New FDA Guidance Not Popular Among Industry Players

Boston Scientific Corporation, a medical device company based in Natick, Mass., has informed the U.S. Food and Drug Administration (FDA) that it would like to see major changes to the FDA’s draft guidance that tries to clarify for industry when a potential change to a device is a recall and to distinguish those instances from product enhancements.

Boston Scientific wrote to the FDA before the May 23 deadline, saying that while the guidance issue was appreciated, it fell short in several ways.

“Having a framework that the agency and industry can leverage to distinguish between recalls and enhancements will help ensure timely recalls when a recall is necessary, and avoid confusion or disagreement when one is not,” Boston Scientific told the FDA. However, the company said it was worried “that the draft guidance document has not achieved its purpose in clarifying the difference between product enhancements and recalls. We believe that there are some underlying inconsistencies and oddities in existing regulatory language that may be driving the difficulty in explaining and/or understanding the difference between enhancements and recalls.”

The draft guidance, issued on Feb. 22, attempts to better distinguish between the need for a device recall and a device enhancement. Only changes to devices to remedy a legal violation qualify as a recall, FDA said. Changes to devices that do not qualify as a legal violation are considered to be product enhancements and not recalls.

In its comments, Boston Scientific said the FDA needs to better define the terms “correction” and “removal.” The company said the language did not agree with the current statute.

According to the company, the definitions of correction and removal should not include “product enhancement.” According to Boston Scientific, “any change to a definition that appears in the Code of Federal Regulations … should be modified through appropriate notice of rulemaking and comments to update the definition in the regulation.” FDA did not do this, the company said, and as such made improper use of a guidance document.

The company said that the definitions used in the guidance were inconsistent with one another. “We believe that FDA’s introduction of ‘product enhancement’ in the definitions of ‘correction’ and ‘removal’ introduces conflicting definitions within the guidance document, and should be avoided,” Boston Scientific said.

In addition, the company said that “correction” and “removal” most often are used in a recall situation, and now have a negative connotation. “We believe that distinguishing between ‘correction’ and ‘product enhancement’ and eliminating any overlap between them will help reinforce the understanding that modifications undertaken to correct violative products are recalls, whereas product modifications undertaken as part of a firm’s continuous improvement and sustaining engineering efforts are ‘product enhancements,’ and not a recall.”

The Advanced Medical Technology Association (AdvaMed), a medical device industry advocacy organization, said in its May 23 comments that the agency should completely pull the draft guidance and release a revised draft. AdvaMed said the draft proposes “fundamental changes in FDA policy as it relates to recalls, corrections and removals, and product enhancements. While this draft guidance addresses important policy issues, we believe significant aspects of the draft guidance are at odds with existing FDA regulation and policy, and that it is necessary to resolve these discrepancies prior to issuing guidance or regulation in this area.”

Specific areas of concern according to AdvaMed are misinterpretation of 21 CFR Part 806, proposed changes to Part 806 that will not promote public health, and lack of an appropriate approach to the distinction between enhancements and recalls of “violative” products. AdvaMed said Section VI of the draft would require that all product enhancements be evaluated for reportability under Part 806. “This would appear to include changes made for future unreleased products or models. Yet this ignores the fact that both the [food and drug law and FDA’s regulations] define recalls, and require reporting only for actions affecting products in the field at their ‘point of use.’”

The trade group said FDA “cannot, and should not, attempt to create a new notification system for design changes in products that involves ad hoc evaluation by the Office of Compliance or by the FDA District Offices under Part 806.” That responsibility, AdvaMed said, lies with the Office of Device Evaluation at FDA.

The draft guidance, FDA said, “will discourage innovation by adding another layer of device evaluation review by other agency offices outside of [the Office of Device Evaluation], diverting agency and industry resources into creating substantial, unnecessary paperwork for many changes that did not previously require reporting, slowing down the process by which positive changes can be implemented, and increasing the costs of those changes.”

Merck Research Laboratories, the research arm of Whitehouse Station, N.J.-based pharmaceutical manufacturer Merck & Co., told FDA that the draft guidance should clarify whether the scope covers combination products. If it does, the company suggested, FDA should clarify which specific products the guidance covers.

Merck also said it needed further clarification from FDA regarding whether transportation, distribution, or supply chain changes would constitute a product enhancement or a recall.

In terms of scope, Boston Scientific said the FDA should narrow its focus and be more specific. “In the guidance document, the starting point for the analysis to distinguish a recall from a product enhancement is whether a manufacturer is considering making a change to its device. We believe that this starting point is too broad, and appears to be inconsistent with the regulations at 21 CFR § 7,” which define a recall as removal of a product that was in violation of the laws.

When any minor changes are made to a device “absent any violations or risk to health, the manufacturer should not be required to evaluate these changes for a determination of enhancement vs. recall. To do so would be overly burdensome, resource intensive, and would introduce significant delays in a manufacturers’ routine operations,” Boston Scientific wrote.