Medical devices: FDA can improve oversight of tracking and recall systems : report to the Subcommittee on Oversight and Investigations, Committee on Commerce, House of Representatives
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54 recalls 90 workdays adverse health consequences agency artificial heart valve August 29 breast prosthesis calendar days class II recalls complete recalls corrected or removed defective devices defibrillators device manufacturers device tracking regulation device tracking systems devices and patients distributors district offices end users failed establishments FDA Inspections fda issued FDA's Medical Device fda's recall fdama Federal Food fiscal years 1994 gmp inspections heart valves high-risk devices implement initiated January 16 manufacturer's manufacturers and fda manufacturers subject manufacturers to complete medical device tracking number of calendar number of devices number of workdays Office of Compliance Office of Regulatory pacemaker percent prosthesis provide fda public health recall completed recall records Recalls of Medical recalls of tracked Regulatory Affairs require fda require manufacturers SMDA 90 subject to tracking terminate recalls terminate the recall terminated by fda Total recall tracked devices tracking obligations tracking records tracking requirements Vitek