More Import Delays, Inspections Expected in 2010 for Industry

Devicemakers and importers may expect delays in 2010 as the FDA trains more than 1,000 staff hired last year to conduct inspections and import screenings.

New employees probably will be trained at the borders because that’s where the highest volume of regulated commodities can be found, Benjamin England, founder of FDA Imports, told FDAnews.

The agency often stations new employees with veterans at the U.S. borders with Mexico and Canada to conduct training in FDA law, regulations and requirements, he said.

The staff increase may intensify the scrutiny of products, which in turn may cause delays. Additionally, minor technical violations may be written up because new employees will be on the lookout for any violation at first, he said, noting that “it’s going to be troublesome for the next 18 to 24 months.”

Companies also can expect increased inspections, both domestic and foreign, focusing on supplier quality, employee training procedures and corrective and preventive actions (CAPAs), Steven Niedelman, senior consultant with Crowell & Moring, told FDAnews.

But manufacturers shouldn’t be alarmed by an increase in the number of FDA investigators during inspections, Niedelman noted, adding that trainees may be sent along with seasoned employees.

The FDA will emphasize import safety as well, Reed Smith partner Fred Branding told FDAnews. “The FDA might get its act together going overseas to inspect before having products offered for import here,” he said. The agency has inspectors based in China and India. It also sends U.S.-based inspectors abroad.

In addition to training and inspections, the agency will likely continue its focus on management controls and CAPA — the “guts” of the quality system regulations — Bernie Liebler, director of technology and regulatory affairs for AdvaMed, told FDAnews.

In addition, the agency will need to pay more attention to software validation and design as software gets more complex and more devices use it, he said. — April Hollis