21 CFR 821 Medical Device Tracking Requirement

Jen

Starting to get Involved
#1
Hi there, I am wondering how manufacturer are normally fulfil the 21 CFR 821 Medical Device Tracking Requirement? The information FDA (from iii to vii, text in red colour) require a manufacturer to have sound impossible to get hold of.

(a) A manufacturer of a tracked device shall adopt a method of tracking for each such type of device that it distributes that enables a manufacturer to provide FDA with the following information in writing for each tracked device distributed:
(1) Except as required by order under section 518(e) of the act, within 3working days of a request from FDA, prior to the distribution of a tracked device to a patient, the name, address, and telephone number of the distributor, multiple distributor, or final distributor holding the device for distribution and the location of the device;
(2) Within 10 working days of a request from FDA for tracked devices that are intended for use by a single patient over the life of the device, after distribution to or implantation in a patient:
(i) The unique device identifier (UDI), lot number, batch number, model number, or serial number of the device or other identifier necessary to provide for effective tracking of the devices;
(ii) The date the device was shipped by the manufacturer;
(iii) The name, address, telephone number, and social security number (if available) of the patient receiving the device, unless not released by the patient under 821.55(a);

(iv) The date the device was provided to the patient;
(v) The name, mailing address, and telephone number of the prescribing physician;
(vi) The name, mailing address, and telephone number of the physician regularly following the patient if different than the prescribing physician; and

(vii) If applicable, the date the device was explanted and the name,mailing address, and telephone number of the explanting physician; the date of the patient's death; or the date the device was returned to the manufacturer, permanently retired from use, or otherwise permanently disposed of.
 
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yodon

Staff member
Super Moderator
#2
I'm not very familiar with that regulation but just looking at the scope, it seems pretty restricted. Does your device meet the criteria and has the FDA ordered this level of tracking?
 

Jen

Starting to get Involved
#3
Your question prompted me to do more digging on the subject. And turn out FDA actually has issued a list for the medical device that requiring tracking. My device is no on the list! So now I don't have to worry about this requirement anymore. :biglaugh:thank you @yodon :)

For people who interested in the subject, I attached the guidance doc here for your reference.
 

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