On February 26, 2014, the Food and Drug Administration (“FDA”) submitted a “Report on FDA’s Policy to be Proposed Regarding Premarket Notification Requirements for Modifications to Legally Marketed Devices” to Congress, which concluded that the existing guidance under Section 510(k) of the Food, Drug and Cosmetic Act (“FD&C”) is a solid foundation and should remain mostly unchanged.
Current guidance was issued in 1997, titled “Deciding When to Submit a 510(k) for a Change to an Existing Device,” and requires manufacturers to notify the FDA of changes to existing devices that may lead to “significant” or “major” safety or effectiveness issues. As a result of the most recent analysis, FDA plans to make the following targeted changes while leaving the overarching policy framework intact:
- Clarify key terms from FDA’s regulations and explain how quality system processes may be used in deciding whether to submit a 510(k);
- Add an updated flowchart and additional appendices, including an appendix containing examples of device changes that do and do not require 510(k) submissions, and an appendix containing guidance on how companies should document their decision-making process and rationale regarding 510(k) device modification submission decisions;
- Develop device-specific recommendations for types of changes that may require a new 510(k) and include those recommendations in device-specific guidances, as appropriate;
- Develop a separate guidance on 510(k) submissions for changes to device software.
The FDA aims to strike a balance that will “leverage existing quality system requirements to reduce premarket burden, facilitate continual device improvement, and provide reasonable assurance of the safety and effectiveness of modified 510(k) devices.”
The Secretary of Health and Human Services was required to submit this Report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate under section 510(n)(2) of the FD&C Act that was added to the FD&C Act by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012.
