Source: https://www.compliance4all.com/control/21-cfr-part-821-medical-device-tracking-requirements
Timestamp: 2017-05-23 20:38:26
Document Index: 97379914

Matched Legal Cases: ['art 821', 'art 821', 'art 821', 'art 821', 'art 821', 'art 821', 'art 821']

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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:
The 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 FDA
Per 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.