U.S., Canada to rely on common <br>medical device facility inspection data

The U.S. FDA and its Canadian counterpart, Health Canada, will start to rely on each other’s' inspectors as well as third-party inspections of medical device manufacturing facilities early next year, according to a former agency device center official, adding that other countries such as Australia may be added to this process in the future.

Lillian Gill, who recently left her position as senior associate director of FDA's Center for Devices and Radiological Health, said a common document for reviewing premarket data for 510(k) submissions -- at least between the agency and Health Canada -- may also become a reality down the road and that a new International Medical Device Regulators' Forum could help speed up harmonization efforts that have not succeed in the past.

Gill said FDA and Health Canada have agreed to the elements of a common inspection process for medical device manufacturers. This means that starting early next year, either FDA, Health Canada or a verified third party trained on the process will be able to use this agreed-upon method to inspect a medical device manufacturing facility, and FDA and Canada will accept the data, Gill said during a conference on global health. She added that Australia has also been asked to participate in the harmonized inspection process in the future.

Gill did not say if the process includes a single inspection form, which FDA officials have said could be a part of the effort, or details of the agreed upon process. Sources in the past had expressed concern over rectifying the ISO 13485 standard used by Canada and the quality systems regulation used by FDA.

The former FDA device official said she is also encouraged that harmonization efforts between the United States and Canada will extend to premarket reviews, with the U.S. and Canada being able to use Summary Technical Document format for 510(k) submissions.

This approach toward harmonization coincides with efforts by FDA Commissioner Margaret Hamburg to increase the international presence of the agency and utilize resources abroad to ensure the safety of products. A House GOP bill introduced as part of a package of FDA device reform bills would compel the agency to harmonize some regulatory requirements for devices with other countries within three years.

Gill also acknowledged the failure of the the Global Harmonization Task Force in harmonizing the medical device inspection process between the U.S., Canada, Australia, Japan and Europe. She said efforts to develop a single standard were not successful because of the differences among the systems, especially in Europe where each country maintains its own regulatory approach.

Gill said the focus of the GHTF has shifted from this approach to acceptance of each other’s systems, with regulators saying that if there are components in place to assure safety, then they will accept another country's assessment.

"It is no longer saying that you have to match one for one your requirements with mine," she said but added that there are still barriers to accomplishing harmonization by this approach.

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