Postmarket Requirements for Medical Devices: A Practical Guide
35
immediately by the firm for any voluntary recall,
and foreign manufacturers and importers are
required to contact the local recall division for
their US agents. In cases where the manufacturer
or importer fails to voluntarily recall a device that
is defective or presents a risk of injury or gross
deception, FDA may issue a mandatory recall
order to the manufacturer under 21 CFR 810.32
Relevant FDA regulations pertaining to
device recall (corrections, removals) procedures
fall under the following statutory requirements:
• 21 CFR 7: Enforcement Policy, particularly
Subpart C—contains FDA guidance on
recalls and product corrections and is for
voluntary recalls
• 21 CFR 806: Medical Device Corrections
and Recalls—contains the notification
requirements for medical device corrections
and recalls.
• 21 CFR 810: Mandatory Device Recall—
includes the recall authority provisions
A medical device recall does not mean that a user
needs to stop using the product or return it to the
Table 2-3. Mandatory Reporting Requirements25
Reporter What to Report
When to report (after
becoming aware of an
event)
To Whom to
Report
FDA Report Form
Number
Manufacturer
(21 CFR Part 803.50)
Device-related death or
serious injury
Within 30 calendar
days
FDA Form FDA 3500A
or electronic
equivalent
Manufacturer
(21 CFR Part 803.50)
Device malfunctions Within 30 calendar
days
FDA Form FDA 3500A
or electronic
equivalent
Manufacturer
(21 CFR Part 803.53)
Incident or event that
requires immediate reme-
dial action
Within five working
days
FDA Form FDA 3500A
or electronic
equivalent
Device User Facilities
(21 CFR Part 803.32)
Device-related death in
the facility
Within 10 working
days
FDA and the
manufacturer
Form FDA 3500A
or electronic
equivalent
Device User Facilities
(21 CFR Part 803.32)
Device related serious
injury
Within 10 working
days
FDA or
manufacturer
(FDA only if the
manufacturer is
unknown)
Form FDA 3500A
or electronic
equivalent
Device User Facilities
(21 CFR Part 803.33)
Annual reports of death
and serious injury filed
January 1 through 31
December
(Note: Annual summary
report should not be
submitted if there were
no adverse events during
the reporting period.)
No later than 1
January of each year
FDA Annual User
Facility Form
3419 or electronic
equivalent
Importers
(21 CFR Part 803.40)
Device-related death or
serious injury
Within 30 calendar
days
FDA and the
manufacturer
Form FDA 3500A
or electronic
equivalent
Importers
(21 CFR Part 803.40)
Device related
malfunctions
Within 30 calendar
days
Manufacturer Form FDA 3500A
or electronic
equivalent