FDA Lays Out Plan to Improve Medical Device OversightThousands of people across the country rely on medical devices to keep them healthy. Medical devices such as implants, heart pacemakers, prosthetics, and birth control devices, have revolutionized health care. However, when these devices are defective in some way they can cause serious injuries to patients. The Food and Drug Administration (FDA) is responsible for ensuring that medical devices on the market are safe for patients.

FDA Oversight

Medical devices are required to be properly tested and researched before they are placed on the market. Under the FDA approval process, medical devices go through years of testing and clinical trials before they are approved for widespread use. After devices are placed on the market and are used by patients, the FDA typically took a passive approach to recalls. The FDA would wait for reports of device defects from users before initiating an investigation or starting the recall process. The FDA has been criticized for its oversight and is now looking to take a more active role.

Improvements in Oversight

The FDA is now looking to implement a plan that will make the agency among the first to identify and act upon safety issues with medical devices. The agency has already been increasing its enforcement actions, and there has been an uptick on the number of devices recalled. Over the last decade, the FDA has increased inspections by 46%. The FDA has also taken steps to focus on the quality of medical devices and not just their compliance with standards.
The agency now plans to implement a new active surveillance system when it comes to medical devices on the market. This system will look beyond complaints by device users and focus on real-world evidence of safety concerns. At times this may require a manufacturer to conduct further testing regarding specific concerns in order to make improvements in the safety of a device. Improved oversight of medical devices on the market should hopefully keep device manufacturers accountable for defective products.

Contact an Experienced Attorney

If you have been injured by a defective medical device, you should have an experienced personal injury attorney evaluate your case. At Bonina & Bonina, P.C., we have over 50 years of experience helping New Yorkers injured by defective products. Contact us online or call us at 1-888-MEDLAW1 to schedule your free consultation. Home and hospital visits are available. Se habla español.