Presentation: Post Market Analysis and Reporting, FDA Perspective

The continuum of quality assurance requirements from pre to postmarket
The responsibilities of manufacturers and FDA to ensure continued safety and effectiveness; thresholds of FDA control and action; areas of contention
Reflections on avenues for industry and FDA cooperation

The QC Continuum

Early intervention on design and manufacture of devices
Quality system requirements to help ensure consistently safe and effective devices
Control points to identify and correct mishaps, e.g., nonconforming product, corrective and preventive action, corrections and removals
Annual reports and premarket supplements, MDRs…

Quality System includes Risk Management

A web of bubbles, reading medical device reporting, reports of corrections and removals, corrective & preventive actions, medical device tracking, design controls, production & process controls, sterilization process controls, records / documents / change controls, material controls, facility & equipment controls. In the center are two boxes reading management and risk management system.

Responsibilities

Industry

Management commitment to quality
Control of processes and product
Analyzing signals, investigating nonconformace, identifying and validating action, implementing action, dissemination of information, incorporating changes
Reporting corrections and removals to reduce risk to health, or to remedy a violation (recall)
Adverse effect reporting (MDRs)

FDA

Evaluate and render conclusions on the safety and effectiveness or equivalence of devices that require such action before marketing
Monitor compliance with regulations
Identify postmarket problems from signals and ensure appropriate and timely corrective and preventive action

Monitor recalls
Assess effectiveness of action
Communication

Thresholds of FDA Control and Action

Only certain changes to products require FDA approval or clearance
"Market withdrawals" are not reported but records needed
Most recalls voluntary, few are FDA requested; FDA mandatory recall authority or other actions rarely used and have due process
Usually after the fact FDA assessment of manufacturer recall analyses and actions

Areas of Contention

The Class of a Recall, i.e. 1 or 2
Is a correction or removal associated with a violation (adulteration, misbranding..)
Is an action a recall
Is there a problem, is product within specs, or is it an anticipated product excursion
Scope of problem
Root cause

Working Together

Cooperation between FDA and industry has proven to be the quickest and most reliable means to remove potentially dangerous products from the market
Effective communication between industry and district staff
Quickly and effectively identifying and correcting problems in the quality system and reporting mechanisms
Feedback to improve product quality