PERFORMANCE STANDARDS FOR REVIEW OF CLASS III DEVICES WOULD BE ADOPTED WITHIN ONE YEAR OF ENACTMENT OF MEASURE INTRODUCED BY SEN. WELLSTONE OCT. 31
This article was originally published in The Gray Sheet
FDA would be directed to adopt performance standards to aid in the review of Class III devices within one year of enactment of an FDA device reform bill (S 1369) introduced Oct. 31 by Sen. Paul Wellstone (D-Minn.). The "Medical Technology, Public Health, and Innovation Act of 1995" calls on the agency, within 365 days of the measure's enactment, to adopt "performance standards established by nationally and internationally recognized standard-setting entities and use the standards when applicable to assist in determining the safety and effectiveness of Class III devices."
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