Originally Published MDDI December
2004
Medtech
Snapshot
Regulatory
Renewed Industry-FDA Cooperation Set Tone in 2004
The climate at FDA over the past year remained one of accessibility. Even with
the departure of commissioner Mark McClellan, the progress set in motion continued
under acting commissioner Lester Crawford. Crawford assured attendees at AdvaMed’s
annual conference that FDA would continue to be open to feedback from industry
as the agency brings its new programs to fruition.
“There’s a spirit of cooperation between FDA and industry—not
that industry is enthralled with everything FDA does, but there have been some
monumental changes and a real change in attitude,” Jeffrey Gren told MD&DI
earlier this year. Gren is director of the Office of Health and Consumer Goods,
International Trade Administration, for the Department of Commerce.
The statistics on the following pages reflect data from the CDRH 2003 annual
report. Of particular note, third-party organizations reviewed 190 510(k)s,
a 50% increase over the previous year (see the graphs on page 62). ODE attributes
the increase in part to the implementation of MDUFMA user-fee provisions that
require applicants to pay a fee when submitting 510(k)s directly to FDA without
a third-party review.
This was the first year that MDUFMA was in full swing. During 2004, the Office
of Device Evaluation (ODE) hired more than 70 employees across a range of disciplines.
ODE also made great strides toward standardizing the review process of IVDs,
said Steve Gutman, MD, director of the Office of In Vitro Diagnostic Device
Evaluation and Safety.
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