On October 24, FDA finalized two guidances offering insight into when a new 510(k) is required following changes made to medical devices or the software powering them.
The drafts of these two guidances were released in the fall of 2016, five years after FDA's initial attempt at replacing its 1997 guidance outlining 510(k) changes. Deciding When to Submit a 510(k) for a Change to an Existing Device (“2016 Device Change Guidance”) revised FDA's 1997 guidance of the same name. The other, Deciding When to Submit a 510(k) for a Software Change to an Existing Device (“2016 Software Device Change Guidance”), presents guidelines for particular software changes.
Regulators have stated that the final versions of the guidances have been updated for clarity and to ensure they are interpreted consistently by agency staff and device manufacturers.
A Brief History of 510(k) Submission Guidelines
Following a 2013 public workshop held by FDA in which industry and patient groups discussed new approaches to 510(k) device modifications, the Agency issued a report stating that the 1997 guidance would remain with only a handful of changes, which were presented in a 73-page guidance.
This guidance laid out the Agency's core principles for the kinds of changes requiring 510(k) modifications along with five flow charts to aid device manufacturers in determining the best course of action for particular changes.
In August 2016, FDA released a guidance to replace a withdrawn 2011 draft guidance in the wake of industry scrutiny.
We've summarized the three main clarifications made in the final versions of the guidances, particularly as they relate to scope.
No "significant" policy changes
• The Agency states that the final guidances are "not intended to implement significant policy changes to FDA's current thinking on when submission of a new 510(k) is required."
• Rather, regulators say the guidance is meant to "enhance the predictability, consistency, and transparency" of the decision-making process for when to submit a new 510(k).
Emphasizing the "least burdensome approach" to 510(k)s
• The final guidances also point out that this final guidance aligns with its "least burdensome approach" for 510(k)s, which states that FDA "shall only request information that is necessary [and] shall consider the least burdensome means of demonstrating substantial equivalence."
Routine verification and validation requirements
• FDA also states that device maker should confirm any decision not to submit a new 510(k) through successful, routine verification and validation activities. If those activities do not confirm the decision, the device maker should reconsider whether a new 510(k) is required.
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