In a move that would seem to underline its other reengineering efforts, the FDA's Center for Radiological Health (CDRH) has created, for the first time, an ombudsman position to facilitate communication and problem solving within the center. Selected for the position is Les Weinstein, formerly with the FDA's Freedom of Information office. Weinstein moved into the new post in early April but attended the annual meeting of the Health Industry Manufacturers Association (HIMA; Washington) in March to make an initial presentation and introduction to the industry and to suggest how he views his role.

Weinstein said he will be an "activist problem-solving ombudsman, advising you on the most appropriate avenues for mediating disputes and getting your questions answered." He noted that he also has been assigned the title of quality assurance manager for CDRH, calling the two roles "two sides of the same coin. As a quality assurance manager, hopefully I'll have less to do as the ombudsman."

"My immediate plans include looking at guidance on resolving scientific disputes and how to clarify some portions of it. I'll also be doing a lot of outreach – sometimes with [CDRH director] Dr. David Feigal – meeting with associations and individual representatives, getting the new dispute resolution panel fully established."

Since he is the initial person in a brand-new role at the center, Weinstein told the HIMA attendees he will be able "to set the tone – be the George Washington of ombudsmen." And he advised that when those in the industry see a problem, they should "contact me early on. There are rules, but no rules in terms of when I can get involved."

On his first day on the job at CDRH, Weinstein told The BBI Newsletter that launching the center's proposed Medical Device Dispute Resolution Panel will be one of his initial priorities. That panel, he said, is just one of several possible avenues for dealing with controversies, but he called it "the newest addition for providing a better focus to dispute resolution." The proposed panel's role will be primarily advisory, providing recommendations to Feigal, who then makes the final decision. Further appeal is then available through the FDA's ombudsman.

Asked why the CDRH has not had its own ombudsman until now, Weinstein called that "a good question. But maybe they didn't feel the need. Maybe they felt the existing procedures were adequate. But once the FDA Modernization Act was passed, that added emphasis for implementing it." Weinstein said that he and Feigal will be meeting with a broad range of industry and consumer groups to publicize the new dispute resolution panel and to emphasize the ombudsman's problem-solving role. "I want the word out that people should feel comfortable calling on me for whatever problem and issue," he said. Other than promising establishment of the panel sometime this year, Weinstein declined to promise a specific launch date. But he said that Feigal has urged him to make it "one of the first things that I do," suggesting a timeline that is sooner rather than later.

Mammography certification offered to states

The FDA has issued a new regulatory guidance document that may result in stiffer regulation of mammography in some states. In a proposed rule, the agency is providing guidance to allow mammography facilities to be inspected and certified by state government agencies. The shift to state regulation would not be mandatory but strictly optional, according to Roger Burkhart, PhD, a consumer affairs officer for the Center for Device and Radiologic Health (CDRH). Burkhart told BBI that CDRH recently completed a two-year pilot project of state certification in Illinois and Iowa, states particularly interested in assuming this regulatory responsibility. Based on the success of that project, the agency has issued the proposal to extend this authority to other states that want it.

The FDA isn't pushing the shift in responsibility to the states, but rather is taking a stance Burkhart described as "neutral," with its main goal being to establish the necessary quality and safety. "Smaller states simply don't have the personnel to do it; they may have only one or one-half position to handle it," Burkhart said. "Other states may already have longer relationships with the facilities and the program will eliminate some of the [regulatory] steps in between."

A key issue in the shift of responsibility is that the states will be able to add additional, more detailed requirements to those demanded by the FDA, he noted. The FDA's requirements provide a "quality floor," Burkhart said. "They represent the minimum, the basics to make sure that a mammography facility is operating safely." He said that up to 30 states had shown interest in the program and estimated about 20 states initially will decide to do the certification. The proposed guidance provides for a 90-day comment period. Assuming that no great changes will be required in writing the final rules, they will be put in place sometime this fall, Burkhart predicted.

FDA reclassifies devices

In another newly issued guidance – this one final – the agency in early April reclassified 28 Class III devices to Class II, a change that means the devices will now be considered under the agency's 510(k) guidelines rather than requiring the more difficult premarket approval (PMA) route. The reclassification is somewhat unusual because of the number of devices reclassified, compared to the agency's general practice of reclassifying individual devices or in groups of only two or three, according to Janet Scudiero, reclassification coordinator for the General Restorative Devices Division of CDRH. "We consider this a significant accomplishment," Scudiero told BBI, noting that the process of reclassifying a device may take up to two years to accomplish. "To do this in a big batch is unprecedented for us," she said, noting that the agency would probably be announcing similar multiple reclassifications by the end of the year or early 2001.

In approving the less-rigorous approval path, the agency is "very comfortable" with the reclassification, Scudiero said, based on the use of the 510(k) "special controls" documentation supporting each device. Special controls can range from specific FDA guidance documents to various consensus standards or "anything that can reasonably assure us of the safety and effectiveness of a device," she said.

The 10 categories and the device types reclassified include:

Hematology and pathology: erythropoietin assay, fibrin monomer paracoagulation test.

Immunology and microbiology: rubella virus serological reagents.

Cardiovascular: cardiovascular intravascular filter, external transcutaneous cardiac pacemaker (noninvasive).

Dental: OTC denture cushion or pad, OTC denture reliner, OTC denture repair kit, partially fabricated denture kit, airbrush.

Ear, nose and throat: tinnitus masker, tympanostomy tube with semipermeable membrane.

Gastroenterology-urology: electrohydraulic lithotriptor, high permeability hemodialysis system, peritoneo-venous shunt.

General and plastic surgery: esophageal prosthesis, tracheal prosthesis.

Obstetrical and gynecological: endometrial aspirator, endometrial brush, endometrial washer, endoscopic electrocautery and accessories, bipolar endoscopic coagulator-cutter and accessories.

Ophthalmic: keratoprosthesis, aqueous shunt.

Orthopedic: elbow joint metal/polymer constrained cemented prosthesis, knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis, shoulder joint metal/polymer non-constrained cemented prosthesis, shoulder joint metal/polymer semi-constrained cemented prosthesis.