By Jim Spencer Star Tribune – May 2, 2017
WASHINGTON – A high-ranking Medtronic official appeared on Capitol Hill on Tuesday to ask Congress to make changes in the way government regulators inspect device manufacturing facilities for flaws.
Pat Shrader, Medtronic’s vice president for global affairs, told a House subcommittee that inspections come with too little warning and are too “erratic” for companies to supply information, clarification and follow-up that might keep them from being sanctioned.
“Device facilities in the U.S. are often given very short advance notice of an inspection,” Shrader told the House Energy and Commerce Health Subcommittee. “This short notice, plus the often erratic schedules of investigators, leads to challenges in assembling the appropriate team members to provide the required documents and materials requested by the FDA.”
Shrader spoke not just for Minnesota-run Medtronic, but on behalf of the Advanced Medical Technology Association, the device industry’s main trade group, which includes other major Minnesota employers, such as 3M, St. Jude Medical (through its new owner, Abbott Laboratories) and Boston Scientific.