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A premarket notification summary for the GE Discovery IGS 730, detailing device specifications, intended uses, regulatory compliance, and substantial equivalence determination for marketing.

How to fill out 510k premarket notification submission

How to fill out 510(k) Premarket Notification Submission

1. Determine if your device is substantially equivalent to a legally marketed device.
2. Gather necessary information including device description, indications for use, and performance testing data.
3. Complete Form FDA 3514 to provide details about the device and submit any required fees.
4. Prepare a summary of the device's technological characteristics and how they compare to the predicate device.
5. Provide safety and effectiveness information, including clinical data if applicable.
6. Compile labeling information that complies with FDA regulations.
7. Submit the complete 510(k) application to the FDA electronically or by mail.
8. Respond promptly to any inquiries from the FDA during their review process.

Who needs 510(k) Premarket Notification Submission?

1. Manufacturers of medical devices that are not exempt from premarket notification requirements under the FDA.
2. Companies looking to market devices that are considered substantially equivalent to existing, legally marketed devices.

People Also Ask about

What is an exemption from the 510K premarket notification requirements?

Most class I and class II devices are exempt from 510(k) requirements. Devices that may be 510(k) exempt include: Preamendment devices (devices legally marketed in the US prior to May 28, 1976) Class I devices specifically exempted by FDA or classified as class I under section 513 (with certain exceptions)

When to submit a 510 K premarket notification?

Manufacturers are required to submit a new 510(k) when a change (or changes) exceeds the 21 CFR 807.81(a)(3) threshold, “could significantly affect the safety or effectiveness of the device,” or constitutes a “major change or modification in the intended use of the device.” This significant effect could be positive or

What is the difference between premarket notification and 510K?

Your 510(k) submission should: Demonstrate your medical device is 'substantially equivalent' to a predicate already on the market. House detailed technical, safety and performance device/test information to show your device is safe and effective. Prove you have a robust medical device quality and risk management system.

What are the three types of 510K?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

What is the difference between 510K and premarket approval?

A PMA is more in-depth than a 510k - it is used to prove that a new device is safe and effective for the end user and typically requires clinical trials with human participants along with laboratory testing.

What is a premarket notification?

The premarket notification process is a regulatory control that is a component of general controls, guides medical device classification, and informs applicants and the FDA in the determination of substantial equivalence for new devices (FDA, 2014b).

How to prepare a 510 K submission?

Most class I and class II devices are exempt from 510(k) requirements. Devices that may be 510(k) exempt include: Preamendment devices (devices legally marketed in the US prior to May 28, 1976) Class I devices specifically exempted by FDA or classified as class I under section 513 (with certain exceptions)

For pdfFiller’s FAQs

What is 510(k) Premarket Notification Submission?

The 510(k) Premarket Notification Submission is a regulatory pathway for medical device manufacturers to demonstrate that their device is safe and effective by showing substantial equivalence to a legally marketed device.

Who is required to file 510(k) Premarket Notification Submission?

Manufacturers of medical devices that are considered Class II or some Class I devices that are not exempt from premarket notification are required to file a 510(k) Premarket Notification Submission.

How to fill out 510(k) Premarket Notification Submission?

To fill out a 510(k) submission, manufacturers must gather information about the device, including its intended use, technological characteristics, and evidence of substantial equivalence to a predicate device. They must also complete the required forms, provide a comprehensive description of the device, and submit any necessary supporting data.

What is the purpose of 510(k) Premarket Notification Submission?

The purpose of the 510(k) Premarket Notification Submission is to obtain FDA clearance to market a medical device by demonstrating that it is safe and effective for its intended use and is substantially equivalent to an already marketed device.

What information must be reported on 510(k) Premarket Notification Submission?

The information that must be reported includes the device name, proposed labeling, intended use, description of the device, summary of performance testing, comparisons to predicate devices, and any other relevant information that supports substantial equivalence.