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LEGALLY
MARKETED DEVICES
A
legally marketed device can be:
-
a device that was
legally marketed prior to May 28, 1976. That is the date
that the law called the Medical Device Amendments of 1976 was
passed. A device legally marketed before passage of this law
is called a “preamendments device”
-
a device which
has been reclassified from Class III to Class II or I (See
Archives)
-
a device which
has been found to be substantially equivalent to such a device
through the 510(k) process. This is the most common
situation today.
-
a low risk Class
III device that has no predicate that has gone through the
Evaluation of Automatic Class III Designation process. This
is a new way to reclassify statutorily classified Class III
products that pose low risks. It arose from passage of a law
called The Food and Drug Administration Modernization Act of 1997.
More information about it can be found at http://www.fda.gov/cdrh/modact/classiii.html
SUBSTANTIAL
EQUIVALENCE (SE)
A
device is SE if, in comparison to a predicate device it:
-
has the same
intended use as the predicate device; and
-
has the same
technological characteristics as the predicate device; or
-
has different
technological characteristics that do not raise new questions of
safety and effectiveness and the sponsor demonstrates that the
device is as safe and effective as the legally marketed device.
It is important to
understand that the new device and the predicate device need not be
identical. One normally prepares a comparison table
showing the how both devices compare with respect to such factors as
intended use, safety, effectiveness, design, energy used or delivered,
materials, performance, labeling, biocompatibility and
standards. We will go into more detail later about how we show
SE. Showing SE to FDA’s satisfaction is of crucial importance
to the applicant since, once the FDA determines that a device is SE to
a predicate device, then it can be marketed in the United States.
WHO SUBMITS A
510(K)
Domestic
Manufacturers Introducing A Device To The U.S. Market
WHO MUST SUBMIT:
*Finished device
manufacturers that assemble a device according to their own
specifications for market in the U.S.
WHO DOES NOT
SUBMIT:
*Manufacturers
of device unless such components are promoted for sale to an end user
as replacement parts.
*Contract
manufacturers that assemble devices according to someone else's
specifications.
Specification Developers
Introducing a Device to the U.S. Market
A specification developer develops specifications for a finished
device but has it manufactured by a contract manufacturer. The
specification developer rather than the contract manufacturer submits
the 510(k). The FDA considers specification developers to be
almost the same as manufacturers.
Repackers or Relabelers Who
Make Labeling Changes, or Whose Operations Significantly Affect The
Device.
Repackagers or relabelers are not required to submit a 510(k) unless
they significantly change the labeling or otherwise affect any
condition of the device. This includes, for example, significant
changes in labeling, manuals, addition or deletion of warnings or
contraindications and if the packaging operation could alter the
condition of the device.
Foreign Manufacturers/Exporters
or U.S. Representatives Of Foreign Manufacturers/Exporters Introducing
a Device to the U.S. Market.
Next time, we will
continue our exploration of the 510(k).
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NOTE TO READERS:
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Please
understand that in order to make FDA requirements more
understandable, I do simplify some of the language and omit some
details. You must rely on the actual regulations-not any
of my columns to ensure you meet FDA requirements. |
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