Warning Letter: Regulatory Responsibility

Background

Our client, a large medical device company, received several 483 inspectional observations and a subsequent Warning Letter from the United States Food and Drug Administration (FDA). There were numerous inspection observations for deficiencies and significant violations of the US regulations cited by FDA related to the areas of the client's Quality Management System (QMS).

• Design Control and Risk Management (US 21 CFR 820.30, ISO 14971)
• Nonconforming Product and Corrective and Preventive Action (US 21 CFR 820.90, 820.100)
• Post Market Surveillance (US 21 CFR 803.17, 820.198, Medical Device Reporting)
• Field Actions (US 21 CFR 806)

Approach and Solution

ECl's team of expert consultants with strong experience in remediation, some of which are former FDA regulatory staff, served as subject matter experts for the client. The assembled team provided expert consultation and review of the company Warning Letter response to ensure a robust proposal for each cited violation to achieve regulatory compliance.

An overall Quality Management System assessment plan was established and proposed to assess the current documentation against the regulations. ECI established a remediation plan to update applicable Quality Management System procedures, as well as interim controls for monitoring, and defined specific activities to address the violations.

Regulatory strategy was defined to address device corrections and ensure successful submission of necessary corrective device changes as well as re-baseline device marketing clearance/approval through submission of pre-market notifications.

‍

Comprehensive Action

Although the primary scope of the review was FDA regulations due to the Warning Letter, the assessment also considered international requirements, specifically ISO 13485:2016, European Union Medical Device Directive, and European Union Medical Device Regulation EU MDR 2017/745.

‍

Results

A remediation plan was established to update procedures, as well as establish interim controls for monitoring, and defined specific activities to address the violations. Several product remediation plans were also proposed to address cited Warning Letter violations with respect to device adulteration and misbranding, within the meaning of the act per section501(h) of the Food, Drug, and Cosmetic Act, 21 U.S.C. S351(h).

A comprehensive strategy was defined to account for a risk assessment and to minimize the impact on clinical practice while pursuing an effective product market withdrawal as necessary.

The company held a meeting with the FDA Office of Compliance and communicated a proposed completion date for its pending remediation activities. They continue to demonstrate progress to meet the forecasted completion date. The agency indicated they will return after the completion date for its next series of FDA inspections.