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Originally Published IVD Technology June 2005
INDUSTRY NEWS
OIVD premarket process gets high marks in industry survey
Matt Grebow
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| Table I. Selected statements and responses from OIVD FY 2004 Premarket Customer Perception Survey (click to enlarge). |
Ninety-two percent of applicants who received a final decision on FDA premarket review submissions last year agreed or strongly agreed that their applications were processed in a timely manner, according to a survey released by the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD; Rockville, MD). The industry poll, which was conducted by FDA’s Office of Management and Operations (OMO), asked a random sample of 102 applicants to rate their experiences with OIVD in nine categories.
For the most part, results for the second annual customer perception survey were unchanged from last year, with respondents giving OIVD positive marks in each of the areas in which they were questioned (see Table I). “Overall, it looks like most people are pleased with the premarket review process,” says Donald St. Pierre, deputy director for new device evaluation at OIVD. “The low complaint rate with respect to the ‘least burdensome’ issue was a very pleasant surprise because, although we stress this concept internally, we were not sure that the message was getting out there, and apparently it is.”
Still, St. Pierre says that there are areas for improvement. “Review consistency across divisions and not enough communication appear to be the most common concerns. Out-of-date guidances and not being able to find information on the Web site are also areas that could be improved.” When asked for suggestions to improve the premarket process, 14% of respondents cited consistency and 14% labeled communication as problematic areas. An additional 10% said guidance documents needed updating, and 8% noted frustrations with OIVD’s Web site.
To address these concerns, OIVD has focused on making a handful of internal changes. Management has begun meeting weekly to discuss cross-cutting issues, and staff members are encouraged to be more timely in responding to inquiries. Regarding guidances, St. Pierre says that during the 11¼2 years following the first survey, OIVD has issued twice as many guidances as in the two years previous. In addition, OIVD has plans to update or delete most of its older guidance. Finally, St. Pierre points to a recent overhaul of the agency’s Web site that was conducted after the latest survey was administered, but before results were issued.
The analysis branch of OMO’s division of planning, analysis, and finance, which was part of the workgroup that administered the survey, says that at this time it is uncertain whether the survey will be continued. Complete survey results can be accessed from OIVD’s Web site at www.fda.gov/cdrh/oivd/news/customerperception2004.html.
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