COURT THROWS OUT FDA SUIT AGAINST UTAH MEDICAL
A federal district court recently dismissed a key case that could have changed what device manufacturers must do to meet the agency's good manufacturing practice requirements.
In an Oct. 21 memorandum, Judge Bruce Jenkins of the U.S. District Court for the District of Utah threw out the government's claim that Utah Medical Products (UTMD) violated the FDA's Quality System Regulation (QS).
In dismissing the case, the court said UTMD had met the QS requirements, even if it had not done so in a manner that the FDA found satisfactory. QS governs the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation and servicing of all finished devices intended for human use.
The court has been impressed by Utah Medical's design of product, its record-keeping of each step along the way, the acceptance in the market of its products, the company's uniform processing of complaints, and the manner in which change is made in practice and procedure as a result of complaint handling, according to Jenkins' memorandum. "It makes no sense for the court to order Utah Medical to do something they are already doing," he writes.
The FDA, which filed the lawsuit in August 2004, had argued that certain industry standards dictated the steps UTMD must take to comply with the QS. The FDA specifically alleged the company failed to validate certain manufacturing processes and computer software, maintain adequate corrective and preventive action procedures, and ensure the timely handling of complaints.
UTMD challenged that claim, responding that the QS does not include requirements for industry standards. The FDA has never issued any regulations detailing what these standards include, the firm said.
The case, if it had been allowed to proceed, would have set a precedent for what is expected of companies under QS, since this is the first dispute interpreting the regulation to make it to trial, according to attorney Larry Pilot, who represents UTMD. The company manufactures devices for obstetrics procedures as well as for the neonatal, gynecology, urology and electrosurgery markets.