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/OT, GE Medical Systems Information Technologies 1 5 20085.0510(k) Summary5.1Applicant and Contact Information 5.1.1 Submitter/Manufacturing Information GE Medical Systems Information Technologies 9900

How to fill out traditional 510kpremarket notification

How to fill out traditional 510kpremarket notification

1. Step 1: Determine whether your device requires a 510(k) premarket notification.
2. Step 2: Obtain and familiarize yourself with the appropriate guidance documents for the submission.
3. Step 3: Prepare the 510(k) submission including a cover letter, completed FDA Form 3514, device description, indications for use, substantial equivalence discussion, etc.
4. Step 4: Compile all necessary documentation including labeling, labeling review and summary, performance testing data, biocompatibility testing data, etc.
5. Step 5: Submit the 510(k) premarket notification to the FDA and pay the associated fee.
6. Step 6: Respond to any requests for additional information or clarification from the FDA in a timely manner.

Who needs traditional 510kpremarket notification?

1. Manufacturers of medical devices that are not exempt from 510(k) requirements and are introducing a new device, modifying an existing device, or re-introducing a device that was previously cleared by the FDA.

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What is traditional 510kpremarket notification?

Traditional 510(k) premarket notification is a submission made to the FDA to demonstrate that the medical device to be marketed is at least as safe and effective as a legally marketed device (predicate device).

Who is required to file traditional 510kpremarket notification?

Manufacturers of medical devices are required to file traditional 510(k) premarket notification.

How to fill out traditional 510kpremarket notification?

To fill out traditional 510(k) premarket notification, the manufacturer must provide information on the medical device, its intended use, a comparison to a predicate device, and any testing or clinical data.

What is the purpose of traditional 510kpremarket notification?

The purpose of traditional 510(k) premarket notification is to demonstrate to the FDA that the new medical device is substantially equivalent to a legally marketed device (predicate device) and does not raise new questions of safety and effectiveness.

What information must be reported on traditional 510kpremarket notification?

Information such as device description, intended use, performance data, biocompatibility, software, sterility, and labeling must be reported on traditional 510(k) premarket notification.