This recently issued guidance (http://bit.ly/Substantial-Equiv-Guidance) for evaluating Substantial Equivalence (SE) is well written and informative, with well-chosen and written examples. For newbies to 510ks, this is the place to start. The guidance includes background information about the 510k process and links to other documents. If you are an experienced professional, this is a must-read insight into the FDA’s current approach. Use it to guide your strategy for your next submission, and make it as easy as possible for the reviewer to reach a decision of SE for your device.
Change #1: 510k Flowchart
The 1986 flowchart guiding the decision of SE was updated and re-formatted to improve clarity. A substantial part of the guidance explains the thinking process that guides a reviewer at each decision step. If you are in the middle of preparing a submission, as I am, then the guidance provides an opportunity to review your work against current FDA thinking and training and adjust your submission to align with the FDA.
Change #2: Predicate Selection
Much has already been written about how this document may alter your selection of a predicate device. The FDA clarifies that split predicates (one for intended use equivalence, another for technological equivalence) have been ruled out. The FDA also recently released another guidance document to assist with performing a benefit/risk analysis (http://bit.ly/SE-Benefit-RIsk) when you are developing a device with a different technology than the predicate. The checklist below is intended to help you review your submission when you have already chosen an appropriate predicate.
- If you are using multiple predicates, have you stated which one is your primary predicate, the one that is most similar to your device? The FDA must find your device substantially equivalent to one other device.
- Are you using secondary predicates only when you are combining features, have more than one intended use, or have additional indications for use?
- Is the intended use the same as that for the predicates? Carefully compare your Intended use and the Indications for use with those of the predicates. If they are worded differently, have you explained how they are nevertheless the same?
- Have you provided a rationale for your choice of predicates in a way that aligns with the guidance?
- Is your SE table organized such that the secondary predicates only support the additional indications for use?
- Has your predicate been involved in a design-related recall?
- Double-check the Indications for Use statement in your labeling. Regulations state that the determination of the same intended use must be made against the labeling, not against what you say in the submission. Of course, what is in the submission should match the labeling.
- Have you included a copy of the labeling for the predicate device, e.g., the user manual?
- Does your Description section have sufficient information about the technical characteristics? The FDA is quite specific about what they want to see. Check your Description against the lists on page 19, and at (http://bit.ly/510k-Content) and in any device-specific guidance.
- Does your SE table identify similarities and differences in technological characteristics in a structured way?
- Do you make it clear why each of the differences does not pose a significant safety or effectiveness concern?
- Clinical performance data. Do the examples in the guidance suggest that you might need clinical evidence after all?
- If you are using an animal study, does it comply with applicable parts of GLP regulation (http://bit.ly/21-CFR-58)? This was already flagged in the RTA checklist (http://bit.ly/FDA-RTA-Policy). If the RTA reviewer can’t tick those boxes for question 39, then your submission won’t make it through the review.
Change #3: 510k Summary Template
Eleven pages, a quarter of the guidance document, are devoted to the 510k Summary, which will be posted on the FDA website. The guidance states that “FDA intends to verify the accuracy and completeness of the information included in a 510(k) Summary.” Your reviewer will have been so instructed. There is no change to the regulatory requirements for the Summary, but anyone who has combed through these while searching for a predicate will know that many Statements are incomplete.
The FDA states that their focus on the Summary is in the interests of transparency, and they are making their point quite clearly in this guidance. As well as explaining each requirement, an example is provided. Therefore, I will be using Appendix C as a template for my 510k Summary.