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This document serves as a 510(k) premarket notification for the AIDA V1.5 Diagnostic Ultrasound System GM-72P00A, detailing its intended use, device descriptions, regulatory classifications, and justification

How to fill out 510k premarket notification

How to fill out 510(k) Premarket Notification

1. Identify the device that you plan to submit and ensure it requires a 510(k) submission.
2. Determine the appropriate predicate device that your product is equivalent to, focusing on intended use and technological characteristics.
3. Gather all necessary information about your device, including descriptions, intended use, and manufacturing processes.
4. Conduct risk analysis to evaluate potential safety and effectiveness concerns.
5. Compile performance testing data that supports the safety and effectiveness of your device.
6. Prepare the 510(k) submission in compliance with FDA guidelines, ensuring all sections are complete and accurate.
7. Submit the 510(k) application to the FDA, including all required documents and fees.
8. Respond to any additional requests for information or clarification from the FDA during their review process.
9. Await feedback from the FDA regarding the decision on your 510(k) application.

Who needs 510(k) Premarket Notification?

1. Manufacturers intending to market a medical device that is not exempt from premarket notification.
2. Companies that are introducing a new device that is similar to a previously cleared device in terms of safety and effectiveness.
3. Business entities who are looking to modify an existing device that may change its intended use or technology.

People Also Ask about

What is a 510 K premarket notification?

Information from the Design Controls process is crucial. The FDA usually takes 30-90 days to process 510(k) submissions — however, the entire premarket notification process can take much longer. If accepted, the submission is listed in the database. Generally, Class II medical devices require a 510k submission.

What is the difference between premarket notification and 510k?

510(k) clearance is authorisation from the FDA to market a medium-risk medical device, while PMA (premarket approval) is required for more high-risk and novel products.

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 an exemption from the 510K premarket notification requirements?

The premarket notification 510(k) process requires a medical device manufacturer to 'notify' FDA 90 days before they propose to begin marketing a new or certain modified device. This notification submission allows FDA to determine whether a device is substantially equivalent to one or more predicate devices.

What is the pre market notification process?

The premarket notification 510(k) process requires a medical device manufacturer to 'notify' FDA 90 days before they propose to begin marketing a new or certain modified device. This notification submission allows FDA to determine whether a device is substantially equivalent to one or more predicate devices.

How long does it take for the 510 K determination in the case of traditional premarket notification?

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)

What is a section 510k premarket notification of intent?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

For pdfFiller’s FAQs

What is 510(k) Premarket Notification?

The 510(k) Premarket Notification is a submission made to the FDA to demonstrate that a medical device is safe and effective, and is substantially equivalent to a device already approved.

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

Manufacturers of medical devices that are not exempt from premarket review, or devices that are substantially equivalent to an existing marketed device, are required to file a 510(k) Premarket Notification.

How to fill out 510(k) Premarket Notification?

To fill out a 510(k), manufacturers must prepare a comprehensive document including device descriptions, intended use, substantial equivalence rationale, labeling, and performance testing data.

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

The purpose of the 510(k) Premarket Notification is to ensure that medical devices are safe and effective for their intended use before they are marketed in the United States.

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

The 510(k) Premarket Notification must report information such as the device name, manufacturer details, intended use, description of the device, comparisons to predicate devices, and any data from testing or clinical studies.