Medical Device Daily Washington Editor

GAITHERSBURG, Maryland — Timothy Ulatowski is the director of the Office of Compliance (OC) at FDA's Center for Devices and Radiological Health (CDRH). We sat down with Ulatowski for an interview for Medical Device Daily's sister publication, Biomedical Business & Technology, last month, and the following is excerpted from that interview.

Ulatowski said the import action plan – a response to the variety of problematic imports – is a central point of emphasis at FDA. "The agency as a whole is working on implementing the plan," he said. Devices imported from overseas plants that fall short of the agency's standards have previously faced detention, which Ulatowski said is still an option.

"The import action plan is looking at other aspects of import detention that may be applied," he said, but he noted that the threshold for detention "is dictated by statute. We have not at this point in time sought to lower the threshold in regard to that, but ... there are proposals" to that effect in the plan.

The Office of Enforcement is working with China's State Food and Drug Administration. "We have had several FDA folk, including myself, provide training to SFDA, and that will continue and be expanded," Ulatowski said, but he does not anticipate a personnel crunch.

"FDA has been, because of the efforts of our previous commissioner, provided with resources that in my experience are unprecedented," he said, noting that the inspectional staff has expanded for foreign and domestic inspections. "It will take a little time to get them trained, but the result will be much improved coverage of facilities." The additional personnel "will mean better coverage and in some cases, more enforcement action because of more inspections. FDA as a whole is ramping up and we appreciate the resources that have been provided," he commented.

Many at FDA are approaching retirement, but Ulatowski could not say whether his office would feel the crunch. "We've hired ... a spectrum of people, from people right out of college to people who have a good deal of experience as investigators, in quality systems in industry," but he could offer no specifics.

Industry has long chafed over the word "recall" because it encompasses a wide range of activities and situations. However, firms should not look for any changes to that verbiage. He noted that FDA "initiated a recall communications effort to look at how the agency deals with" such events. "Although I have not seen the final outcome of that communications initiative, we understand that there can be instances – for implantable devices particularly – where the term recall, depending on how the communication is structured, can provide some public angst."

CDRH's reticence to change the nomenclature, Ulatowski argued, is well founded. "We're concerned about making sure that industry, the healthcare community and the public are aware of important messages when they come out. So if you dilute the message by using terms that are not as striking ... I think you run into problems." The agency's point, he said, is "what you tell the doctor or patient what they're supposed to do. What is the problem? Whom do I contact if I have a question? These are all important things that in certain communications are insufficient."

Ulatowski agreed that warning letter citations for medical device reports (MDRs) are still conspicuous, but said they "wax and wane." He described MDRs as "an important aspect of regulation and one of the key signals FDA relies on to understand whether there are issues going on.

"We're trying to make things easier and trying to get in people's faces regarding MDR regulations," he noted, "I was at a conference [recently] where we talked about complaints, MDRs and drug reports quite extensively. It's an area we have to pay a lot of attention to."

Ulatowski said warning letter citations for corrective and preventive action (CAPA) have persisted over the years. He described CAPA as "a window into the company's attentiveness to doing things right," adding that a good CAPA program can "lead to goodwill and to customer support and public support for companies."

"It's something that deserves attention every day, and unfortunately in some cases these things are thrown by the wayside," Ulatowski said. He said CDRH is "not there to try and play gotcha. We're there to work with the companies to solve these problems because we're all looking out for the public's welfare and benefit." He asserted that a good CAPA program "is good for the bottom line" because it demonstrates "that you deal with and correct problems ... and are responsive to your customers."

Regarding the agency's proactive efforts, Ulatowski commented that FDA is "trying to get a profile on segments of the industry" via means that were not previously used at FDA. "We're looking not just looking at our own inspection history and information technology databases, but also at information like that provided by Dun & Bradstreet. We're utilizing economic and other information that may be an indicator of a facility or company at risk."

Several years ago, the Office of General Counsel at FDA started reviewing warning letters before publication. Ulatowski suggested he was no fan of the idea. "It's my philosophy that people checking people is not the way to run a process." He said the quality of warning letters can be guaranteed by a process, which includes ensuring "that they have a high degree of quality in regard to background supporting documentation. If those ducks are in order, then the quality of those letters and their legal sufficiency fall out on their own as adequate," he remarked.

FDA, Ulatowski said, has "put into place procedures for [warning letter] evaluations and as a result, the evaluation by the chief counsel's office has been rolled back." He stated that FDA is "on an audit program where not all the letters are evaluated. We do spot checks. We do constant evaluation of quality, and that's going to expand and be improved further."

He closed with a message for industry. "No matter how big or small your company is, it's been proven time and time again that compliance with quality systems leads directly to the bottom line. You can have a short-term or long-term view and be half-hearted about quality systems and suffer consequences for poor-quality products and problems with your company down the road," he said.

So it's "pay me now or pay me later" where quality systems are concerned, Ulatowski said, adding, "I'd rather they made an appropriate effort to maintain compliance, because it really is good for them."

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