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U.S. Department of Health and Human Services

Medical Devices

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Preamendment Status

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.

  1. 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.

  1. The submitter is not able to provide any of the information described in item A above.
    1. 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.
    2. 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.

  2. 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.
    1. Provide all partial documentation as described in item A above.
    2. Provide the complete/partial affidavit from a current or former employee as described in item B(1) above.
    3. 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.

Preamendment device determination requests should be submitted using form FDA 3752.

Any questions relating to preamendment status should be addressed to the Office of Compliance at 301-796-5506.