Regulatory Actions
BSD Medical Announces Conclusion of FDA Pre-approval Audit for BSD-2000 PMA Submission
Published in Lab Law Weekly, September 7th, 2007
BSD Medical Corp. (AMEX: BSM) announced the completion of the Food and Drug Administration's (FDA) pre-approval audit for the PMA submission of the company's BSD-2000 hyperthermia system, along with the completion of a routine Quality System (QA)/Good Manufacturing Practices (GMP) inspection. FDA did not provide any written inspectional deficiencies (Form 483) at the conclusion of the on-site inspection. The completion of the preapproval FDA inspection is a significant milestone in the PMA approval process for a medical device. The FDA's review of the company's PMA submission is ongoing.
FDA conducts a pre-approval inspection following submission of a PMA to verify that...
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Source: Lab Law Weekly (2007-09-07)
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