Warning Letter: Post Market Surveillance Remediation

Background

Our client, a large medical device company, was challenged with significant Post Market Surveillance issues after receiving a 483 and subsequent Warning Letter from the United States Food and Drug Administration (FDA). The organization received multiple observations for deficiencies related to:

• Failure to submit a report to FDA no later than 30 calendar days after the day that the firm received or otherwise became aware of the information, including failure to identify all sources of potential complaints.
• Failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as per 21 CFR 820.198(a).
• Failure to properly assess complaints for reportability due to precedent events and recalls.

Approach and Solution

The company remediation plan proposed to update procedures and reportability tools, establish interim controls for monitoring, and initiate multiple protocols to address the observations. These protocols addressed a combined review, assessment, update, and potential Medical Device Reporting submission of approximately 163,953 complaint files. ECI provided the following:

• Project Management support for all remediation activities.
• Provided 80 remediation resources to address observations.
• Provided 45 resources to support daily complaint monitoring.

Remediation occurred in parallel with continued daily complaint processing and during the acquisition of the firm. Significant training was required to maintain sustaining capabilities to address gaps found within the complaint process analyses and process updates.

Numerous subject matter experts were deployed for a 24-month engagement. The project team supported the remediation effort with the following tasks and activities:

• Daily Complaint Support
• Post Market Quality Management System Alignment Process
• Verification of Correct Complaint Code(s) per the Reporting Tool
• Closure of all Open Complaint Files
• Application Support Record Review

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Comprehensive Action

Following the initiation of multiple Corrective and Preventive Actions (CAPAs), an ECI subject matter expert performed a deep dive assessment to identify additional regulatory deficiencies.

Although the primary scope of the review was FDA regulations due to the Warning Letter, the assessment also considered international regulatory requirements.

• FDA: 21 CFR 803.17, subparts for Medical Device Reporting, 21 CFR 820.198 (a-g) (Subpart M)
• International: ISO 13485:2016, EU MDR 2017/745

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Results

The client's Post Market Surveillance processes are in the process of being brought into compliance through an efficient, cost-effective effort. Prolific support from the ECI team for the remediation effort included:

• 100: approximate number of documents reviewed during Post Market Quality Management System Alignment gap assessment.
• 2,058: total number of complaints identified and initiated during retrospective review of 2.5-years of Application Support logs (6,971) assessed for possible complaints.
• 8,330: total number of new/supplemental Medical Device Reports submitted to the FDA during retrospective review of 49-months of closed complaint files to verify correct complaint code(s) per the reporting tool.
• 57,732: number of open complaint files reassessed per respective regulations with progression to closure upon submittal of all required reports.
• 79,990: number of previously closed complaint files re-opened, re-coded, re-assessed for reportability utilizing updated Reporting Tools and procedures and re-closed during retrospective review of 49-months of closed complaint files to verify correct complaint code(s) per the reporting tool.

Continuing use of the complaint processing procedures and templates developed by ECI during this project has resulted in leaner, compliant operations for our client.