The FDA may not be as nimble as industry would like when it comes to pulling the trigger on new device review, but it certainly hasn’t dawdled lately as its sets about remaking itself and its interactions with various medical device industry sectors.

Among the rapid-fire announcements recently issued by the FDA were guidelines for home health product manufacturers, new procedures for premarket approval review panels and a tougher stance with embattled infusion pump makers. On the home health front, as more complex medical products migrate to the home setting, the agency will establish guidelines for manufacturers, develop safe-use education for users and boost post-market oversight, officials said. Under its Medical Device Home Use Initiative, the FDA will zero in on negative-pressure wound therapy devices, home infusion, ventilators, and dialysis machines, among others, to ensure safe use for patients and care givers, according to Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

Yet another announcement detailed how the agency also plans to strengthen regulation of infusion pumps, a move following repeated problems and recalls of the devices. Infusion pumps deliver intravenous antibiotics, chemotherapy and anesthesia drugs. The pumps also are used at home for patients who receive regular infusions of drugs such as insulin. Shuren said many of the problems seem to be related to “deficiencies in device design and engineering” more often than user error. Shuren added that the initiative represents a “major shift” in the FDA’s device regulation. Instead of responding to each set of problems manufacturer by manufacturer, the agency wants to take an industry-wide approach. While the FDA routinely inspects company facilities, it hasn’t required that the inspections be completed before a product is approved, except for high-risk implanted devices.

The agency also has revamped the review process for its premarket approval panels. The panels, which comprise outside industry experts and physicians, provide feedback to the FDA on approval applications submitted by industry, investigated internally and then debated in an open forum. The panel meeting process has operated the same way for years. (Trust me; I’ve covered more than my fair share of panel meetings in 10 years covering the device industry.) For more details on the changes, turn to News Front on page 12.

What does all this have to do with orthopedics? Plenty.

During the recent ODT Forum in Memphis, Tenn., a number of regulatory experts advised manufacturers that we’re entering a challenging era with FDA. Not simply challenging because of a more watchful government eye, but because it’s going to be more difficult to keep up with the pace of new rules—and that the old rules no longer apply. Diana Bogard, vice president, Healthcare Economics, Government Affairs and Reimbursement for Medtronic Spinal and Biologics, told the audience that everyone in a company’s product development pipeline needs to understand what’s going on and to prepare on the front end as much as possible.

These actions are clues to how the agency is ramping up enforcement and monitoring efforts. What’s going on with infusion pumps, for example, could happen in another industry sector. With a new administration, the FDA promised a new era of enforcement—a better-organized, transparent and accountable group. They seem to be delivering on the enforcement part. Industry hasn’t seen this kind of change (is it still all about change?) in a while. This is a reminder for companies—OEMs as well as their manufacturing partners—to remain vigilant.

Christopher Delporte
Group Editor