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This document provides a summary of the information related to the 510(k) premarket notification submission for GE Healthcare's Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems, detailing

How to fill out 510k premarket notification submission

How to fill out 510(k) Premarket Notification Submission

1. Identify the device classification and any applicable predicate devices.
2. Gather necessary information about the device, including design, materials, intended use, and technological characteristics.
3. Prepare a summary that compares your device to the predicate device addressing safety and effectiveness.
4. Compile supporting documentation including labeling, testing data, and preclinical studies.
5. Complete the 510(k) submission form with accurate and detailed information.
6. Organize the submission according to the FDA guidelines, ensuring all required sections are included.
7. Submit the 510(k) electronically or via paper to the FDA along with the applicable fees.
8. Respond promptly to any FDA inquiries or additional information requests during the review process.

Who needs 510(k) Premarket Notification Submission?

1. Manufacturers of medical devices that are not exempt from premarket notification requirements and intend to market their devices in the United States.

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 submission made to the FDA to demonstrate that a medical device is safe and effective and is substantially equivalent to a legally marketed device.

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

Manufacturers of medical devices that intend to market a device in the United States and that do not fall under the exemption categories 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) Premarket Notification Submission, the applicant must complete the necessary forms, provide detailed information about the device, its intended use, and performance testing, and submit it to the FDA electronically as per the guidelines provided.

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

The purpose of the 510(k) Premarket Notification Submission is to establish that a new medical device is at least as safe and effective as an already approved device, thereby allowing its entry into the market.

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

The information that must be reported includes the device name, intended use, device description, labeling, performance data, and any other relevant information that demonstrates substantial equivalence to a predicate device.