Medical Device Recall: How does USFDA recall Medical Device works?

Medical devices, unlike prescription drugs, are reviewed by the United States (US) Food and Drug Administration (FDA) under one of two regulatory standards – Premarket approval (PMA), which requires clinical testing and inspections, or the 510(k) process, which does not. The second standard is intended for devices with a low or no risk of failure, as determined by the FDA. The medical device must be similar to a previously marketed device (predicate device).

Introduction

The FDA categorizes medical devices into one of three categories based on the level of control required to ensure the safety and effectiveness of the device and the level of risk the device poses to patients.

Class I devices pose the least risk and are subject to minimal regulation — examples: tongue depressors, bandages, crutches, stethoscopes, and bandages.

Class II devices pose a moderate risk and may be cleared through the 510(k) premarket notification process, which allows them to be marketed if they are substantially equivalent to a predicate device. Examples – electrocardiographs, contact lens solutions, hearing aids, and orthopaedic drills.

(Notably, clinical trials are not required for device classes I and II)

The FDA defines Class III devices as posing the greatest potential risk. They are defined as devices that “support or sustain human life, play a significant role in preventing human health impairment, or pose an unreasonable risk of illness or injury.” Example – implantable pacemakers, stents, heart valves, and human immunodeficiency virus diagnostic tests. Although implants and devices that prevent health impairment are supposed to be Class III, many hip and knee implants are Class II.

The majority of Class I and some Class II devices are exempt from premarket review and the majority of manufacturing practices regulations. For such devices, companies do not need to apply to the FDA for review or clearance of exempt devices; instead, they must simply notify the FDA that they are selling the products. The 510(k) premarket notification process is used for Class II devices considered to be of intermediate risk. According to the FDA, a more stringent premarket approval (PMA) review process is required to ensure the safety and effectiveness of Class III devices.

The FDA initiates recall for products that do not receive approval through the PMA process. Occasionally, the manufacturer discovers a flaw in a medical device and issues a recall.

What is a Recall?

A recall is considered the most effective preventive measure to protect the public when a medical device or any product in that sense is defective or can be harmful to people. According to the FDA, a recall is a process of removing or correcting products that have violated USFDA law by causing harm or deviating from the way they are intended to be used.

Below is the list of products that are subjected to recall by the FDA

• Drugs/Medicines/Vaccines related to Human and animals
• Implantable Medical devices
• Transfusions like Blood and blood products
• Radiation-emitting products
• Transplantable human tissue
• Animal feed
• Cosmetics
• Food

In other words, what happens when you neglect Quality Assurance? This is where patient safety begins. For example, the National Cancer Institute went through one of the worst software disasters when a bug destroyed their radiology equipment. Due to this, their devices administered radiation doses 100 times higher than required.

Quality leaders must invest in proper validation to implement best practices to ensure patient safety. Testing efforts should start as early as possible. Speaking, the sooner we find a bug, the cheaper it will be to fix it.

Read more : https://www.complianceg.com/fda-medical-device-recall/