From the June 2007 issue of "The Silver Sheet"
If Cap Uldriks could tell device firms two things about FDA, this would probably be first: Despite the bum rap it sometimes receives, the agency isn't a secretive organization that plots to make manufacturers' lives miserable by conducting unnecessary enforcement actions and issuing confusing documents.
"A lot of people think the agency is a monolithic, kind of dark thing that you can't penetrate, and we have all this thinking that goes on in soundproof rooms, and we're strategizing like they do at the Pentagon. No," says Uldriks, a consumer safety officer in CDRH's Office of Compliance.
"Once you figure out how we think and how we work, we're really very transparent," he said during a May 16 interview in his office in Rockville, Md.
The other message Uldriks would likely send? He - like most staffers at FDA - is bogged down in work, which at times can cause delays in the release of agency documents and information. That, in turn, can lead to industry frustration.
"Recently I realized that I cannot do this all by myself. It's impossible. It's sort of like when someone is drowning and they're putting their hand up three times. I'm at three."
Uldriks points to a large stack of files in his office that measures about a foot thick and is comprised of various guidances, warning letters and citizen petitions awaiting his review. Some of the documents have been sitting there for a few months, while others have recently been added to the pile.
"Right now the things I have on my plate involve ... a condom guidance document, a gloves guidance document, two documents related to the Medical Device User Fee and Modernization Act [and] a premarket approval supplement application for manufacturing changes," he said. "Unfortunately, they're bottlenecked right here."
- Shawn M. Schmitt
More from the talk with Cap Uldriks appears in the June issue of "The Silver Sheet."
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