The 2011 draft guidance governing when a change to a class II device should trigger a new regulatory filing was highly controversial, and Congress instructed the FDA to withdraw the document. However, Yarmela Pavlovic of the San Francisco office of Hogan Lovells told Medical Device Daily that the revised draft released in August is not only more nuanced, it also forces companies that previously may have been less than fully diligent about such matters to make the same effort as their more meticulous brethren.
The Center for Devices and Radiological Health penned a new "510(k) changes" draft in August, the second attempt to overhaul the K97 memo, which as its name suggests came into being in 1997. One of the controversies surrounding the 2011 attempt was that it seemed to ensure the agency would be swamped with a large volume of additional regulatory filings at a time when the FDA's resources were already strained.
Some who commented to the docket for the 2011 version suggested the K97 memo and the quality systems regulations would suffice to handle any concerns the agency had about industry's understanding of when a device could be altered without the need for a new 510(k) application. Industry lobbied Capitol Hill intensively as the discussion of the 2011 version unwound, however, and Congress responded by requiring the agency drop the document via the Food and Drug Administration Safety and Innovation Act of 2012. (See Medical Device Daily, Aug. 8, 2016.)
Pavlovic said any effect on the volume of 510(k) filings that would stem from adherence to this latest draft guidance would likely be negligible, at least from the agency's standpoint. "I do think for some manufacturers, it will increase the frequency with which they will file 510(k)s, but not nearly the extent to which" the predecessor draft would have required, she said, describing this latest iteration as "a more nuanced version of the 2011 draft," which she characterized as more of a sea change.
In the past, the FDA often seemed to take the position that more than one change to an existing 510(k) design or labeling was cause for a new filing, but there are instances in which even a single change clearly requires a new 510(k). "Some industry players weren't always doing that, so you occasionally had circumstances in which [the latest configuration of a device] looked quite different" from the existing clearance, Pavlovic observed.
Pavlovic said this new draft may go a long way toward ensuring that no one benefits from the use of regulatory short-cuts, in part because the draft is more explicit about a need to document the rationale for not filing a new 510(k) application. Once the draft is finalized, device makers will "have a better sense of whether your competitors are taking the same approach you're taking," because implementation of the documentation mandates "puts everyone on a more flat playing surface," she said.
The draft puts more emphasis on risk analysis – which seems part of a trend given the additional emphasis on risk analysis in the recently completed overhaul of ISO 13485 – and hence a device maker will have "more to work through in making your determination" as to whether the change calls for a new 510(k), Pavlovic said.
This is "probably comforting for some in industry" who already are scrupulous about such matters, Pavlovic continued, but the ever-present matter of documentation is not going away because any failure to document a decision not to file "will show up in an establishment inspection report," even if the issue does not warrant a mention in an inspectional form 483 or a warning letter. Recent FDA warning letters frequently cite companies for failure to file new 510(k) applications for changes made to a device, such as the Sept. 20 warning to Collagen Matrix Inc., of Oakland, N.J., over a change in packaging for the company's dental bone filler. (See Medical Device Daily, Oct. 12, 2016.)
Whether the new draft will hit with a thud depends, to some extent, on the company. "Some manufacturers are already filing 510(k)s" in a manner that reflects the terms of the draft, Pavlovic said, but she indicated that the Office of Device Evaluation "is pretty overworked as it is," hence the need for a less ham-fisted approach than was reflected in the 2011 effort.
Despite any trepidation manufacturers may have about this new framework for the 510(k) changes question, Pavlovic said it is a far more modest proposal than the 2011 draft, and more useful in many ways than the K97 memo. "I see it as a more measured approach" to the question than the agency came up with five years ago, she said, adding, "it does provide more meat compared to K97," thanks to the flowcharts included in the document.
The additional documentation requirements will work out well for firms, too, because the additional documentation gives a device maker "a little more to lean on if an inspector raises questions," Pavlovic said. //