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Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals
Misbranding |
Section 502 of the FFDCA contains provisions on misbranding and false or misleading
labeling. A device is misbranded if:
Note: Previously, it was considered misbranding to
have the premarket approval application (PMA) number on the device labeling. The FDA Modernization Act of 1997 (FDAMA) repealed the restriction in Section 301(l) of the Federal Food, Drug and Cosmetic (FFD&C) Act, which prohibited reference to FDA approval in the labeling or advertising of medical devices that have an approved PMA or IDE.
False or Misleading Labeling |
Section 502(a) declares that a drug or device is misbranded if its labeling proves
false or misleading in any particular. This phrase "false or misleading" is not
confined in meaning to untrue, forged, fraudulent, or deceptive. In fact, the word,
statement, or illustration may be true in the strict sense of the word; however, the
labeling can be deemed by the FDA to be in violation of the law if it proves deceptive to
the customer. It is not a necessary condition that the labeling should be flatly and
baldly false; the work "misleading" in the Act means that labeling is deceptive
if it is such as to create or lead to a false impression in the mind of the reader. A
"false impression" may result not only from a false deceptive statement, but may
also be instilled in the mind of the purchaser by ambiguity or misdirection. It may also
be caused by failure to inform the consumer of facts that are relevant to those statements
actually made. In other words, the label that remains silent as to certain consequences
may be as deceptive as the label that contains extravagant claims.
A device can be misbranded by making reference to a medical device registration
number assigned by FDA in response to a firm's filing requirements under the
FFDCA. Section
807.39 of 21 CFR, misbranding by reference to establishment registration
or registration number states that the assigned numbers do not constitute official
FDA approval of the device.
Examples of false labeling include:
Examples of misleading labeling include:
Examples of other objectionable labeling practices include:
Permissible Promotional Labeling |
The Modernization Act sets forth conditions under which firms may promote devices
that have an approved IDE or PMA. Manufacturers may disseminate written information
concerning the safety, effectiveness, or benefit of a use not described in a
devices approved labeling to health care practitioners, pharmacy benefit
managers, health insurance issuers, group health plans, or Federal or State
agencies provided the following requirements are satisfied:
1) unabridged reprints or copies of peer-reviewed, scientifically sound
articles published in scientific or medical journals about clinical investigations
involving the device; or
2) reference publications that include information about clinical investigations.
1) that the use is not approved or cleared by FDA;
2) if applicable, that the information is being disseminated at the expense
of the manufacturer;
3) if applicable, the names of any authors of the information who are
employees or consultants to the manufacturer or have received compensation
or have a financial interest in the manufacturer;
4) the official labeling and all updates;
5) if applicable, a statement that there are products or treatments that
have been approved or cleared for the use that is the subject of the information;
and
6) the identification of any person that has provided funding for the
study related to the new use.
if FDA determines that the manufacturer fails to provide data,
analyses or other written matter that is objective and balanced, FDA may
require the manufacturer to disseminate additional objective and scientifically
sound information that pertains to the safety and effectiveness of the use
that is the subject of the information and an objective statement of FDA
that bears on the safety or effectiveness of the new use.
And:
the manufacturer has submitted a supplemental application
for such use;
Or:
in the case of a completed study, the manufacturer submits
to FDA an application containing a certification that the studies needed
for a supplemental application for the new use are completed and the supplemental
application will be submitted within 6 months after the initial dissemination
of information on the new use;
Or:
in the case of a planned study, the manufacturer submits an
application to FDA containing a proposed protocol and schedule for conducting
the studies needed for the supplemental application for the new use and
a certification that the supplemental application will be submitted not
later than 36 months after the initial dissemination of information on the
new use;
Or:
Information on other Labeling Issues
Updated September 2, 2008
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