This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP’s.
Preamendment
Status
For purposes of documenting preamendment status in regard to intended use and
commercial distribution, information provided must be adequate to document that
the firm's preamendment device was labeled, promoted, and distributed in interstate
commerce for a specific intended use. Please keep in mind that if this preamendment
information is used to support a premarket notification (510(k)), then the specific
intended use statements requested below should be the same as that proposed for
the subject 510(k) device for which substantial equivalence is being sought. The
Office of Device Evaluation (ODE) will provide input as to whether the specificity
of the intended use statements are adequate if a 510(k) is involved.
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.
- 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.
- 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
- a 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.
- 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.
Any questions relating to preamendment status should be addressed to the Office
of Compliance at 240-276-0141.