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This document provides a summary of the 510(k) premarket notification for the BladderScan® BVM 9500 Ultrasound System, detailing device information, intended uses, and comparisons to predicate devices

How to fill out 510k summary - accessdata

How to fill out 510(K) SUMMARY

1. Identify the device you are submitting and confirm that it requires a 510(k) submission.
2. Gather all necessary documentation, including device description, intended use, and labeling.
3. Provide information about the predicate device(s) you are using for comparison.
4. Detail the technological characteristics and performance data that demonstrate substantial equivalence.
5. Include a summary of any testing performed and results obtained.
6. Complete the 510(k) application form and organize all documents according to FDA requirements.
7. Submit the 510(k) SUMMARY electronically or as required by the FDA.

Who needs 510(K) SUMMARY?

1. Manufacturers of medical devices that are to be marketed in the U.S. and must demonstrate that their device is substantially equivalent to an already marketed device.
2. Companies seeking to modify an existing device and need to demonstrate that modifications do not affect safety or efficacy.
3. Importers of medical devices who must ensure compliance with FDA regulations.

People Also Ask about

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 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.

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.

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.

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 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.

For pdfFiller’s FAQs

What is 510(K) SUMMARY?

The 510(k) Summary is a regulatory submission to the FDA that demonstrates that a medical device is safe and effective by providing information that proves it is substantially equivalent to a legally marketed device.

Who is required to file 510(K) SUMMARY?

Manufacturers of medical devices intended for commercial distribution in the U.S. are required to file a 510(k) Summary if their device is not exempt and is not classified as a Class III device.

How to fill out 510(K) SUMMARY?

To fill out a 510(k) Summary, a manufacturer must complete a form detailing device information, intended use, technological characteristics, and comparisons to identified predicate devices, along with supporting data and evidence.

What is the purpose of 510(K) SUMMARY?

The purpose of the 510(k) Summary is to provide the FDA with sufficient information to determine if the new medical device is substantially equivalent to existing devices, thereby ensuring safety and effectiveness before market entry.

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

The 510(k) Summary must report information including the device's name, intended use, description, classification, predicate device comparisons, and supporting data regarding safety and effectiveness.