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Post-Market Device Issues
FDA’s postmarket regulations follow a medical device from production and processing to packaging and distribution to immediate and long-term performance in the market. Medical device manufacturers must establish and maintain a comprehensive “quality system” to ensure their devices are manufactured consistently to specifications set by FDA, and they must establish and maintain thorough reporting mechanisms to detect, identify and mitigate any device-related problems.
“Those reports are constantly collected, and companies are required to track and trend everything,” says Dr. Susan Alpert. Additionally, FDA is constantly collecting, tracking, and trending its own data.
Together, manufacturers and regulators collect data on facilities involved in the manufacture and distribution of devices; device related incidents, malfunctions, injuries, and deaths; patients who have interacted with the device and more. Every medical device is also assigned a unique device identification (UDI) number, which is specific to a device model and production.
Such data analysis can help manufacturers and regulators together identify the source of a problem. Is the problem a result of user error or design? Is the problem confined to a single batch of devices or is it more widespread? Is the problem confined to a specific patient population or is it a broader issue?
Once manufacturers and regulators define the problem, they together create a solution.
Do clinicians need more or better training with the medical device? Does the product label need to be updated for clarity? Should the product design and/or materials be tweaked to address the issue?
Once these questions are answered, the manufacturer and the regulator work together to implement appropriate corrective action. While FDA has the authority to compel a company to take a corrective action – such as a recall – rarely does the agency have to resort to that.
As Susan says, “If your business is making medical technology, the last thing you want is a product that causes harm in the marketplace with your name on it. So companies are really rigorous in ensuring that their products work properly, safely and consistently.”
Hear from Susan on postmarket regulation in the video below or learn about Postmarket Requirements.
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