Stay Compliant: The FDA's New Medical Tracking System

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Stay Compliant:The FDA's New Medical Tracking System

To be sure that patient safety remains a top priority, the FDA is instigating a new Medical Tracking System for all medical devices by utilizing a unique device identification (UDI) system. Medical devices and their various versions will receive a UDI that can track a product's batch number, expiration date, and manufacturing date.

The UDI's will be supplemented by a searchable database constructed by the FDA to be used as a reference catalog. The FDA has made it clear that though the database will be public, there will be absolutely zero patient data included on the site and the individual usage of the devices will remain private.

The Benefits of UDI

How will this help? For one, flawed devices coming from bad batches will be recalled easily, reducing the magnitude of a mass recall should one occur. It should also make counterfeits more easily routed out with the database within such convenient reach. The real benefit will likely be the unilateral surveillance methods imposed by the FDA to be sure devices remain truly up to snuff, and the market analysis techniques that will undoubtedly follow.

When We'll See It

Similar to the process of actually developing medical devices, the tracking system will take a few years to fully hit the market. The UDI's slow rollout starts with Class III medical devices (those considered to be necessary to support or sustain human life, like external defibrillators and HIV diagnostic tests) to require tracking information by September 24, 2014, exactly one year after the announcement was made. Class II's will require UDI's by 2016, and Class I's by 2018.

Why We'll See It

For any manufacturer creating a medical device, the impact of being slammed with compliance requirements is one to both expect and respect. Those compliances, both in specific part usage (like RoHS) and the manufacturing/distribution process (QS Regulation), are in place to ensure a patient's health remains in its utmost achievability. It's never a simple or easy process when there are plenty of other rules to heed, but the main reason behind UDI is a restating of the obvious: a revolutionary device can be the decider between life and death for a patient, and the FDA wants to be sure device makers remain thoughtful to their patient's safety.

Arena's Take

With the stricter regulatory measures in place, medical device manufacturers will be held more responsible for their products' shortcomings should they surface. That responsibility includes the potential of a recall, where manufacturers will be able to address problems with specific batches in a swift and more economically viable manner. When the time comes to pinpoint what exactly went wrong, the need for product records with easy backtracking and accessibility will become more crucial than ever. The pressure will stay on manufacturers to meet compliances with total precision and ensure that the patients using their products receive the best care that they can.

You can read more about it at the FDA's website here.

To discover how Arena's cloud PLM features help to streamline FDA Audit Compliance, Enterprise Change Management, and Verification and Validation please click here. In addition, Arena offers a Validation Maintenance Service (Arena BOMControl is “part 11 ready” and VALIDATED (via VMS) designed to meet the specific regulation challenges of medical device companies.

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About the Author

Brett Grossfeld
Brett Grossfeld joined the Arena team to help round out the company's marketing efforts. Having been fostered by prestigious writing programs at Stanford University and UC Santa Cruz, Brett helped ... Read More 

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