FDA 21 CFR -Part 821 Medical Device Tracking Requirements

The device should be intended to be implanted in the human body for over a year.

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Medical Device Tracking is a very important aspect of the distribution chain of a medical device. This is because it is critical to have a mechanism by which a medical device can be traced and located in its place after it leaves the manufacturer. This system of tracking helps to identify a defective device and ensure that corrective measures are taken immediately. This helps minimize damage, which could range from minor to fatal, depending on the kind of medical device in question.

21cfrPart821MedicalDeviceTrackingRequirementsThe 21 CFR -Part 821 medical device tracking requirements

The FDA’s 21 CFR -Part 821, which became effective in August 1993, is dedicated to medical device tracking requirements. This section requires manufacturers to maintain a system by which they can track the movement of either Class II or Class III devices once they have left the manufacturer’s facility. Tracking is considered the first step for further actions from the FDA, such as mandatory recalls.

Important factors for enforcing 21 CFR -Part 821 medical device tracking requirements 21 CFR -Part 821 medical device tracking requirements have guidelines on the steps that manufacturers must take in order to ensure that they are able to track medical devices after they have left the manufacturer’s facility. These are usually the factors:

  • Failure to track and recall the device should be quite likely to lead to adverse, serious health consequences;
  • The device should be intended to be implanted in the human body for over a year;
  • They should be life-sustaining or life-supporting devices that are put to use in a place outside of a device user facility.

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The Modernization ActThe Modernization Act, which became effective in February 1998, gives the FDA the discretion to decide which manufacturers of certain types of Class II or Class III devices should be part of its program for track their medical devices. By the terms of The Modernization Act, patients whose devices are tracked are not obliged to release details such as their social security number, name, address, or any other identifying information towards tracking.

Duration of tracking is left to the FDAPer 21 CFR -Part 821 medical device tracking requirements, the FDA will decide for how long a manufacturer’s device is being tracked. It will inform the manufacturer when it has decided to stop this activity.

How should manufacturers meet 21 CFR -Part 821 medical device tracking requirements?All manufacturers whose devices are being tracked must establish a written standard operating procedure (SOP). A clearly notified method for tracking the device throughout the distribution channel and a quality assurance program that is inclusive of audit procedures should be part of this undertaking.

Author: compliance4all

Compliance4All, the ultimate continuing professional education provider offers you regulatory and compliance trainings from the industry's leading experts, but with one crucial difference -the cost. Compliance4All's objective is to be a platform that provides regulatory and compliance trainings with all the class and features that come with these trainings, at a lower price. Compliance4All seeks to make regulatory and compliance trainings low-hanging fruits. Industries We Focus On: • Trade & Logistics • Aerospace Defense • Banking & Insurance • Food & Beverages • Auditing/Accounting & Tax • Energy • Environment • Education • Automotive Transport • Science and Technology • Government • Construction • Electronics & Semiconductor • Operation • Engineering/Science • Purchasing & Vendor Relation • General counsel/Accountant • Geology & Mining • Documentation/Records

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