Medical devices and outsourcing services firm Colorado MedTech is reporting progress in resolving its regulatory issues with the Food and Drug Administration. In January, the Boulder, CO-based firm received an FDA warning letter that prohibited the firm from manufacturing products subject to premarket approval application (PMA) until certain regulatory issues could be resolved.
After a re-inspection by the FDA in July, the firm said it submitted a written response to the FDA. The company has since had a number of discussions with the FDA regarding its regulatory status, and believes it had made progress in reaching resolution. The final outcome of the regulatory action and its timing are still uncertain, however, according to the vendor.
By AuntMinnie.com staff writersSeptember 17, 2001
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Colorado MedTech tagged with Q4, 2001 loss, August 21, 2001
Colorado MedTech inks supplier agreement, July 17, 2001
Colorado MedTech slips into the red in Q3, May 8, 2001
Colorado MedTech gets FDA warning letter, January 31, 2001
MedTech acquires ATL’s imaging supplies business, January 2, 2001
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