d that manufacturers would become accustomed to these reports.

Regarding the expectation that assurance case studies will pull down the volume of adverse events associated with infusion pumps, Neder-Flack said, "theoretically it makes a lot of sense," but acknowledged there is some uncertainty. "That has yet to be played out. I don't know how many manufacturers have actually submitted safety assurance cases," she said, indicating she is unaware of any reports indicating that devices that have gone through this process are associated with a lower rate of adverse events.

Regarding the notion that assurance cases are redundant for the quality systems regulations, Neder-Flack commented, "the quality systems regulation is appropriate, but it's at a very high level," adding that FDA seemed to be of the view that a QSR approach alone was insufficient because of what the agency believes is an unacceptable rate of adverse events.

"I think this guidance, because it is so thorough," will reduce the number of headaches and recalls manufacturers experience with infusion pumps, Neder-Flack observed, remarking further that much of the guidance "goes to the field of human factors engineering." She said nurses have to be trained on "at least 23 very complex products that can be used on any patient in the ICU at any time," and consequently, "the product has to be made as intuitive as possible."

Neder-Flack declined to predict whether a case assurance report requirement will find its way into other product categories, but she stated, "at the recent FDA/AAMI ventilator summit ... the issue of safety assurance cases for ventilators came up." However, she said she is not sure whether FDA has decided to add this requirement for ventilators.

Among the comments filed for the draft was a July 23, 2010, letter from Mark Leahey, president/CEO of the Medical Device Manufacturers Association (MDMA; Washington), who said FDA officials had publicly acknowledged a day after the draft emerged that the agency was "treating the draft guidance as immediately effective," hence undercutting the comment period.

Leahey asserted that pre-clearance inspections are unnecessary and presume a need for an inspection despite a lack of evidence to support the idea. He pointed out that FDA has the authority to inspect any device manufacturing plant "for any reason at any time," adding that routine pre-clearance inspections "would result in a logjam" of inspections, a condition Leahey said device makers had argued was already an issue in connection with pre-approval inspections. Leahey added that the draft "include[d] a troubling presumption by FDA" that most device changes would trigger a need for a new 510(k), which he described as "an overly broad generalization that should not be included in the guidance document.

The May 14, 2013 comment by the Advanced Medical Technology Association (AdvaMed; Washington) addressed the agency's information collection announcement for the draft, arguing that the assurance case mandate "goes beyond the statutory requirement to demonstrate substantial equivalence," and that hence any such requirement "must be imposed via a change to the regulations (i.e., a special control)."

AdvaMed also argued that development of assurance reports would consume a dozen "man months" whereas FDA had estimated 112 hours. The association's VP for technology and regulatory affairs, Tara Federici, also noted that AdvaMed had drawn up an infusion pump assurance case template, but that even with this kind of least burdensome approach, manufacturers would still need man-months to complete such a study.

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