|
A medical device that was legally in
commercial distribution in the United States of America before May 28, 1976
is called a preamendment device. (That was the date that the Medical Device
Amendments became U.S. law). A preamendment device would not have a 510(k)
Number since they were grandfathered for 510(k) review.
Sometimes, companies searching for a predicate
device for their medical device consider using a preamendment device as the
predicate. Generally, this is not a good idea since in the last 30 years
there have been such dramatic changes in medical device technology. It is
also hard to demonstrate that you have a legitimate preamendment device. For
that to be true, the device’s technology must not have been changed
significantly over the years and there must not be any published regulations
for it that require submission of a premarket approval (PMA) application.
The preamendment device must have the same intended use as the product that
you wish to market if you are to use it as a predicate device.
So, how can you demonstrate to FDA’s
satisfaction that the proposed preamendment device was labeled, promoted and
distributed in intestate commerce for the same intended use as your proposed
product? Here is what the FDA advises:
“FDA believes that submitters should be able
to meet one of the following three scenarios (A, B, or C) in order to prove
preamendment status of a device for a specific use. Below each italicized
description of the scenario is the list of information required for that
particular scenario.
A.
The submitter is able to provide copies of
documents that verify that the device was placed into interstate commerce
(for other than research uses or as part of a plant-to-plant transfer) and
was actually labeled and promoted for a specific intended use.
Provide dated copies of any available firm's advertisements, catalog
pages, promotional material, journal article, manufacturing documents, and
shipping documents (e.g., invoices, bills of lading, receipts, etc.). FDA
may also consider other pieces of information to address this item.
Nevertheless, the information provided (individually or collectively) must
prove that there was interstate commerce of the device and that the device
was labeled and promoted for a specific intended use prior to May 28, 1976.
Copies of any supporting information (e.g., journal article) must be
provided, not just referenced. In addition, any supporting information must
reflect the device was not used as part of any research study or for
investigational use.
B
The submitter is not able to provide any of
the information described in item A above.
-
Provide an affidavit from a current or former
employee of the firm that distributed the device who is, or was, in a
position to be aware of the labeling and promotional information used for
the device and to attest that the device was distributed prior to May 28,
1976. This affidavit must include the following:
* a statement explaining why any invoices or
shipping records of pre-May 28, 1976 distribution are not available;
* detailed information relating to his/her
position and how that placed he/she in a position to be aware of the
preamendment labeling and promotion of the device;
* a statement that the device was not used
as part of any research study or for investigational use prior to May 28,
1976;
* a statement, with any available supporting
documentation, of the specific intended uses for which the device was
labeled and promoted prior to May 28, 1976. Actual copies of any
supporting information (e.g., journal article) must be provided, not just
referenced. Any supporting information must not reflect the use of the
device as part of any research study or for investigational use prior to
May 28, 1976; and
* statement of his/her financial interest in
the device or firm.
-
Provide an affidavit from a credible person
who used the device prior to May 28, 1976. The affidavit must include the
following:
* a statement that the user has personal knowledge that the device
entered interstate commerce prior to May 28, 1976;
* the name of the source and the state from which the device was
shipped;
* a statement that the device was not received as part of any research study
or for investigational use prior to May 28, 1976;
* statement, with any available supporting documentation, of the specific
intended uses for which the device was labeled and promoted prior to May 28,
1976. Actual copies of any supporting information (e.g., journal article)
must be provided, not just referenced; and
* a statement of his/her financial interest in the device or firm.
Note: If it is not possible to obtain the
affidavit for item B (1) above, then provide an affidavit documenting your
efforts to obtain one, and provide affidavits from two credible users.
C
The submitter is able to provide only a
portion of the information necessary to address item A above. In this case,
we may accept partial documentation from each of items A and B (1 and 2)
above. However, the submitter should attempt to address each item as
complete as possible. Nevertheless, the collective documentation must, at
minimum, address the key elements noted below.
-
Provide all partial documentation as described
in item A above.
-
Provide the complete/partial affidavit from a
current or former employee as described in item B (1) above.
-
Provide the complete/partial affidavit(s) from
a credible user(s) as described in item B (2) above.
Note: The key elements that must be addressed by the collective pool of
documentation are:
* evidence of interstate commerce (for other
than research uses or as part of a plant-to-plant transfer) prior to May 28,
1976;
* evidence of the specific intended use for
which the device was labeled/promoted prior to May 28, 1976; and
* any affiant's financial interest in the
device or firm.
All affidavits supplied must be notarized and include a statement
concerning one's financial interest in the device or firm. Affidavits
from individuals residing in other countries may be taken into consideration
when accompanied with affidavits signed by persons residing in the U.S.”
As you can see, documentation of the preamendment status of a product is not
always easy. I avoid the problem of documentation of preamendment status by
avoiding such products, if possible. I would rather look up the
classification code for the product of interest and then identify by
reviewing published summaries that 510(k)s would make good predicate
devices. I then try to get copies of the redacted 510(k)s, usually from
commercial sources.
I hope that your questions have been answered.
|
