Get the free 510k form - cbgnetwork

DEPARTMENT OF HEALTH HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring MD 20993 TRANSMITTED BY FACSIMILE Fadwa Almanakly Pharm.D. Associate Director Advertising and Promotions Bayer HealthCare Pharmaceuticals Inc. 6 West Belt Wayne NJ 07470-6806 RE NDA 21-225 -releasing intrauterine system MACMIS 18166 Dear Dr.

How to fill out 510k form - cbgnetwork

How to fill out 510k form:

1. Start by accessing the official FDA website and downloading the 510k form.
2. Carefully read the instructions provided on the form to have a clear understanding of the requirements.
3. Begin filling out the form by entering your company's name, contact information, and the device name and description.
4. Provide detailed information about the device, including its intended use, technological characteristics, and how it compares to similar devices already on the market.
5. If applicable, list any modifications or changes made to the device and include relevant documentation supporting those changes.
6. Include information about any clinical or non-clinical testing conducted, including study protocols, results, and references.
7. Provide a detailed summary of the device's safety and effectiveness, along with any potential risks associated with its use.
8. Include a list of all components, accessories, and labeling materials associated with the device.
9. Complete any additional sections of the form related to the specific device being submitted.
10. Review the form thoroughly to ensure all sections are completed accurately and all necessary supporting documents are included.
11. Sign the form, indicating your acceptance of the information provided and your responsibility for its accuracy.

Who needs a 510k form:

1. Manufacturers or distributors who want to introduce a new medical device into the United States market.
2. Companies seeking clearance for certain modifications or changes to existing medical devices.
3. Any individuals or organizations involved in the production, importation, or distribution of medical devices that are subject to regulation by the U.S. Food and Drug Administration (FDA).

For pdfFiller’s FAQs

What is 510k form?

The 510k form is a submission made to the U.S. Food and Drug Administration (FDA) for clearance to market a medical device.

Who is required to file 510k form?

All manufacturers intending to market a medical device in the United States are required to file a 510k form.

How to fill out 510k form?

The 510k form can be filled out online through the FDA's Electronic Submission Gateway (ESG). The form requires detailed information about the device's safety, efficacy, and intended use.

What is the purpose of 510k form?

The purpose of the 510k form is to demonstrate that a medical device is substantially equivalent to a device already on the market, or to provide evidence of the device's safety and effectiveness.

What information must be reported on 510k form?

The 510k form requires information about the device's design, materials, manufacturing processes, intended use, and any clinical data or testing conducted.

When is the deadline to file 510k form in 2023?

The specific deadline for filing the 510k form in 2023 can vary based on the device and other factors. It is recommended to consult the FDA's guidelines or contact them directly for the accurate deadline.

What is the penalty for the late filing of 510k form?

The penalty for the late filing of a 510k form can include delays in marketing the device, potential fines, and possible regulatory actions by the FDA.

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