FORM FDA 3674 Certification of Compliance Under 42 U S C 282(j)(5)(B), with Requirements of Clinical-2025

See details

4.3 out of 5

20 votes

The document is a certification form (Form FDA 3674) required by the Food and Drug Administration (FDA) for compliance with the ClinicalTrials.gov Data Bank under U.S. law. It must accompany various types of applications or submissions related to drugs, biologics, or medical devices. The form includes sections for sponsor information, product details, application type, and a certification statement regarding the applicability of clinical trial requirements. It outlines the responsibilities of the sponsor/applicant in relation to clinical trials referenced in their submission.

Here's how it works

01. Edit your fda 3674 form online

Type text, add images, blackout confidential details, add comments, highlights and more.

02. Sign it in a few clicks

Draw your signature, type it, upload its image, or use your mobile device as a signature pad.

03. Share your form with others

Send form 3674 via email, link, or fax. You can also download it, export it or print it out.

How to use or fill out FORM FDA 3674 Certification of Compliance Under 42 U.S.C. 282(j)(5)(B), with Requirements of Clinical

Ease of Setup

DocHub User Ratings on G2

Ease of Use

DocHub User Ratings on G2

Click ‘Get Form’ to open it in the editor.
Begin by entering the 'Name of Sponsor/Applicant/Submitter' in the designated field, ensuring it matches the application.
Input the 'Date of the Application/Submission' accurately to reflect when you submitted your application.
Fill in your complete address, including telephone and fax numbers, in sections 3 and 4.
For 'Product Information', provide all relevant names for drugs or devices as specified in section 5.
Select the type of application/submission from section 6 by checking the appropriate box.
If applicable, enter any previously assigned IND/NDA/BLA numbers in section 7.
In section 9, check one box that best describes your certification status regarding clinical trials.
If you checked Box C, list any National Clinical Trial (NCT) Numbers in section 10.
Complete sections for signer information and ensure all fields are filled before submitting.

Start using our platform today to easily fill out and submit your FORM FDA 3674 for free!

See more FORM FDA 3674 Certification of Compliance Under 42 U S C 282(j)(5)(B), with Requirements of Clinical versions

We've got more versions of the FORM FDA 3674 Certification of Compliance Under 42 U S C 282(j)(5)(B), with Requirements of Clinical form. Select the right FORM FDA 3674 Certification of Compliance Under 42 U S C 282(j)(5)(B), with Requirements of Clinical version from the list and start editing it straight away!

Versions	Form popularity	Fillable & printable
2024	4.3 Satisfied (26 Votes)
2023	4.3 Satisfied (20 Votes)
2019	4.6 Satisfied (55 Votes)
2012	4 Satisfied (22 Votes)

be ready to get more

Complete this form in 5 minutes or less

Get form

Got questions?

We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

What is the 3454 form for clinical research?

Form FDA 3454, or the Financial Certification or Disclosure Statement, is used to submit information regarding clinical investigators who participated in the clinical studies. If no clinical studies were performed, simply state: no clinical studies were performed to test this device.

What is a certificate of compliance FDA?

Certificate of Compliance (CoC): It attests that the product complies with applicable laws, regulations, or industry standards, ensuring safety, quality, and environmental sustainability.

What is the purpose of a certificate of compliance?

A certificate of compliance is a document that certifies that a product or system meets the requirements of a safety regulation or standard. It is typically used in shipping and logistics to ensure that products are safe for transport and meet the destination countrys requirements.

Do you need FDA approval for clinical trials?

All investigator-initiated clinical trials must register on ClinicalTrials.gov to comply with federal FDA requirements outlined in FDA 42 CFR 11 (Final Rule) and/or other federal agencies and departments policy or requirements. Studies that fall under multiple registration requirements only need to be registered once.

What does FDA compliance mean?

A compliance certification is a certification that proves someone understands and can perform a job in alignment with their professions regulations.

form fda 3674

42 u.s.c. § 282(j), section 402(j) of the public health service act FDA form 3674 download FDA form 3674 PDF FDA Forms FDA form 3455 FDA Form 3454 vs 3455 FDA 1572 Form PDF Form FDA 3674 instructions

What is the FDA form 3674 used for?

Though FDA Form 3674 has been required for nearly all data submitted to the FDA since December 2007, it is not nearly as well recognized. The form is a notification of compliance signifying that the trials have been correctly registered and documented on clinicaltrials.gov (CT.

What is the difference between a certificate of compliance and a COA?

A COC assures adherence to regulatory and safety norms, while a COA, often issued by external laboratories, offers detailed test results and analysis, underscoring the products quality and safety.