When medical devices undergo changes, it leaves sponsors asking a critical question: Does the change require a new 510(k) submission?
Before trying to answer that question, it’s important to remember that the goal of assessing a new change is not to determine whether the new version of the device is substantially equivalent (SE) to the old one.
Instead, you have look deeper into SE to get at its most basic component: determining whether or not the newly changed version “raise[s] different questions of safety and effectiveness than the predicate device.”
If it does, a new 510(k) will be required. Once submitted, FDA will determine whether the newly changed version of the device is still substantially equivalent to a legally marketed existing device.
Why this Distinction is Important
The difference between these two concepts may seem trivial, but deciding if a change raises new questions of safety and efficacy is different than asking than whether or not it is significantly equivalent to an existing device.
While FDA may determine the modified device to be SE to another, questions around safety and efficacy could still exist.
Clarifying Confusing Terminology When Choosing a 510(k)
The New 510(k) Paradigm refers to “Special 510(k): Device Modification,” however, the use of the term “Special 510(k)” is purely coincidental in reference to the three overarching types of 510(k)s: Traditional, Special and Abbreviated.
In reality, any of these kinds of 510(k)s can be used after making device modifications depending on the relevant factors with each category.
In the case of a Special 510(k), for example, the submission depends on a declaration of conformity with design controls. However, design control compliance may or may not be present, so a sponsor may opt for an Abbreviated 510(k), which instead, hinges on a declaration of conformity to recognized consensus standards.
If there is insufficient conformity to these standards, a sponsor could use a Traditional 510(k). This way, real data in support of SE is provided for FDA to review. While these factors can play a big part in the 510(k) decision-making process, they represent just one area of consideration in addition to the other strategic and operational factors that could affect your decision.
What to Expect in the Future
Speaking at the Regulatory Affairs Professionals Society (RAPS) Regulatory Convergence conference last year (2015), CDRH’s Michael Ryan clued manufacturers into what an upcoming draft guidance might include regarding 510(k) submission decisions.
1. Better flowcharts
Ryan acknowledged the usefulness of flowcharts included in the 1997 guidance document which have been used for years as tools for decision-making, but noted that these will be updated to more closely align with the content of the draft guidance.
2. New rules around material changes
Describing it as "one of the most difficult issues we have in deciding whether a 510(k) is necessary," Ryan added that a new draft guidance will address how changes materials will impact biocompatibility and device performance.
3. Clarity around key terms
Lastly, Ryan suggested FDA will clarify important terms such as “could significantly affect” and “major” changes in intended use, two of the key areas affecting the decision around 510(k) submission.
If you’re dealing with regulatory issues related to your medical device, our staff of former FDA and industry experts can help. Contact us today to start a conversation.
Photo: Quinn Dombrowski