FDA readies overhaul of inspection program

The FDA is reportedly set to revamp its inspection program in a few months, according to Dr. Jeffrey Shuren, the director of the safety watchdog’s Center for Devices & Radiological Health.

Testifying before the House Energy & Commerce Committee yesterday, Shuren said the CDRH’s Office of Regulatory Affairs aims to improve its efficiency in conducting inspections of facilities where medical devices and drugs are made.

“As a part of the program alignment effort – which is getting officially stood up in the coming weeks – [ORA] is looking to revisit their standard operating procedures and other processes to make device inspections more efficient, more timely and to have the right kind of engagement back with the companies,” Shuren said, according to Regulatory Focus.

FDA spokeswoman Lyndsay Meyer told the website that the changes at ORA are slated to begin May 15, with the office moving from a regional structure to a “commodity-based” structure with divisions for medical devices, drugs, biologics, bioresearch monitoring, food and tobacco.

Shuren, speaking at a hearing on the Medical Device User Fee Amendments, was asked why foreign inspections are more streamlined than domestic investigations.

“It is true that domestic inspections may take longer than foreign inspections. For foreign inspections they’re making arrangements for that inspector to go over for that inspection, so that’s all they’re there for, [then] they come back. On the domestic side, that inspector may be finishing up with another inspection, or they get called away for a for cause inspection. That said, on average, most domestic and foreign inspections occur in four days or less, sometimes within one day,” Shuren said, according to Regulatory Focus. “As part of this program alignment effort [ORA] is revisiting its SOPs so that it reduces the time for domestic inspections.”

It could be 2 or 3 years before all the changes are in place, Shuren said.

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