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Compliance In Focus
Posted by Shawn Kennedy on Thu, Nov 12, 2015

What is the FDA Form 3674?

Recently, while on a monitoring visit for a physician sponsored IDE study in which IMARC was concurrentlyWhat_is_the_FDA_Form_3674 conducting a clinical audit, I was caught off guard by the question “do you know what the FDA Form 3674 is?”  I thought I had spent a good deal of my professional career working in the clinical research industry, I try my best to be a diligent student of the regulations and GCP guidelines, and even have tested my wits by passing the SOCRA certified clinical research professional exam.  However, I was stumped when it came to this mysterious form, albeit somewhat relieved that my co-monitor and the auditor that asked me were equally baffled by what it was.  At our auditor’s good suggestion, we took to finding the answer.  That night, she emailed FDAs FDAs gcp.questions@fda.hhs.gov for their input.  This is really a fantastic tool in and of itself if you have not utilized it, someone from FDA will respond to your questions regarding good clinical practice in the field of clinical research.

The response she received was quite informative.  It indicated that the FDA Form 3674 went into effect on 26 December 2007 and it pertains to certification that must accompany drug, biologic product, and device submissions indicating that the correct information had been previously submitted to the clinical trials databank at clinicaltrials.gov.  Our initial response was: “have we been properly checking to ensure the sites that we audit and monitor have been preparing and submitting this form?”  So we dug a little deeper into the other portion of the response that was received from FDA, an FDA Guidance document about the form 3674, titled “Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007.”  It was here that we gleaned the answer we were looking for.  As it turns out, whether or not the Form 3674 is required to be included in a submission depends on a few different things: the type of submission, and the type of investigational product.

To speak to the first variable, when talking about the type of submission the requirement to submit this form is invoked when you submit a marketing application, not an NDA or IDE application to conduct an investigation.  The second variable brings in to play the type of investigational product.  For IMARC, it was important to determine if and when Form 3674 is required for device studies.  The guidance notes that it would be required when submitting a marketing application for a 510(k) or Humanitarian Use Device only, again not an IDE.  After learning this, we were all relieved to know that none of us had heard of the form because the physician sponsored IDE studies that we have audited and monitored do not fulfill these criteria as they have no intention of submitting a marketing application.  And should they ever change their mind and submit the data to the FDA in support of a 510(k), they could complete the Form 3674 at that time.

As we know that some of our audience may not work exclusively in the device arena, here is a summary from the guidance document that lists out which applications/submissions (including resubmissions) that require the form:

  • IND
  • New Clinical Protocol Submitted to an IND
  • NDA
  • Efficacy Supplement to an Approved NDA
  • BLA
  • Efficacy Supplement
  • ANDA
  • PMA
  • PMA Panel Track Supplement
  • HDE
  • 510(k) that refers to, relates to, or includes information on a clinical trial

Do you have any experience with the FDA form 3674?


photo credit: Question Mark via photopin (license)

Topics: 510(k) Program, Clinical Auditing, FDA, Form 3674


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