Get the free 510(k) SUMMARY - accessdata fda

This document provides a summary of the 510(k) premarket notification for the Ponto Bone Anchored Hearing System by Oticon Medical, including its intended use, indications, and performance data.

How to fill out 510k summary - accessdata

How to fill out 510(k) SUMMARY

1. Identify the device that you are submitting for 510(k) clearance.
2. Gather all necessary documentation, including the device description, intended use, and technological characteristics.
3. Compile a list of any predicates (similar devices already cleared by the FDA) to demonstrate substantial equivalence.
4. Provide results from any testing that have been conducted, such as clinical, performance, or safety tests.
5. Draft the executive summary, clearly summarizing the purpose of the submission and the basis for substantial equivalence.
6. Prepare the labeling information and any recommended usage instructions.
7. Include any other required information as specified by the FDA guidance documents.
8. Submit the completed 510(k) SUMMARY electronically through the FDA's submission portal.

Who needs 510(k) SUMMARY?

1. Manufacturers of medical devices that intend to market a device in the United States.
2. Companies that are introducing a device that is similar to an already marketed device.
3. Organizations seeking FDA clearance to ensure their device meets safety and effectiveness standards.

People Also Ask about

What is the rejection rate for 510k?

The FDA 510(k) submission process is a critical gateway for medical device manufacturers seeking approval for their products in the United States. However, a concerning trend has emerged – a staggering 25% of these submissions are facing rejection due to lack of completeness.

What is the 510k decision making process?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the device's intended

What is the 510k pathway?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the device's intended

What is the 501k process?

The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of similarities to a current medical device that is already on the market.

How long does 501k approval take?

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.

How long does it take to get a 510 K approval?

It is worth noting that the most common time window to clearance (median) is 80-90 days, followed very closely by 50-60 days.

What is the purpose of a 510 K to determine?

The focus of the 510(k) process is to prove something called 'substantial equivalence'. In other words, the aim of the game is to prove to the FDA that the medical device you want to bring to market is broadly similar to another device that's already on the market, known as a predicate device.

For pdfFiller’s FAQs

What is 510(k) SUMMARY?

The 510(k) SUMMARY is a document submitted to the FDA that provides information about a medical device to demonstrate its substantial equivalence to a legally marketed device.

Who is required to file 510(k) SUMMARY?

Manufacturers of medical devices that are seeking FDA clearance for new devices that are not exempt from 510(k) requirements are required to file a 510(k) SUMMARY.

How to fill out 510(k) SUMMARY?

To fill out the 510(k) SUMMARY, manufacturers must provide details such as device description, intended use, technological comparison to predicate devices, safety and effectiveness data, and labeling information.

What is the purpose of 510(k) SUMMARY?

The purpose of the 510(k) SUMMARY is to ensure that new medical devices are safe and effective by demonstrating they are substantially equivalent to existing devices that are already on the market.

What information must be reported on 510(k) SUMMARY?

The 510(k) SUMMARY must report information including the device name, intended use, a description of the device, comparisons to predicate devices, performance data, and labeling.