Get the free Special 510(k) Premarket Notification VF Gel - accessdata fda

This document provides a summary of the safety and effectiveness information for the VF Gel, a medical device submitted for premarket notification under the FDA's 510(k) process, indicating its intended

How to fill out special 510k premarket notification

How to fill out Special 510(k) Premarket Notification VF Gel

1. Review the criteria for submitting a Special 510(k) application.
2. Gather all necessary documentation, including the previous 510(k) clearance letter and any relevant data.
3. Complete the Special 510(k) form by filling in the device identification and manufacturer information.
4. Provide a summary of the modifications made to the device.
5. Include any performance testing data that supports the changes.
6. Prepare a declaration of conformity and standards used, if applicable.
7. Submit the completed application along with the required fee to the FDA.

Who needs Special 510(k) Premarket Notification VF Gel?

1. Manufacturers that have made minor modifications to a device already cleared under a previous 510(k) and need to demonstrate that the changes do not alter the intended use or safety of the device.
2. Companies seeking to expedite the review process for their device modifications while ensuring compliance with FDA regulations.

People Also Ask about

What is the difference between premarket notification and 510k?

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 the difference between traditional 510k and special 510k?

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 510 K premarket notification requirements?

A 510(k) Premarket Notification is required for low to moderate risk medical devices classified as either Class I or Class II and not exempt from 510(k). Companies are unable to market their products to health care providers, patients and other consumers until they are given 510(k) clearance by the FDA.

What is 510 k premarket notification?

The difference between the three types of 510(k) submissions comes down to how you prove substantial equivalence: Traditional 510(k): Prove substantial equivalence to a legally marketed predicate device. Special 510(k): Prove substantial equivalence to your own previously cleared device.

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.

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

Special 510(k)s allow FDA and industry to rely on previous Agency review of detailed information, where appropriate, without altering any statutory or regulatory requirements related to the premarket notification process under sections 510 and 513 of the FD&C Act, and 21 CFR 807 Subpart E.

How long does it take for the 510 K determination in the case of traditional 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.

For pdfFiller’s FAQs

What is Special 510(k) Premarket Notification VF Gel?

Special 510(k) Premarket Notification VF Gel is a submission process for medical devices that have undergone a modification in design, materials, or manufacturing that do not significantly affect the safety and effectiveness of the device.

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

Manufacturers of medical devices who are making modifications to devices that are already cleared for marketing must file a Special 510(k) if their changes are minor and do not affect the intended use or the safety and effectiveness of the device.

How to fill out Special 510(k) Premarket Notification VF Gel?

To fill out the Special 510(k) Premarket Notification, manufacturers should provide information regarding the device identification, descriptions of the modifications, a summary of the performance data, and any other relevant documentation that supports the changes made.

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

The purpose of the Special 510(k) Premarket Notification is to allow for a streamlined regulatory pathway for manufacturers to notify the FDA of certain modifications to medical devices that have already been found to be safe and effective.

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

Information that must be reported includes the device identification, a description of the modifications, indications for use, comparative performance analysis, compliance with applicable standards, and any new data to demonstrate continued safety and effectiveness.