Craig Rotzoll, Regulatory Project Director
New Eligibility Criteria for Technological Changes
Under the existing FDA guidance2, the following well-defined device modification types were identified as being appropriate for review in a Special 510(k):
– Energy type
– Environmental specifications
– Performance specifications
– Ergonomics of the patient-user interface
– Dimensional specifications
– Software or firmware
– Packaging or expiration dating
The above prescriptive list is being replaced under the new draft guidance by allowing that if testing is needed to evaluate the change, then eligibility is to be based on two new criteria, potentially expanding the types the technological changes eligible as Special 510(k)s. The first new criterium is the manufacturer’s ability to justify and use well-established methods to evaluate the change; the second is whether the results can be sufficiently reviewed in a summary or risk analysis format.
The draft guidance defines well-established methods to include:
– The submitter’s methods, protocols, and acceptance criteria used to support the previously cleared 510(k) that can be applied to the subject Special 510(k); or
– Methods found in an FDA-recognized voluntary consensus standard; or
– Widely available and accepted methods published in the public domain, scientific literature, or found acceptable by FDA through a 510(k)-clearance, a granted De Novo classification request, or premarket application (PMA) approval.
Therefore, the change cannot be reviewed as a Special 510(k) in the absence of a widely available and accepted method published in the public domain or recognized or accepted by FDA.
On the other hand, a change should be eligible for review as a Special 510(k) when the change has been evaluated using the same unmodified protocol, methods, and acceptance criteria as described in the predicate’s cleared 510(k) and the results for each test can be summarized without the use of images, raw graphics, or line item data requiring interpretation by FDA.
It should be noted that significant protocol or acceptance criteria deviations to a well-established method may negate eligibility for the Special 510(k) program. Non-significant protocol changes should be discussed in the results summary describing why the test methods, acceptance criteria, and results support substantial equivalence.
Assessment for Special 510(k) Eligibility
In light of the new eligibility criteria, FDA includes example assessments within an appendix of the draft guidance illustrating a thought process guided by the following four questions:
1. Is it a change to the manufacturer’s own device?
2. Is testing needed to evaluate the change?
3. Is there a well-established method to evaluate the change?
4. Can the data be reviewed in a summary or risk analysis format?
A “NO” response to any of the questions in bold listed above indicates the modification cannot be reviewed as a Special 510(k).
Special 510(k)s in Summary
Though the updates may appear to be subtle, they have the potential to expand the types of technological changes eligible for review as a Special 510(k), while at the same time potentially narrowing eligibility due to the new limitations regarding the use of well-established methods and concise summaries.
These changes to the guidance are nonetheless important to understand for overall submission success. Ensure you know the differences between intended use and indications for use as well as understanding context of the test methodologies you may be using when considering the Special 510(k) pathway.
RCRI consultants are available to help you develop your regulatory strategy. To be put in touch with an RCRI expert, contact Samantha Spence at firstname.lastname@example.org or 952-224-2260.