Get the free ORIGINAL, TRADITIONAL 510(K) NOTIFICATION - accessdata fda

This document provides a summary and notification regarding the 510(k) submission for Permobil's M300 and M400 powered wheelchairs, including details about their intended use, device specifications,

How to fill out original traditional 510k notification

How to fill out ORIGINAL, TRADITIONAL 510(K) NOTIFICATION

1. Start by gathering all necessary documentation, including device descriptions and labeling.
2. Identify the appropriate predicate device for comparison.
3. Complete the 510(k) cover sheet with the required information.
4. Fill out the 510(k) form with details about the device, including its intended use, technological characteristics, and performance data.
5. Provide comprehensive summaries of any preclinical and clinical studies conducted.
6. Include risk analysis and mitigation strategies.
7. Review and organize all submitted materials, ensuring they are clearly labeled and referenced.
8. Submit the completed 510(k) to the FDA along with the appropriate fee.

Who needs ORIGINAL, TRADITIONAL 510(K) NOTIFICATION?

1. Manufacturers intending to market a medical device that is substantially equivalent to an already legally marketed device.
2. Companies seeking permission to introduce new devices that may require regulatory oversight.
3. Entities looking to maintain compliance with the FDA's requirements for medical device marketing.

People Also Ask about

Is 510k the same as FDA approval?

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).

How long does FDA have to review a 510k?

The Traditional 510(k) may be used for any original 510(k) or for a change to a previously cleared device under 510(k). Subject to the FDA's acceptance review in accordance with the guidance Refuse to Accept Policy for 510(k)s, the FDA generally reviews Traditional 510(k) submissions within 90 days of receipt.

What does FDA 510k cleared mean?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

What does FDA 510 K clearance mean?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

What is a 510k equivalence FDA?

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) that is not subject to premarket approval.

What does 501k clearance mean?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

What is a traditional 510k?

A 510(k) is a submission containing information required under 21 CFR 807.87. All 510(k)s are based on the concept of substantial equivalence (SE) to a legally marketed device, also referred to as a predicate. All 510(k)s provide a comparison between the device to be marketed and the predicate device or devices.

How long does the FDA review traditional 510k?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days.

What happens after 510k clearance?

Once a device receives clearance, a company has 30 days to register the device with the FDA. If the company is new and has no devices on the market, it must also register as an establishment with the FDA, which incurs an annual fee. Some firms are surprised to learn that additional fees are involved in this process.

What is the difference between FDA approval and clearance?

This is because the distinction between approved and cleared is significant: While FDA-approved means that the FDA has decided that the benefits of the product outweigh the known risks and manufacturers have to submit a pre-market approval application–as well as clinical testing results–in order to get approved, FDA-

For pdfFiller’s FAQs

What is ORIGINAL, TRADITIONAL 510(K) NOTIFICATION?

The ORIGINAL, TRADITIONAL 510(K) NOTIFICATION is a pre-market submission made to the FDA to demonstrate that a medical device is safe and effective for its intended use, by showing that it is substantially equivalent to a legally marketed device.

Who is required to file ORIGINAL, TRADITIONAL 510(K) NOTIFICATION?

Manufacturers of medical devices intending to market a new device that is not exempt from premarket notification requirements and is substantially equivalent to a device already on the market are required to file an ORIGINAL, TRADITIONAL 510(K) NOTIFICATION.

How to fill out ORIGINAL, TRADITIONAL 510(K) NOTIFICATION?

To fill out the ORIGINAL, TRADITIONAL 510(K) NOTIFICATION, the applicant must complete the FDA Form 3514 and include details such as a description of the device, indications for use, labeling, performance data, and any existing predicate devices.

What is the purpose of ORIGINAL, TRADITIONAL 510(K) NOTIFICATION?

The purpose of the ORIGINAL, TRADITIONAL 510(K) NOTIFICATION is to provide the FDA with sufficient information to determine whether a medical device is safe and effective and can therefore be cleared for marketing.

What information must be reported on ORIGINAL, TRADITIONAL 510(K) NOTIFICATION?

The information that must be reported includes the device name, manufacturer details, intended use, complete device description, labeling, summary of technological characteristics, and any performance testing or clinical data relevant to the device's safety and efficacy.