Medical Device Daily Washington Editor

WASHINGTON — Have a concern, comment or complaint about the 510(k) process at the FDA's Center for Devices and Radiological Health (CDRH)? Is communication not what you expected during the device evaluation process?

Who you gonna call?

Best try the CDRH ombudsman, Les Weinstein.

Weinstein was named as the center's first ombudsman in 2000. Since that time, his role has been to work through complaints from outside the agency and to facilitate resolution of disputes between CDRH and the medical device industry. For the past five years, Weinstein has released annual reports on the numbers and types of complaints received by CDRH and what was done to resolve them.

The 2004 report, recently released, details the number of contacts received, their sources, the CDRH office involved, and reasons for the complaint.

“A wide variety of calls come from people at various stages of interaction with the Center for Devices,“ Weinstein told Medical Device Daily. “Sometimes they call because they are concerned about a decision that has come out not in their favor, and other calls are more exploratory in nature.“

Weinstein said many of the exploratory calls are done as “prep work“ by companies meeting with CDRH.

“[Calls come] from people who are coming in for a meeting and ask me to attend to get background, in case it comes to a point where they do need me,“ he explained. “It is a precaution, so I am up to speed on what the issues are should there actually be a full-blown dispute.“

Those contacting Weinstein's office are looking for impartiality and neutrality in what often can be an extremely complicated review and evaluation processes, he said.

“I look to see if I can help correct a specific complaint, mediate a dispute, or put complainants in touch with the right person in the offices,“ Weinstein added.

According to the annual report, most contact with the office takes the form of a complaint or dispute. Complaints usually involve a level of dissatisfaction, often about timeliness, lack of communication, or perhaps an unhelpful employee. Disputes involve a disagreement with or a challenge of a decision CDRH has made or will make.

In 2004, Weinstein's office received a total of 125 complaints and disputes (77 complaints, 39 disputes and nine “others“). That number was up slightly from 2003, which had a total of 120 (82 complaints and 38 disputes). Though the number of device evaluations has remained pretty consistent over the past three years, 2004 and 2003 were still well above 2002, with a total of 53 almost evenly divided complaints and disputes.

Given the fact that CDRH handles such a large volume of device evaluations — upwards of 4,000 510(k)s annually, on average, and anywhere from 50 to 100 original premarket approval applications (PMAs) a year — the number of complaints seems pretty low.

Overall, the majority of contact comes from industry — 90% in 2004. That is up from 78% in 2003, and 85% in 2002. For 2004, the next-largest source was consumers and then healthcare providers, at 7% and 3%, respectively.

Most of the concerns brought to the ombudsman's attention related to the Office of Device Evaluation — at 66% representing two-thirds of the total. The next largest was the Office of Compliance, with 22%.

An interesting statistic is that 62% of complaints were classified as coming “early in the process,“ compared to 38% that were reported by companies or individuals only as a last resort, which refers back to the “exploratory“ nature of calls that Weinstein had referred to.

The largest number of disputes and complaints last year — 28% — were about the 510(k) process. The next-largest group, both at 7%, dealt with imports and competitor/trade complaints.

The PMA process was at 6%. In 2002, by contrast, 42% of complaints were about 510(k)s and 11% concerned PMAs. Surprisingly, user fees were at 2% in 2004 and 1% in 2003.

The most common reasons for complaints and disputes in 2004 — 25% — were due to “miscommunication or lack of communication.“ The second-highest number — 16% — came from data and testing requirements to support a submission, followed by policy and procedure concerns at 14% and then a lack of timeliness (for approval, clearance, setting up meetings, returning phone calls) at 12%. Lack of timeliness was ranked second in 2003 at 18%.

“With 510(k)s, there are thousands of them,“ so complaints may result, Weinstein said, from “sheer volume,“ thus it doesn't necessarily mean that FDA regulators “are doing a terrible job processing.“

Asked to look for constant themes over the past five years, he said that miscommunication is “overwhelmingly the No.1 reason“ why people and companies contact his office.

“Even in those years when it was not the No. 1 reason, I think it really underlies most of the calls I get. There is often some sort of disconnect between [the complainant] and an office in the center and has to do with miscommunication or the lack of it — on both parts, really.“

In those cases, Weinstein says perhaps CDRH failed to explain something well, or maybe the company or individual misinterpreted what was intended. That is when sitting down with all parties involved is most helpful.

“What I do, a fair amount of the time, is set up a conference call or a meeting and act as a facilitator to try and clarify both sides, and I think I have been very successful with doing that,“ he said.

Asked about the timeliness of results improving in 2004, Weinstein said that his first reaction is that it was a direct result of user fee performance goals, but perhaps also “other factors at play.“

“When you look at my report, there are certain recurring themes, but every time somebody contacts me, it is really a different set of facts, a different set of circumstances, that I then have to decide how to approach the matter,“ he said. “That is the part of the job that is very interesting to me — the uniqueness of every situation that might require a different solution.“

At year-end, 31% of complaints and disputes had been resolved, while 35% still were pending, including all disputes for 2004 plus those that had carried over from 2003. Excluding all complaints that were withdrawn, had no follow-up by the source or were referred from outside CDRH, the percentage of resolved disputes rose to 65%.

“Sometimes companies are very satisfied with what I am able to help them with, and sometimes they are not,“ Weinstein said. “I would like to resolve all of them, but some never get resolved.“

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