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FDA’s Medical Device Safety Action Plan

May 10, 2018

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The Food and Drug Administration (FDA) regulates over 190,000 different medical devices, made by more than 18,000 firms in more than 21,000 facilities worldwide. Many Americans today depend on a medical device in order to maintain their health. Pacemakers, insulin monitors, and heart valves are all commonly used medical devices.

The agency’s oversight obligations include making sure medical devices provide health benefits with as little risk to the users as is possible. FDA approval for a device is based on an assessment of whether it is expected to perform safely based on valid scientific evidence. However, information on risks and benefits before a device reaches the market is limited. The only time we can know if a device performs as expected is after it has reached the market and been used for a period of time by a number of people.

FDA’s Action Plan

The FDA already has a post-market surveillance system to identify new or increased safety concerns, communicate about the concerns, and provide effective interventions. The agency is committed to going further in ensuring the safety of devices. It has recently adopted The Medical Device Safety Action Plan, which presents a strategy to improve the patient safety net, speed access to new devices, and advance medical device cybersecurity nationwide.

Improved Patient Safety Net

The FDA has also introduced a labeling system for most devices. Each label includes a unique device identifier (UDI) that contains information about the device. That information is entered into a database and tracking system called the Global Unique Device Identification System (GUDID). This system is expected to allow more thorough and complete response when dealing with device problems.

So far, the FDA has relied on traditional or passive long-term studies of device performance. The agency is working with a public-private partnership called National Evaluation System for health Technology (NEST) to actively evaluate performance. Using GUDID and advanced data analytics, the enhanced surveillance efforts can improve device oversight and safety throughout the Total Product Life Cycle (TPLC).

Speed Access to New Devices

The FDA plans to consider real-world evidence in making its clearance decisions. This is more expansive than valid scientific evidence, and could enable faster clearance of new devices, or expansion of uses for already approved devices. It is also reorganizing its structure of pre- market and post- market units to better share data and expertise.

Medical Device Cybersecurity

Medical devices are becoming more interconnected, which can improve outcomes. But this renders the devices vulnerable to security breaches. The FDA promotes an approach to cybersecurity that encourages product developers to take precautions in the development stage. FDA advises them to create resilient devices that resist breaches, and to take the proactive approach of designing an upgradable connection that can include patching and updates to protect data security while a device is in use.

Patients deserve the best treatment possible, and that often involves relying on medical devices. Despite new developments in device design and tracking, and the FDA’s Action Plan to improve its oversight, there remains some risk that medical devices can do more harm than good.

Philadelphia Medical Devices Lawyers at Brookman, Rosenberg, Brown & Sandler Represent Patients with FDA Approved Medical Devices

If you or someone you know has had problems with a medical device, contact one of our Philadelphia medical device lawyers at Brookman, Rosenberg, Brown & Sandler for a free consultation. Call us at 215-569-4000 or contact us online. We are centrally located in Philadelphia, Pennsylvania, and we represent clients throughout the surrounding areas.