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Capitol Hill In Brief

This article was originally published in The Gray Sheet

Executive Summary

Import safety bill: A new draft of the drug portion of the proposed FDA Globalization Act crafted by the House Energy and Commerce Committee and posted on the panel's website July 28 indicates that Congress is continuing its work on the measure, but in separate pieces. The only language pertaining to devices in the draft is the requirement that each drug and device establishment have a unique identification number. However, the House panel is still interested in addressing imported medical device safety, and will most likely take up that section of the bill after the congressional recess ends on Sept. 8, a house staffer said. At a hearing on the act in May, Republican members of the committee's Health Subcommittee, including Rep. Joe Barton of Texas, supported an industry position on the bill that the device components of it should be removed and dealt with separately. Barton opposed requirements in the legislation calling for pre-market inspections of all class II 510(k) devices ("1The Gray Sheet" May 19, 2008, p. 4)
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