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This document summarizes the safety and effectiveness information for the ABX PENTRA devices submitted for premarket notification, including details on reagents, controls, and calibrators for use

How to fill out premarket notification 510k summary

How to fill out Premarket Notification [510(k)] Summary

1. Begin with the identification of the device including its brand name and common name.
2. Provide the classification and product code of the device.
3. Include a description of the device, including its intended use, design specifications, and materials.
4. Explain how the device is substantially equivalent to a legally marketed device.
5. Summarize the non-clinical and clinical data that supports the safety and effectiveness of the device.
6. List the relevant standards and guidance documents used for device development.
7. Provide detailed labeling information, including instructions for use.
8. Submit supporting documents, test results, and any other required information.
9. Review the summary to ensure all required elements are included and clear.
10. Sign and date the submission before submitting it electronically to the FDA.

Who needs Premarket Notification [510(k)] Summary?

1. Manufacturers of Class II medical devices that are not exempt from the 510(k) process.
2. Companies planning to market a new medical device that may be similar to existing devices.
3. Organizations looking to modify an existing device that affects its safety or effectiveness.

People Also Ask about

What is the process of pre market approval?

The PMA process involves a comprehensive scientific and regulatory review of the medical device. The applicant must provide valid scientific evidence to demonstrate the device's safety and effectiveness for its intended use(s).

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.

How long does it take for the 510 K determination in the case of traditional 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 is pre-market notification?

Premarket notification is the process through which these new devices claim substantial equivalency to a preexisting device and are automatically classified into the same class as that predicate device.

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 pre market notification process?

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 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.

For pdfFiller’s FAQs

What is Premarket Notification [510(k)] Summary?

Premarket Notification [510(k)] Summary is a submission made to the FDA to demonstrate that a medical device is safe and effective based on its substantial equivalence to a legally marketed device.

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

Manufacturers of certain medical devices that are intended for commercial distribution in the United States must file a Premarket Notification [510(k)] Summary if their device is not exempt from premarket notification.

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

To fill out a Premarket Notification [510(k)] Summary, manufacturers must provide detailed information about the device, including its intended use, technological characteristics, labeling, and a comparison to a predicate device.

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

The purpose of Premarket Notification [510(k)] Summary is to establish that the new device is as safe and effective as an already legally marketed device, allowing it to be marketed without undergoing the full premarket approval process.

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

The report must include the device name, classification, substantial equivalence claim, intended use, description of the device, summary of technological characteristics, and any relevant clinical data.