The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document that could potentially require medical device manufacturers to report a wide variety of device improvements, ranging from routine updates to those with an immediate impact on patient safety. In particular, any “product enhancement” intended to reduce health risks must be reported, and all written correspondence discussing the change must be provided to the FDA. Thus, if the guidance is finalized, manufacturers may be obligated to report any prospective, perfunctory product modifications that could conceivably have some impact on patient health, in addition to major changes with obvious safety implications.
The FDA’s articulation of what is essentially a new duty of medical device manufacturers might seem like a new regulation, and thus subject to the rulemaking process. However, the FDA characterized the duty to report product enhancements as a distinct subcomponent of the duty to institute a full-fledged product recall. As such, the new standard is ostensibly a clarification of the FDA’s interpretation of existing regulations, not a new regulation itself, and thus appropriate for a guidance document.
The industry’s primary concern is the draft guidance’s potential impact on product liability, because every improvement affecting safety allows the implication that the existing product on the market is unsafe to some degree. It also portends, however, a dramatic increase in regulatory compliance efforts, because the vast number of device modifications occurring per year would have to be reviewed for potential health impacts. And, of course, it impacts regulatory responsiveness because the safety implications of each of those modifications must be reviewed by the FDA, an agency already heavily taxed by, among other things, its oversight of hundreds of pharmaceutical and medical products each year – including more than 1,200 medical device recalls last year alone.