Originally Published MDDI February 2005

NEWSTRENDS

Want a Quick PMA Process? Be Ready for Inspection

Erik Swain

By law, the CDRH Office of Compliance is supposed to conduct PMA-related inspections speedily. But it can only do so, the office's director said last November, if the company to be inspected is prepared.

Under MDUFMA, the Office of Compliance has 30 days to review a PMA application's manufacturing section (20 days for an expedited PMA) and 45 days to conduct an inspection (60 if at a foreign site). It then has 30 days to complete an inspection report and 30 days to review that report (20 for an expedited PMA), Timothy

Ulatowski, CDRH compliance director, told attendees at the MDUFMA stakeholders meeting.

The biggest obstacle to meeting those goals, he said, comes when a firm is not ready for inspection. “We do biweekly reviews of each activity carried out by our office,” he said. “There, we review what PMA inspections and manufacturing section reviews we have to do. In some months, 100% of the inspections in the queue are of firms that are not ready for inspection. In some cases, it takes months before they are ready. This is an issue we have to deal with.”

The office can sign off on the manufacturing section of a PMA application before an inspection by making an “approvable pending GMP” decision. However, the office is struggling with “how and when to apply [this sign-off process],” Ulatowski said. “We want to apply it in a way that [ensures] there is no gamesmanship.”

The office takes the issue very seriously, he noted. “This is the key priority of the office. As an example of our commitment, we set up district PMA coordinators to monitor the PMA inspection process in the individual districts and identify people that we need to shepherd.” A number of hours have been spent training inspectors on the law, he said.

“The agency will put a lot of effort into bringing together the review process and the compliance process more effectively,” he said.

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