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This document provides a summary of the 510(k) premarket notification submitted for the S-MiNi Implant System, a dental implant device intended for temporary support prosthetic devices during healing
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How to fill out 510k summary - accessdata
How to fill out 510(K) SUMMARY
01
Identify the device and its intended use.
02
Determine the appropriate predicate device.
03
Gather information on device description and specifications.
04
Conduct a risk assessment and summarize safety and effectiveness data.
05
Prepare labeling information, including instructions for use.
06
Compile detailed documentation of performance testing and clinical data.
07
Complete the FDA's 510(k) submission form.
08
Review the submission for completeness and accuracy before sending.
Who needs 510(K) SUMMARY?
01
Manufacturers of medical devices that are not exempt from 510(k) requirements.
02
Companies seeking to introduce devices that are similar to already cleared devices.
03
Importers of medical devices that require FDA clearance before marketing.
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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.
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What is 510(K) SUMMARY?
A 510(K) Summary is a document submitted to the FDA that provides information about a medical device to demonstrate that it is safe and effective, and substantially equivalent to a device already on the market.
Who is required to file 510(K) SUMMARY?
Manufacturers and importers of medical devices that are intended for human use in the United States are required to file a 510(K) Summary if they wish to market a device that is not exempt from premarket notification.
How to fill out 510(K) SUMMARY?
To fill out a 510(K) Summary, you must include relevant information about the device’s intended use, technological characteristics, comparison with predicate devices, safety and effectiveness data, and other regulatory information as required by the FDA.
What is the purpose of 510(K) SUMMARY?
The purpose of the 510(K) Summary is to demonstrate that the new medical device is substantially equivalent to an existing device that is already legally marketed, ensuring it meets safety and effectiveness standards.
What information must be reported on 510(K) SUMMARY?
Information that must be reported includes the device name, intended use, descriptions of the device, technological characteristics, performance testing data, labeling information, and any other relevant data to support the device's safety and efficacy.
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