A Medical Device Daily

Physio-Control (Redmond, Washington), its parent company, Medtronic (Minneapolis), and their two top executives have signed a consent decree of permanent injunction with the FDA related to automated external defibrillators (AEDs) manufactured by Physio-Control.

The consent decree prohibits the manufacture, distribution and export of specified AEDs at or from Physio-Control's facility in Redmond until the devices and facilities have been shown to be in compliance with the FDA's current Good Manufacturing Practice (cGMP) requirements, as set forth in the Quality System regulation for devices.

The news will most likely put the continued kibosh on the previously disclosed planned spin-off of Physio-Control, which Medtronic had reported at the end of 2006 (Medical Device Daily, Dec. 5, 2006).

The FDA said inspections conducted in October 2006 and January of this year revealed cGMP deficiencies, including failure to establish and maintain adequate procedures for validating the device design and failure to establish and maintain adequate procedures for implementing corrective and preventive actions.

While the agency noted that these deficiencies do not necessarily mean that the defibrillators currently on the market will harm patients, it is requiring corrections to ensure "the continued availability of safe, effective, and reliable products."

Previous FDA inspections in 2000, 2003 and 2005 showed similar violations, the agency said. FDA issued warning letters after the 2000 and 2005 inspections, citing the cGMP violations.

The AEDs subject to the decree include Lifepak 12, Lifepak 20, Lifepak 500, Lifepak 1000, Lifepak CR Plus, Lifepak Express, and their components and accessories, including the Lifenet Systems.

Under terms of the decree, the companies agreed to take necessary measures to ensure that AEDs manufactured and designed at the Redmond facility comply with cGMP requirements and FDA regulations for reporting device corrections and removals.

Manufacturing and distribution may resume once the FDA is satisfied that the facility is in compliance with the law. To ensure compliance, an outside expert will conduct yearly audit inspections for five years, submitting findings to the agency.

The decree also provides that the companies are subject to liquidated damages in the amount of $15,000 per day if they fail to comply with any of the provisions of the decree, and an additional sum of $15,000 for each violation of the consent decree, the Federal Food, Drug, and Cosmetic Act, or FDA regulations.

The decree, filed on April 25 in the U.S. District Court for the Western District of Washington, is subject to court approval.

SEC to raise securities registration fees

The Securities and Exchange Commission reported that it plans to raise the fees that public companies and other issuers pay to register their securities in FY09.

The new fees will be set at $55.80 per $1 million. In addition, the fees applicable to most securities transactions will be fixed at $9.30 per $1 million.

As required by the Investor and Capital Markets Fee Relief Act, the SEC said it consulted with both the Congressional Budget Office and the Office of Management and Budget regarding the annual adjustment, which will not affect the amount of funding available to the SEC.

A copy of the SEC's order, including the calculation methodology, is available at http://www.sec.gov.