Health Canada Response Times Surpass Own Deadlines by Days

Health Canada exceeded its review targets for device submissions during the 2015 first quarter, reviewing new Class II devices in an average of nine days, six days quicker than the 15-day goal, and completing Class IV device reviews in an average of 70 days versus a 75-day goal.

About 65 percent of all decisions were made a week or more ahead of deadline, the agency reports.

The agency received 784 new Class II applications during the period, up from 730 in the same period a year ago. The number of Class III and Class IV submissions dipped slightly—from 274 to 236 and from 94 to 86, respectively.

Fifty-nine percent of applications processed during the quarter were deemed complete on the first round. Another 29 percent required only one request for additional information, with only 12 percent needing two or more rounds of follow-up, the agency says. The most common reasons for information requests for Class III and IV devices were safety and effectiveness studies, labeling and documentation, background information and marketing history or regulatory status.

The most frequent screening deficiencies were similar: safety and effectiveness studies, background information, fees, labeling and documentation, manufacturing quality controls and licensing.

For devices other than in vitro diagnostics, marketing history and regulatory status also cropped up as common deficiencies.

Only 10 percent of applications were considered to have poor-quality data.

The Health Products and Food Branch inspectorate received more than 400 reports of adverse events in the 2014 third quarter, the last for which data is available.

About 300 of these resulted in recalls, Health Canada says. General hospital products generated the highest number of reports, with plastic surgery and anesthesiology devices also frequently implicated.

The most common observations during inspections involved establishment licensing and complaint handling, the agency says.

View the report at www.fdanews.com/05-18-15-canada.pdf. — Elizabeth Orr