Hyperthermic cancer treatment device developer BSD Medical said that it has completed the U.S. Food and Drug Administration’s pre-approval audit for the pre-market authorization (PMA) submission of its BSD-2000 hyperthermia system. In addition, the Salt Lake City-based firm reported that it has completed a routine Quality System (QS)/Good Manufacturing Practices inspection by the FDA.
BSD said that the conclusion of the on-site inspection of its facilities did not result in any written inspectional deficiencies (Form 483).
The FDA conducts a pre-approval inspection following submission of a PMA to verify that the company’s design and manufacturing processes meet the QS regulations. This process involved a five-day on-site inspection by an FDA auditor. The inspection was concluded on August 21 this year, according to BSD.