FDA PROGRAM TO ADDRESS MULTIPLE INSPECTION REQUIREMENTS MAY NOT WORK FOR ALL FIRMS
An FDA program that encourages eligible device firms to pay accredited organizations to conduct their inspections rather than having the FDA conduct inspections for free may work better for larger firms than smaller ones, according to a new report.
In response to the rapid expansion of the medical device industry and the inability of the FDA to conduct inspections every two years as required, the Medical Device User Fee and Modernization Act passed by Congress in 2002 included provisions to allow certain firms the option of paying for inspections, according to the Government Accountability Office (GAO) report.
"Five or six years sometimes pass between FDA inspections at any one establishment," according to Sens. Edward Kennedy (D-Mass.) and Mike Enzi (R-Wyo.) and Reps. John Dingell (D-Mich.) and Joe Barton (R-Texas), who requested the report.
The GAO interviewed four accredited organizations, three trade associations and six device firms. The accredited bodies said they would probably charge manufacturers "from $1,700 to $2,500 per day, plus the cost of travel and living expenses," to conduct inspections, the report said.