Postmarket Requirements for Medical Devices: A Practical Guide
39
field corrections, and recall termination in
the FDA Enforcement Report. Weekly FDA
Enforcement Reports can be found at https://
www.fda.gov/inspections-compliance-en-
forcement-and-criminal-investigations/
compliance-actions-and-activities. See Figure
2-5 for an overview of the recall process.
Medical Device Tracking
21 CFR 82140
On 27 March 2014, FDA finalized guidance
on medical device tracking.41 This document
describes the procedures surrounding medical
device tracking requirements and provides FDA
with the authority to order Class II or Class III
device manufacturers to establish a device track-
ing system if a device meets any of the following
listed criteria:
• The device failure may result in a serious
adverse health consequence.
• The device is intended to be an implantable
device for more than one year, such as a
pacemaker, heart valve, breast prosthesis, etc.
• Life-sustaining or life-supporting device
used outside a user facility, such as breath-
ing facilitator monitors, continuous
Figure 2-5. Overview of Recall Process
Step 1: Identification of a potential noncompliance issue
Voluntary Recall 21 CFR Part 7
Recall initiated by manufacturer
or distributor
Mandatory Recall 21 CFR Part 810
Statutory recall requested by the FDA
Received by Manufacturer/Distributor
Step 2: Communication to FDA by the recalling firm
Step 6: Development of the recall strategy by the
firm followed by submission to the FDA
Step 4: Based on the HHE, FDA assigns the recall classification
Step 8: Submission of periodic recall status
report by the recalling firm to FDA
Note: The reporting period is generally between 2 and 4 weeks.
Step 3: Health Hazard Evaluation (HHE) by FDA
Step 7: Public notification of recall
Step 5: Investigation of the product, root cause
identification, CAPA, and documentation
Step 9: Reconciliation and disposition of the recalled batch (if any)
Step 10: Closure of recall (recall termination)
Recall Strategy
Recall termination by FDA once
FDA determines that efforts have
been made to remove or correct the
product per the recall strategy.
39
field corrections, and recall termination in
the FDA Enforcement Report. Weekly FDA
Enforcement Reports can be found at https://
www.fda.gov/inspections-compliance-en-
forcement-and-criminal-investigations/
compliance-actions-and-activities. See Figure
2-5 for an overview of the recall process.
Medical Device Tracking
21 CFR 82140
On 27 March 2014, FDA finalized guidance
on medical device tracking.41 This document
describes the procedures surrounding medical
device tracking requirements and provides FDA
with the authority to order Class II or Class III
device manufacturers to establish a device track-
ing system if a device meets any of the following
listed criteria:
• The device failure may result in a serious
adverse health consequence.
• The device is intended to be an implantable
device for more than one year, such as a
pacemaker, heart valve, breast prosthesis, etc.
• Life-sustaining or life-supporting device
used outside a user facility, such as breath-
ing facilitator monitors, continuous
Figure 2-5. Overview of Recall Process
Step 1: Identification of a potential noncompliance issue
Voluntary Recall 21 CFR Part 7
Recall initiated by manufacturer
or distributor
Mandatory Recall 21 CFR Part 810
Statutory recall requested by the FDA
Received by Manufacturer/Distributor
Step 2: Communication to FDA by the recalling firm
Step 6: Development of the recall strategy by the
firm followed by submission to the FDA
Step 4: Based on the HHE, FDA assigns the recall classification
Step 8: Submission of periodic recall status
report by the recalling firm to FDA
Note: The reporting period is generally between 2 and 4 weeks.
Step 3: Health Hazard Evaluation (HHE) by FDA
Step 7: Public notification of recall
Step 5: Investigation of the product, root cause
identification, CAPA, and documentation
Step 9: Reconciliation and disposition of the recalled batch (if any)
Step 10: Closure of recall (recall termination)
Recall Strategy
Recall termination by FDA once
FDA determines that efforts have
been made to remove or correct the
product per the recall strategy.