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A regulatory submission to the FDA detailing the substantial equivalence of a new robotic surgical device intended for orthopedic procedures, including knee and hip surgeries, along with its technological
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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 if your device requires a 510(k) submission.
03
Collect the necessary information including device description, indications for use, and technological characteristics.
04
Compare your device to a legally marketed predicate device.
05
Conduct performance testing and gather supporting data.
06
Prepare the 510(k) submission including the required documents and forms.
07
Submit the 510(k) electronically via the FDA's electronic submission system.
08
Pay the associated FDA user fee.
09
Respond to any requests for additional information from the FDA.
10
Await clearance or additional instructions from the FDA.
Who needs 510(K) SUMMARY?
01
Manufacturers of medical devices that are not exempt from premarket notification.
02
Companies seeking to introduce a new device that is similar to one already on the market.
03
Entity wanting to market a device that may affect safety and efficacy of existing devices.
04
Existing manufacturers modifying a device’s intended use or technological characteristics.
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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?
The 510(k) Summary is a document submitted to the FDA that provides evidence that a medical device is substantially equivalent to a legally marketed device.
Who is required to file 510(K) SUMMARY?
Manufacturers of medical devices that intend to market a new device that is not exempt from premarket notification requirements must file a 510(k) Summary.
How to fill out 510(K) SUMMARY?
To fill out a 510(k) Summary, manufacturers should include device information, intended use, performance data, labeling, and comparisons to predicate devices.
What is the purpose of 510(K) SUMMARY?
The purpose of the 510(k) Summary is to demonstrate that the new device is safe and effective by comparing it to an existing legally marketed device.
What information must be reported on 510(K) SUMMARY?
The 510(k) Summary must include device name, classification, identification of predicates, description of the device, intended use, technological characteristics, performance data, and labeling.
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