Section I: North America: United States and Canada
Chapter 2: Postmarket Compliance: US
38
• Product details
• Contact details (name and telephone num-
ber) of the company official
• Rationale for the removal or correction
• The date and scenario under which the
product deficiency or possible product defi-
ciency was identified
• Risk evaluation associated with the defi-
ciency or possible deficiency
• Total number of affected devices produced/
in distribution
• Details of the distributed product
• A copy of the issued or proposed recall
communication
º Proposed recall strategy
A recall strategy is developed per 21
CFR 7.4238 once a firm decides to recall
a device. There are many factors to con-
sider when developing a recall strategy.
Some of these factors are HHE results,
ease of identifying a product, degree
to which a consumer can identify the
deficiency, degree to which a product
remains unused in the market, and the
continuous availability of essential prod-
ucts. The objective of a recall strategy
is to include the following information
with respect to the conduct of the
recall:38
• Recall depth: The recall strategy should
clearly identify the level of distribution, such
as user level, retail level, or wholesale level.
• Public warning: A public warning such as a
general public warning (general news media,
either national or local) or through spe-
cialized modes (professional or trade press)
should be initiated for urgent recalls to alert
the public that the product poses a serious
health hazard.
• Effectiveness check: It is required to confirm
that all consignees were made aware of the
recall. Various methods are used for effec-
tiveness checks, such as phone calls, personal
visits, letters, etc. The level of effectiveness
checks to be conducted are as follows:
º Level A: 100% consignees to be
contacted
º Level B: Some percentage of consignees
to be contacted (the determination is
made on a case-by-case basis generally,
it falls under the range of more than
10% but less than 100% of the total
number of consignees)
º Level C: 10% of the total consignees to
be contacted
º Level D: 2% of the total consignees to
be contacted
º Level E: No effectiveness check
Step 2—Recall monitoring and status updates:
A follow-up should be conducted with the
consignee as necessary. Consignees that receive
a recall notification should immediately follow
the instructions specified by the recall firm and, if
necessary, extend the recall to its consignee.
The recall firm is required to submit a peri-
odic status update report to an FDA district office
to provide a progress report to FDA. The report-
ing frequency is generally between two and four
weeks unless otherwise specified (21 CFR 7.53).
Step 3—Recall Termination: A recalling firm
can submit a written request to FDA’s district
office, also known as CDRH’s Office of Regional
Division (ORD), to terminate a recall if they
believe that all recall activity has been completed
and the recall is effective. Such requests should
include the most current recall status report and
details of the disposition of the recalled product.
Also, FDA can terminate a recall by sending a
written notification to the recalling firm once
FDA determines that appropriate actions have
been taken by the recall firm to correct or remove
the violative product in accordance with the
recall strategy, and disposition and corrections
have been commensurate with the product haz-
ard (21 CFR 7.55).39
After a recall is completed, FDA ensures
that the violative product is destroyed or recon-
ditioned. FDA also investigates why the product
was defective in the first place. FDA evaluates the
effectiveness of a recall by reviewing the actions
taken by the firm to ensure the harmful prod-
uct has been removed from the market. If FDA
determines that the recall is ineffective, FDA will
request that the firm take additional actions.
FDA also is responsible for publishing
all enforcement actions, including recalls,
Chapter 2: Postmarket Compliance: US
38
• Product details
• Contact details (name and telephone num-
ber) of the company official
• Rationale for the removal or correction
• The date and scenario under which the
product deficiency or possible product defi-
ciency was identified
• Risk evaluation associated with the defi-
ciency or possible deficiency
• Total number of affected devices produced/
in distribution
• Details of the distributed product
• A copy of the issued or proposed recall
communication
º Proposed recall strategy
A recall strategy is developed per 21
CFR 7.4238 once a firm decides to recall
a device. There are many factors to con-
sider when developing a recall strategy.
Some of these factors are HHE results,
ease of identifying a product, degree
to which a consumer can identify the
deficiency, degree to which a product
remains unused in the market, and the
continuous availability of essential prod-
ucts. The objective of a recall strategy
is to include the following information
with respect to the conduct of the
recall:38
• Recall depth: The recall strategy should
clearly identify the level of distribution, such
as user level, retail level, or wholesale level.
• Public warning: A public warning such as a
general public warning (general news media,
either national or local) or through spe-
cialized modes (professional or trade press)
should be initiated for urgent recalls to alert
the public that the product poses a serious
health hazard.
• Effectiveness check: It is required to confirm
that all consignees were made aware of the
recall. Various methods are used for effec-
tiveness checks, such as phone calls, personal
visits, letters, etc. The level of effectiveness
checks to be conducted are as follows:
º Level A: 100% consignees to be
contacted
º Level B: Some percentage of consignees
to be contacted (the determination is
made on a case-by-case basis generally,
it falls under the range of more than
10% but less than 100% of the total
number of consignees)
º Level C: 10% of the total consignees to
be contacted
º Level D: 2% of the total consignees to
be contacted
º Level E: No effectiveness check
Step 2—Recall monitoring and status updates:
A follow-up should be conducted with the
consignee as necessary. Consignees that receive
a recall notification should immediately follow
the instructions specified by the recall firm and, if
necessary, extend the recall to its consignee.
The recall firm is required to submit a peri-
odic status update report to an FDA district office
to provide a progress report to FDA. The report-
ing frequency is generally between two and four
weeks unless otherwise specified (21 CFR 7.53).
Step 3—Recall Termination: A recalling firm
can submit a written request to FDA’s district
office, also known as CDRH’s Office of Regional
Division (ORD), to terminate a recall if they
believe that all recall activity has been completed
and the recall is effective. Such requests should
include the most current recall status report and
details of the disposition of the recalled product.
Also, FDA can terminate a recall by sending a
written notification to the recalling firm once
FDA determines that appropriate actions have
been taken by the recall firm to correct or remove
the violative product in accordance with the
recall strategy, and disposition and corrections
have been commensurate with the product haz-
ard (21 CFR 7.55).39
After a recall is completed, FDA ensures
that the violative product is destroyed or recon-
ditioned. FDA also investigates why the product
was defective in the first place. FDA evaluates the
effectiveness of a recall by reviewing the actions
taken by the firm to ensure the harmful prod-
uct has been removed from the market. If FDA
determines that the recall is ineffective, FDA will
request that the firm take additional actions.
FDA also is responsible for publishing
all enforcement actions, including recalls,