The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers' procedural and documentation burdens.
The US Food and Drug Administration (FDA or the Agency) issued on August 8 a new draft guidance document, Deciding When to Submit a 510(k) for a Change to an Existing Device (Draft Guidance). Once finalized, the Draft Guidance is intended to supersede the original and currently applicable guidance with the same name, which FDA issued in 1997. Although FDA previously issued a proposed revision in 2011, stakeholders voiced significant concerns that the proposal could potentially increase the number of 510(k) submissions by 300%. As a result, Congress included a provision in the Food and Drug Administration Safety and Innovation Act (FDASIA) that required the Agency to withdraw the 2011 draft guidance and instead use the 1997 guidance.
The new Draft Guidance takes a more measured approach than the 2011 draft in evaluating changes that require a new 510(k). In general, FDA has followed the basic structure of the 1997 guidance rather than the format of the withdrawn 2011 draft guidance. Importantly, FDA has retained the flow charts for each category of change (e.g., labeling, technology/performance, and materials changes), which had been removed in the 2011 draft. Although it is difficult to predict whether the Draft Guidance will cause the number of 510(k)s filed to increase, manufacturers will likely need to bolster their 510(k) decisionmaking procedures and documentation practices.
FDA also issued a separate draft guidance document on software changes or modifications concurrently with this draft guidance.
Although the new Draft Guidance and the original 1997 guidance have many differences, we have highlighted below 10 key takeaways that manufacturers should be aware of.
Revised, Initial Guiding Principle
As the first guiding principle, FDA's revised main flowchart asks whether a change was made "with intent to significantly improve the safety or effectiveness of the device, e.g., in response to a known risk, adverse event, etc." The Agency further states that manufacturers should consider whether a change could significantly affect safety or effectiveness, "either positively or negatively" as part of conducting a risk-based assessment (see 2. below).
Use of Risk Management
The Draft Guidance includes a new emphasis on use of risk management to determine whether a change or...