Renewed Industry-FDA Cooperation Set Tone in 2004

Originally Published MDDI December 2004

Medtech Snapshot

Regulatory

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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