FDA Issues Guidance Clarifying When Changes or Modifications to an Existing 510(k) Require New PMA Submission

Jul 28, 2011   

On July 26, 2011, the U.S. Food and Drug Administration (FDA) issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device necessitate a new premarket submission. In order to introduce a medical device into the interstate market, the FDA must either approve a premarket application (PMA) or clear a 510(k) premarket notification. Lower-risk devices are often submitted through the 510(k) premarket notification process, whereby the FDA “clears” the device for sale if it is found to be substantially equivalent to a previously cleared predicate device. The FDA announced that an additional 510(k) notification is required in instances where a change or modification to a cleared device would “significantly affect the products safety or effectiveness” or “constitute a major change to the intended use of the device.”

The new draft guidance outlines when an additional 510(k) notification is required for compliance with FDA regulations. The guidance suggests that manufacturers should compare the modified device to the most recently cleared version of the device to determine whether the modification could significantly affect its safety or effectiveness. In addition, manufacturers should assess individual changes to a device to determine whether, if at all, any of those changes constitutes a major change to the products safety, effectiveness, or intended use. A manufacturer should clearly document whether it believes the change does or does not require submission of an additional 510(k) notification, as well as the reason for that decision.

Furthermore, the FDA provides specific guidance to help manufacturers determine whether to submit an additional 510(k) notification for changes or modifications to the manufacturing process, product labeling, technology or engineering, or material type. This guidance also instructs manufacturers to weigh whether bench testing or simulations are sufficient to assess the safety or effectiveness of a modified device. Absent clear evidence of safety or effectiveness from these types of testing, the FDA suggests that manufacturers conduct clinical data using human subjects to validate the safety of these products.

This guidance document is part of the FDAs Plan of Action for Implementation of 510(k) and Science Recommendations, a series of action items launched earlier this year intended to “enhance predictability, consistency, and transparency of the FDAs premarket review programs.” For more information about the FDAs Plan of Action, see our previous post here.

Fuerst Ittleman is well-equipped to assist members of FDA-regulated industry navigate the laws and regulations applicable to medical devices. For more information about the current regulatory framework surrounding medical devices, please contact us at contact@fidjlaw.com.