The first seven pages of the draft guidance shed light on the FDA’s motivations and goals for modifications to devices. The practical result to industry is:

  • A need for increased 510(k) submissions for existing devices
  • A slower product modification process, due to the analysis of the modification in line with the draft guidance and 510(k) review times
  • Increased personnel and resources in the regulatory departments of device companies to address the additional effort required to comply with the draft guidance

Missing Flowcharts Makes Internal Process More Cumbersome

The most obvious distinction between this draft guidance and the old guidance is the clear absence of the flowcharts, beloved by lawyers and regulatory professionals alike. The flowcharts were a useful tool used by product developers, designers, and regulatory professionals to monitor modifications to medical devices throughout the product life-cycle. In my experience, all members of a product launch team were familiar with the concepts and the basic restrictions that the flowcharts identified. The FDA has removed this tool entirely, citing fear that manufacturers were relying only on the flowcharts and not reading the accompanying text. While it is true, we have seen instances where a telescoped review of just the flowcharts got the device company into trouble, the broad consensus among industry is that the flowcharts were the most useful part of the prior guidance.

With the clarity of the flowcharts gone, device companies will need to involve legal and regulatory experts in analyzing each modification analysis. The subsequent 16 pages of dense text recount a series of questions and answers with examples. Granted, the old guidance had a similar structure, but industry reaction to the draft guidance has been clear – the draft guidance is more difficult to navigate and understand. As we work our way through the details, we are preparing our own flowcharts that will be provided to clients or utilized by our attorneys responding to client questions. Device manufacturers should consider doing the same – under the direction of the vice president or director of regulatory affairs and with legal counsel.  The ironic result of removing the flowcharts is that now there will be thousands of independently designed flow charts rather than a central and consistent communication of intent from the FDA.

FDA’s Interpretation of “Significantly Affect” Creates Front-Loaded Burden for Industry

A more subtle distinction is the FDA’s parsing of the concept of “could significantly affect” the safety and effectiveness of the device and the circumstance when the modification does significantly affect safety and effectiveness. Technically, the regulatory authority (21 C.F.R. 807.81(a)(3)) uses the term “could significantly affect.” The FDA has taken a unique approach to regulatory interpretation in the draft guidance, taking the position that “could” means all hypothetical scenarios, even if not intended or anticipated by the manufacturer. Another reading of the regulation is that “could” was used because of the timing of an analysis of a device modification. Since device modification assessments occur before the modification is commercialized, it is possible that the use of “could” in the regulation meant that the modification would, once placed on the market (“could,” for short) affect safety and effectiveness. Rather than this textual analysis, the FDA has seized upon the term “could” and interpreted it to mean that the manufacturer is incapable of determining what impacts safety and effectiveness. In place of the manufacturer’s analysis, conducted in the constrained context of the Quality System Regulation (QSR), the FDA clearly prefers that all such analysis be passed through the FDA.

This front-loading of FDA involvement in device modifications may very well be taken offensively by seasoned regulatory professionals and legal specialists. In essence, the FDA’s tone throughout this draft guidance indicates a lack of trust toward industry and a clear preference that the FDA is the appropriate and more competent entity to be evaluating device modifications. In fact, the FDA specifically states that in instances where there are “gray areas,” device companies should contact the FDA and discuss the modification with the FDA rather than conduct the assessment internally. It seems the FDA is ignoring the intense product liability landscape in which companies function and which often drives device modifications.

Perhaps the FDA missed an opportunity here to engage industry with a compromise. One option to deal with the FDA’s legitimate concerns that device companies are not seeking 510(k) clearance on major modifications would be to require industry to file amendments and modification notices to the FDA. This process could be similar to the IDE process (considered approved 30 days after it has been received by the FDA, unless the FDA otherwise informs the sponsor prior to 30 calendar days from the date of receipt) and could utilize a specific form for modification notifications. This would give the FDA an opportunity to review modifications at the highest level and also would relieve industry of the burden of filing a full 510(k) and awaiting clearance for device modifications.

Comments on the draft guidance are due October 25, 2011.