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This document summarizes the 510(k) premarket notification for the Proclear UltraVue Multifocal Toric contact lenses, detailing their intended use, device identification, and regulatory classification.

How to fill out premarket notification - accessdata

How to fill out Premarket Notification

1. Identify the medical device for which you are submitting the Premarket Notification (510(k)).
2. Determine the appropriate regulatory pathway based on the device classification.
3. Gather all necessary documentation, including device description, intended use, and labeling.
4. Conduct a comparison with a legally marketed device (predicate device) to demonstrate substantial equivalence.
5. Complete the FDA Form 3514, providing detailed information about the device and the submission.
6. Prepare any additional data required, such as safety and effectiveness data, if applicable.
7. Review all materials for completeness and accuracy.
8. Submit the completed 510(k) application to the FDA electronically or via paper submission.
9. Pay the appropriate user fee, if required.
10. Await confirmation from the FDA regarding the acceptance of your submission and any follow-up requests.

Who needs Premarket Notification?

1. Manufacturers of medical devices intending to market them in the United States.
2. Companies seeking to market a device that is substantially equivalent to an already legally marketed device.
3. New companies entering the medical device market or existing companies introducing modifications to their devices.

People Also Ask about

What does premarket notification mean?

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).

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 510k and premarket approval?

These two pathways determine the speed, complexity, and cost of your product's approval. While 510(k) clearance is used for most Class II devices with existing market equivalents, PMA (Premarket Approval) is required for high-risk or entirely novel Class III products.

What is a 510 K premarket notification?

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 are the different types of premarket submissions?

Rob MacCuspie, Manager of Regulatory Affairs at Proxima, is here to help growing MedTech companies learn about the three primary types of FDA pre-market submissions – 510(k), de novo and pre-market approval (PMA). For each submission type, learn what goes into each risk level and classifications.

What are the different types of premarket notifications?

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.

For pdfFiller’s FAQs

What is Premarket Notification?

Premarket Notification, also known as 510(k), is a submission made to the FDA to demonstrate that a medical device is safe and effective and substantially equivalent to a legally marketed device.

Who is required to file Premarket Notification?

Manufacturers of medical devices that are intended for commercial distribution in the United States must file a Premarket Notification if their device is not exempt from this requirement.

How to fill out Premarket Notification?

Filling out a Premarket Notification involves providing detailed information about the device, including its intended use, technological characteristics, labeling, and clinical data if applicable, using the FDA's 510(k) submission format.

What is the purpose of Premarket Notification?

The purpose of Premarket Notification is to ensure that new medical devices are safe and effective for their intended use and to provide the FDA with the necessary information to assess the product's regulatory compliance.

What information must be reported on Premarket Notification?

The information required includes the device name, manufacturer details, intended use, description of the device, comparison with a predicate device, labeling, and any supporting data such as performance testing or clinical studies.