FDA 3602 2014 free printable template

Gov An agency may not conduct or sponsor and a person is not required to respond to a Instructions for Form FDA 3602 for FY 2015 FY 2015 MDUFA Small Business Qualification and Certification You should complete and submit Form FDA 3602 for FY 2015 FY 2015 MDUFA Small Business Qualification and Certification if you wish to be eligible for reduced or waived fees for medical device submissions you make during FY 2015 submissions received by FDA from October 1 2014 through September 30 2015. 1001...

How to fill out FDA 3602

How to fill out FDA 3602

1. Obtain a copy of the FDA Form 3602.
2. Fill in your contact information at the top of the form.
3. Indicate the type of application being submitted.
4. Provide a detailed description of the product or service.
5. Include any applicable regulatory history and previous submissions.
6. List any commitment made to the FDA, including timelines and conditions.
7. Review the form for completeness and accuracy before submission.
8. Submit the completed form to the designated FDA office.

Who needs FDA 3602?

1. Businesses or individuals planning to submit a new FDA application.
2. Manufacturers looking for product approval.
3. Applicants seeking pre-market approval for biologics or drugs.
4. Anyone involved in regulatory compliance related to FDA products.

People Also Ask about

Do small businesses need to be FDA approved?

Facilities that manufacture, process, pack, or hold food that is intended for human or animal consumption in the United States must register with FDA before beginning these activities.

How do I contact the FDA for a small business?

Please contact the nearest ORA district office listed in the ORA Directory or contact FDA Headquarters at 1-888-INFO-FDA (1-888-463-6332 ).

What is the OMB number 0910 0508?

OMB Control Number 0910-0508—Extension This information collection helps support implementation of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250) and FDA's Medical Device User Fee program.

What is the phone number for the FDA small business?

Please contact the nearest ORA district office listed in the ORA Directory or contact FDA Headquarters at 1-888-INFO-FDA (1-888-463-6332 ).

What is FDA small business?

Small Business Defined. Defined by statues as having no more than 500 employees, including affiliates. An affiliate is a business entity that has a relationship with a second business entity in which one controls, or has the power to control, the other, or a third party controls, or has the power to control, both.

For pdfFiller’s FAQs

How do I edit FDA 3602 online?

With pdfFiller, you may not only alter the content but also rearrange the pages. Upload your FDA 3602 and modify it with a few clicks. The editor lets you add photos, sticky notes, text boxes, and more to PDFs.

Can I create an electronic signature for the FDA 3602 in Chrome?

As a PDF editor and form builder, pdfFiller has a lot of features. It also has a powerful e-signature tool that you can add to your Chrome browser. With our extension, you can type, draw, or take a picture of your signature with your webcam to make your legally-binding eSignature. Choose how you want to sign your FDA 3602 and you'll be done in minutes.

How do I fill out the FDA 3602 form on my smartphone?

You can easily create and fill out legal forms with the help of the pdfFiller mobile app. Complete and sign FDA 3602 and other documents on your mobile device using the application. Visit pdfFiller’s webpage to learn more about the functionalities of the PDF editor.

What is FDA 3602?

FDA 3602 is a form used for the submission of reports related to the fees that certain entities must pay to the FDA, particularly for the approval and maintenance of drugs and biologics.

Who is required to file FDA 3602?

Entities involved in the pharmaceutical and biotechnology industries, particularly those submitting applications for new drugs or biologics that are subject to FDA user fees, are required to file FDA 3602.

How to fill out FDA 3602?

To fill out FDA 3602, entities should follow the explicit instructions provided by the FDA, which include sections on identifying the entity, the type of submission, and the associated fees. Accurate and complete information is necessary to ensure compliance.

What is the purpose of FDA 3602?

The purpose of FDA 3602 is to facilitate the collection of user fees for new drug applications and biologics license applications, ensuring that the FDA has the necessary resources to effectively evaluate and approve these submissions.

What information must be reported on FDA 3602?

FDA 3602 requires reporting of information such as the applicant's details, submission type, fee category, and payment information to properly process the fees associated with the application or submission.