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Compliance 360° Part 7: Factors Feeding Your Inspection Cycle – A New Paradigm

Executive Summary

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this seventh installment, former FDA investigations branch director Ricki Chase explains how new initiatives within the agency and center for devices – including FDA's in-the-works "program alignment" inspection initiative, may affect your facility audits. Also discussed: the Medical Device Single Audit Program (MDSAP), the joint FDA/Medical Device Innovation Consortium (MDIC) Case for Quality, and FDA's Voluntary Compliance Improvement Program (VCIP).

Device-makers that manufacture high-risk products or have risky manufacturing operations will likely be inspected more often under US FDA's in-the-works "program alignment" inspection initiative, a former FDA investigations branch director says.

"Program alignment, when it is fully launched, will most likely have the most immediate, noticeable impact on inspectional frequency and exposure," Ricki Chase says in the seventh installment of Compliance 360°, a podcast series from Medtech Insight on FDA compliance and enforcement issues. (Scroll to the bottom to find the podcast player.)

Under program alignment, facility inspections performed by the Office of Regulatory Affairs (ORA) will be structured along commodity-specific product lines – a historic change for the office, which conducts all of the agency's field activities. One of the plan’s goals is to make inspections more predictable and consistent for investigators and manufacturers.

The inspection scheme calls for the agency’s five regional offices to be replaced by three distinct districts within the US. (Also see "Kiss Your FDA Regional Office Goodbye: Big Changes Afoot Thanks To ORA’s Inspectional Program Alignment" - Medtech Insight, 21 Mar, 2016.) Further, Boston, Florida and Los Angeles will likely be home to new FDA divisions dedicated to coordinating inspections under the initiative, a longtime industry insider recently told Medtech Insight in a separate podcast. (Also see "Podcast: FDA’s Inspection ‘Program Alignment,’ New Guidance Docs Top QA/RA Hotspots In 2017" - Medtech Insight, 1 Feb, 2017.)

Program alignment will change how FDA selects companies to inspect, Chase says. "Much like the center for drugs, the center for devices is moving to a risk-based assessment of the medical device inventory. The assessment may include factors such as previous regulatory actions, time since the last inspection, [whether] the firm has never been inspected, serious recalls, numbers and types of complaints, new product to market, and indications from Medical Device Reports."

A risk score will be compiled by the agency, and firms with high scores might undergo more audits.

"Because the inspectional decisions will be based on risk and not on geographical distribution across districts, the personnel resources may be drawn from the national pool of all medical device investigators. In practicality, this may look like a firm with an inherently high-risk device or operation being subject to more frequent inspection regardless of compliance history," Chase says.

Skip To…

  • MDSAP (@ 2:46)
  • Case for Quality (@ 4:41)
  • VCIP (@ 5:55)
  • Program alignment (@ 7:21)

In the latest installment of Compliance 360°, Chase also explains how other initiatives within the agency and center for devices may affect your facility inspections, including the Medical Device Single Audit Program (MDSAP), the joint FDA/Medical Device Innovation Consortium (MDIC) Case for Quality, and FDA's Voluntary Compliance Improvement Program (VCIP).

"In my opinion, the key to successful navigation [of these changes being made by the agency] is patience, early and good communication, and a willingness to be a part of the ongoing process improvement by providing tactful feedback, and industry suggestions and solutions," she says.

Chase is compliance practice director for Lachman Consultant Services, a firm she joined in June 2016 after spending 16 years at FDA, where she was also an investigator, medical device specialist and supervisory investigator.

Listen to the podcast via the player below:

 

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