US FDA Medical Device Recalls(21 CFR 7 & 810) ,Corrections and Removals (21 CFR 806)

 Voluntary Recall (21 CFR 7)

Manufacturers and distributors shall recall their products if their device present a risk of injury or gross deception or are otherwise defective.

The below figure provides the recall definitions,

Voluntary recall steps are given below,

Recall classification is given below,

Mandatory Device Recalls (21 CFR 810)

1.       Firm not initiated recall when device present a risk of injury or gross deception or are otherwise defective.

2.       FDA issue a recall order to the manufacturer

3.       FDA provide the opportunity for a regulatory hearing in order to modify or amend

4.       If the device present risk to health then FDA may issue a cease distribution and notification order requiring the person named in the order to immediately 

Mandatory Device Recalls (21 CFR 810)

1.       Firm not initiated recall when device present a risk of injury or gross deception or are otherwise defective.

2.       FDA issue a recall order to the manufacturer

3.       FDA provide the opportunity for a regulatory hearing in order to modify or amend

4.       If the device present risk to health then FDA may issue a cease distribution and notification order requiring the person named in the order to immediately

Corrections and Removals (21 CFR 806)

Manufacturer must report to FDA if they make any correction or removal to reduce a risk to health posed by the device . Reports of corrections and removals are required for Class I and Class II recalls.

When to submit to FDA: Within 10 working days from the time the firm initiates the correction or removal.

Manufacturer can submit electronically using  FDA Electronic Submission Software (eSubmitter) or e-mail.

Exceptions:

• If the  information already shared to FDA under Medical Device Reporting (21 CFR 803))
• If the recall was initiated by an FDA order under Medical Device Recall Authority (21 CFR 810)
• Market withdrawals
• Routine servicing, and
• Stock recoveries.

References:

Medical Device Recalls: https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls