Get the free Premarket Notification 510(k) Summary - accessdata fda

This document summarizes safety and effectiveness information regarding the 510(k) premarket notification for Powdered Vinyl Patient Examination Gloves, including the device's intended use, technological

How to fill out premarket notification 510k summary

How to fill out Premarket Notification 510(k) Summary

1. Start by downloading the FDA's Premarket Notification 510(k) guidelines.
2. Gather necessary information about your device, including its intended use and technological characteristics.
3. Identify a predicate device that is legally marketed and similar to your device.
4. Provide a comprehensive description of your device, including specifications and performance data.
5. Include safety and effectiveness information, demonstrating that your device is at least as safe and effective as the predicate device.
6. Complete the 510(k) application form, ensuring all required fields are filled.
7. Prepare and include any relevant supporting documents, such as clinical data if needed.
8. Submit the 510(k) application electronically or in paper format, as per FDA requirements.
9. Respond to any additional requests or questions from the FDA during their review process.
10. Await FDA's decision and provide any further information if required.

Who needs Premarket Notification 510(k) Summary?

1. Medical device manufacturers seeking to market devices that are not exempt from the 510(k) process.
2. Companies introducing moderate-risk devices that are similar to existing FDA-cleared devices.
3. Entities looking to demonstrate that their new device is substantially equivalent to a predicate device.

People Also Ask about

What is the difference between premarket notification and 510k?

The first two sections of your 510(k) submission consist entirely of FDA forms for you to complete. Section 1.0 is the Medical Device User Fee Cover Sheet (FDA Form 3601) and Section 2.0 is the CDRH Premarket Review Submission Cover Sheet (FDA Form 3514). Seems pretty straightforward right?

What are the guidelines for 510k submission?

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 is included in a 510k submission?

The documentation must include drawings, schematics, and a description of the device's intended use and performance. Selection of the most appropriate predicate device — The 510(k) submission must include a comparison of the device under consideration to a predicate device already on the market.

What is a section 510k premarket notification of intent?

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. Applicants with outstanding review issues will be notified within 100 days.

What is the difference between 510k and premarket approval?

FDA PMA (Premarket Approval) It involves extensive clinical trials and laboratory testing and has higher standards than the 510(k) process, requiring more detailed and comprehensive evidence of the device's safety and effectiveness. The FDA has 180 days to review and decide on a PMA application.

What is an FDA premarket submission?

Pre-Submissions (Pre-Subs) The main purpose of the Pre-Sub Program (previously known as the Pre-IDE Program) is to provide the opportunity for a sponsor to obtain FDA feedback prior to an intended submission of an IDE or marketing application.

What are the elements of a 510 K premarket notification submission?

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 Premarket Notification 510(k) Summary?

A Premarket Notification 510(k) Summary is a document submitted to the FDA to demonstrate that a medical device is safe and effective by showing that it is substantially equivalent to a legally marketed device.

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

Manufacturers of medical devices that intend to market devices in the U.S. and believe that their devices are substantially equivalent to an existing device must file a Premarket Notification 510(k) Summary.

How to fill out Premarket Notification 510(k) Summary?

To fill out a Premarket Notification 510(k) Summary, manufacturers should provide detailed information about the device, including its intended use, description, technological characteristics, performance data, labeling, and any other relevant information that supports substantial equivalence.

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

The purpose of the Premarket Notification 510(k) Summary is to notify the FDA about a device that is intended to be marketed and to demonstrate that it is safe and effective for its intended use by establishing substantial equivalence to a device that is already legally marketed.

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

The information required in a Premarket Notification 510(k) Summary includes the device name, intended use, a description of the device, the predicate device information, summary of technological differences, any clinical data, labeling indications, and a declaration of conformity with FDA regulations.