warning Letter does not suggest otherwise.) Therefore, companies should be cognizant that the agency can learn of the lack of a 510(k) from many sources.
- FDA noted a number of changes to the product that could affect safety, efficacy, or intended use, which led to the agency’s concern and observations. We have many clients that make many “minor changes” (their words) and document for the internal file why a new 510(k) is not needed. However, many little changes can turn into big changes; it all adds up.
- If changes are made, ensure that they are properly validated and tested for safety concerns under an approved protocol.
- FDA will not take you just the way you are — if you go changing.
 The Warning Letter is available here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cardioquip-llc-621738-02112022.