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510(k) Refuse to Accept (RTA) Process Guidance and Checklist Updates Office of Device Evaluation September 25, 2015Marjorie Schulman, Director 510(k) Program Marjorie. Schulman FDA.HHS.gov Office

How to fill out 510k refuse to accept

How to Fill Out 510(k) Refuse to Accept:

1. Gather all the necessary information and documentation required for filing a 510(k) Refuse to Accept (RTA) application.
2. Start by carefully reviewing the FDA's Refuse to Accept Policy for 510(k)s to understand the specific requirements and criteria they will evaluate your application against.
3. Fill out all the required sections of the 510(k) RTA application form accurately and thoroughly. Provide all the necessary details about the medical device, its intended use, and any predicate devices that it relies upon.
4. Prepare the appropriate supporting documentation, such as device descriptions, labeling, safety and efficacy data, risk analyses, manufacturing information, and any clinical trial information if applicable.
5. Ensure that all the necessary user fees are paid and submit your completed 510(k) RTA application to the FDA within the designated submission period.
6. After submission, closely monitor the progress of your application through the FDA's review process and promptly respond to any requests for additional information or clarifications.
7. If your application is accepted, it will proceed to the substantive review stage. If it is refused, the FDA will provide you with a detailed explanation indicating the deficiencies in your application that need to be addressed before resubmission.

Who Needs 510(k) Refuse to Accept:

1. Medical device manufacturers planning to introduce a new medical device to the U.S. market that requires clearance from the FDA must submit a 510(k) application.
2. The 510(k) Refuse to Accept process specifically applies to those manufacturers whose initial submissions are found to be incomplete or do not meet the FDA's acceptance criteria.
3. Therefore, any manufacturer whose 510(k) application has been refused to accept by the FDA needs to follow the 510(k) Refuse to Accept procedure to address the deficiencies and resubmit their application for further review and evaluation.

For pdfFiller’s FAQs

What is 510k refuse to accept?

510k refuse to accept is when the FDA refuses to accept a premarket notification submission (510k) for review because it does not meet the necessary requirements or contains deficiencies.

Who is required to file 510k refuse to accept?

Any company seeking to market a medical device in the United States that is not exempt from the premarket notification requirements must file a 510k submission.

How to fill out 510k refuse to accept?

To fill out a 510k refuse to accept submission, companies must provide detailed information about the device, its intended use, technological characteristics, and any testing or clinical data to support its safety and effectiveness.

What is the purpose of 510k refuse to accept?

The purpose of 510k refuse to accept is to ensure that medical devices marketed in the United States are safe and effective for their intended use by reviewing the submitted information and determining if the device meets the regulatory requirements.

What information must be reported on 510k refuse to accept?

The information reported on a 510k refuse to accept includes details about the device, its intended use, design and performance characteristics, materials, labeling, and any testing or clinical data supporting its safety and effectiveness.

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