medisourceasia.com logo

Ask the Expert

 

 


Home

About 
medisourceasia

Magazine
Industry News
Global Trends
Events Calendar
Web Links

Web Gallery

Advertising  Info

Contact

510 submissions for the product has been on the market prior to May 28 1976
Just read your articles on 510 submissions Perhaps you can answer this question. You mention that a 510(k) need not be submitted if the product has been on the market prior to May 28 1976 . How would you go about proving this to the FDA?
 

Advertisement

 

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 devices 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 FDAs 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.

  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
     

    * 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.

 

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.

  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.

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.

Back To Top