Get the free GEHC Special 510k Premarket Notification Template - accessdata fda

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66G609 Silver Spring, MD 209930002 December 3, 2014, GE

How to fill out gehc special 510k premarket

How to fill out GEHC special 510k premarket:

1. Begin by carefully reading and understanding the instructions provided by GEHC regarding the special 510k premarket application process. Familiarize yourself with the specific requirements and documentation needed for this particular application.
2. Gather all relevant information and documents required for the application. This may include details about your device, its intended use, its technological characteristics, any modifications made, and supporting data or studies.
3. Fill out the application form provided by GEHC, ensuring that each section is completed accurately and thoroughly. Pay particular attention to any fields that require technical specifications, safety data, performance data, and clinical evaluations if applicable.
4. Provide a detailed description of the intended use of the device, including any indications for use, patient population, and potential benefits it offers.
5. Include any changes or modifications made to the device since its initial clearance or approval, and explain the reasons for these modifications.
6. If applicable, provide a comprehensive risk analysis of the device, identifying potential hazards or risks associated with its use and outlining the steps taken to mitigate them.
7. Include any relevant performance testing data or laboratory studies, demonstrating how the device meets the necessary performance criteria or safety standards.
8. If necessary, include any clinical data or studies supporting the safety and effectiveness of the device, ensuring they comply with applicable regulations and guidelines.
9. Clearly outline any labeling or instructions for use that will accompany the device, ensuring they are accurate, comprehensive, and in compliance with applicable regulations.

Who needs GEHC special 510k premarket?

1. Manufacturers or sponsors of medical devices seeking clearance or approval from the U.S. Food and Drug Administration (FDA) for certain modifications or changes to a previously cleared or approved device may need to apply for a GEHC special 510k premarket.
2. This applies to medical devices that have been previously cleared through the FDA's 510(k) pathway and have undergone changes that could significantly affect its safety or effectiveness.
3. The GEHC special 510k premarket is designed to ensure that these modifications or changes do not pose an unreasonable risk to patients and that the device continues to meet the necessary regulatory standards.

It is important to note that specific requirements and eligibility criteria may vary, so it is recommended to consult the guidelines and instructions provided by GEHC or the FDA for accurate and up-to-date information.

For pdfFiller’s FAQs

What is gehc special 510k premarket?

GEHC special 510k premarket is a type of submission to the FDA for medical devices that may pose a moderate risk. It allows for a faster review process compared to a traditional 510k premarket submission.

Who is required to file gehc special 510k premarket?

Manufacturers of medical devices that fall under the moderate risk category are required to file a GEHC special 510k premarket.

How to fill out gehc special 510k premarket?

To fill out a GEHC special 510k premarket submission, manufacturers need to provide detailed information about the device, its intended use, its design, performance data, and any similarities to other devices on the market.

What is the purpose of gehc special 510k premarket?

The purpose of GEHC special 510k premarket is to demonstrate that a medical device is substantially equivalent to a device that is already legally marketed in the US, while also addressing any potential risks associated with the device.

What information must be reported on gehc special 510k premarket?

The information that must be reported on a GEHC special 510k premarket submission includes a detailed description of the device, its intended use, its technological characteristics, performance data, and any clinical data supporting its safety and efficacy.

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