Postmarket Requirements for Medical Devices: A Practical Guide
31
Administrative Actions
FDA Inspections
FDA conducts inspection of medical device
manufacturing facilities, including domestic
manufacturers, contract testing laboratories,
clinical study sponsors, investigator sites, foreign
companies, and contract research organiza-
tions (CRO) to ensure regulatory compliance.
FDA may conduct either a routine inspection
or a for-cause inspection to ensure GMP/QSR
compliance (routine surveillance, establishment
license or pre-approval), GLP compliance, or
GCP compliance (sponsor or investigational
sites). Generally, an FDA inspection of a man-
ufacturing facility is required prior to a PMA
approval for a Class III device, referred to as
prior approval inspection (PAI).
FDA may not inspect a firm’s sales data,
with the exception of shipment information,
financial and pricing information, personnel files
other than qualifications, internal audit files, and
research data other than those subject to FDA
inspection. An FDA inspector is required to
produce a Notice of Inspection (FDA Form 482),
along with its credentials, to the manufacturing
site prior to inspection initiation.
FDA Form 483
In case of any observations that may constitute
violation of the FD&C Act, FDA may issue
inspectional observations to the management
on FDA Form 483 at the end of the inspection.
FDA Form 483 is discussed with the senior
management of the firm, and it not a final
determination of whether or not any condition
observed is in violation of the FD&C Act.
Upon the receipt of FDA Form 483, a
firm has 15 working days to provide a written
response to FDA with an extensive corrective
action plan.
Recalls
Defined as an action taken by a manufacturer,
importer, or distributor of a medical device to
remove a violative or defective product from the
market. Recalls may be initiated by a firm volun-
tarily, by formal FDA request, or by FDA order
under FDA’s mandatory recall authority. Recalls
are discussed in detail later in this chapter.
Enforcement Actions
Product Seizure
An action intended to remove a violative product
from commercial distribution. FDA initiates the
seizure process by filing a complaint to the US
court where the product is located. A US Marshall
as directed by the court seizes the products where
they are found until the issue is resolved.
Injunction
An order by the court that requires an individ-
ual or firm to halt the continued production or
distribution of a violative product until the indi-
vidual or firm complies with FDA regulations.
Criminal Prosecutions: An action taken
by FDA’s Office of Criminal Investigation17
to conduct criminal investigations against the
individual or firm responsible for illegal activities
involving an FDA-regulated product. They also
are responsible for arresting and bringing them
to the US Department of Justice for prosecu-
tion. Criminal prosecution is recommended for
products that are in violation of Section 301 of
the FD&C Act. 19
There are two types of criminal prosecutions
under Section 301 of the FD&C Act:
• Misdemeanor convictions: These types of
convictions do not require any evidence for
the violation of the FD&C Act. It can result
in fines and/or imprisonment up to one year.
• Felony convictions: It is applicable in
the case of a second violation or intent to
defraud or mislead. It can result in fines and/
or imprisonment for up to three years.
Postmarket surveillance studies are available
on the FDA database (https://www.accessdata.
fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm,)
which is updated on the fifth of every month.
Furthermore, protocols and final study reports
can be requested from FDA under the Freedom
of Information Act (FOIA).20
31
Administrative Actions
FDA Inspections
FDA conducts inspection of medical device
manufacturing facilities, including domestic
manufacturers, contract testing laboratories,
clinical study sponsors, investigator sites, foreign
companies, and contract research organiza-
tions (CRO) to ensure regulatory compliance.
FDA may conduct either a routine inspection
or a for-cause inspection to ensure GMP/QSR
compliance (routine surveillance, establishment
license or pre-approval), GLP compliance, or
GCP compliance (sponsor or investigational
sites). Generally, an FDA inspection of a man-
ufacturing facility is required prior to a PMA
approval for a Class III device, referred to as
prior approval inspection (PAI).
FDA may not inspect a firm’s sales data,
with the exception of shipment information,
financial and pricing information, personnel files
other than qualifications, internal audit files, and
research data other than those subject to FDA
inspection. An FDA inspector is required to
produce a Notice of Inspection (FDA Form 482),
along with its credentials, to the manufacturing
site prior to inspection initiation.
FDA Form 483
In case of any observations that may constitute
violation of the FD&C Act, FDA may issue
inspectional observations to the management
on FDA Form 483 at the end of the inspection.
FDA Form 483 is discussed with the senior
management of the firm, and it not a final
determination of whether or not any condition
observed is in violation of the FD&C Act.
Upon the receipt of FDA Form 483, a
firm has 15 working days to provide a written
response to FDA with an extensive corrective
action plan.
Recalls
Defined as an action taken by a manufacturer,
importer, or distributor of a medical device to
remove a violative or defective product from the
market. Recalls may be initiated by a firm volun-
tarily, by formal FDA request, or by FDA order
under FDA’s mandatory recall authority. Recalls
are discussed in detail later in this chapter.
Enforcement Actions
Product Seizure
An action intended to remove a violative product
from commercial distribution. FDA initiates the
seizure process by filing a complaint to the US
court where the product is located. A US Marshall
as directed by the court seizes the products where
they are found until the issue is resolved.
Injunction
An order by the court that requires an individ-
ual or firm to halt the continued production or
distribution of a violative product until the indi-
vidual or firm complies with FDA regulations.
Criminal Prosecutions: An action taken
by FDA’s Office of Criminal Investigation17
to conduct criminal investigations against the
individual or firm responsible for illegal activities
involving an FDA-regulated product. They also
are responsible for arresting and bringing them
to the US Department of Justice for prosecu-
tion. Criminal prosecution is recommended for
products that are in violation of Section 301 of
the FD&C Act. 19
There are two types of criminal prosecutions
under Section 301 of the FD&C Act:
• Misdemeanor convictions: These types of
convictions do not require any evidence for
the violation of the FD&C Act. It can result
in fines and/or imprisonment up to one year.
• Felony convictions: It is applicable in
the case of a second violation or intent to
defraud or mislead. It can result in fines and/
or imprisonment for up to three years.
Postmarket surveillance studies are available
on the FDA database (https://www.accessdata.
fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm,)
which is updated on the fifth of every month.
Furthermore, protocols and final study reports
can be requested from FDA under the Freedom
of Information Act (FOIA).20