What is a 510k Submission?
Medical device makers use the 510k premarket notification to legally market a new medical device. This procedure necessitates the submission of technical data to the Food and Drug Administration (FDA) on a prescribed form known as a Premarket Notification (510k) Application, which is then examined by FDA scientists for safety, effectiveness, and labelling. A company’s 510k submission is a crucial document. It certifies to the agency that your product complies with public health and safety regulations, allowing you to list it as an FDA-approved device on your marketing labels.
What Devices Require 510k Submission?
The following are some examples of devices that may be cleared by 510k submission:
- Devices for general well-being
- Imaging devices for diagnostic purposes (MRI, XRAY, etc.)
- Blood samples that are collected and processed
- Surgical instruments (laparoscopy, staplers, etc.)
- Devices that can be used to diagnose and treat illness, injury, or disease.
The Categories of Products for 510k Submission
510k submissions are divided into two categories by the FDA: Class I and Class II.
Class I products are low-risk and do not need to be reviewed before being sold. Class II devices, on the other hand, pose moderate to higher risks than Class I devices, and firms must submit scientific evidence demonstrating that their device is substantially identical to another legally marketed product before the FDA will approve it.
What Information is Required for 501k Submission?
A 510k submission should include extensive information about the device’s performance as well as any potential dangers associated with its use. The following items should be included in the 510k submission:
- The device’s intended use, as well as its specifications and performance qualities;
- Functions carried out by various system components
- How the product’s design ensures that it may be used safely and effectively
- Any performance or product attributes that are difficult for the user to assess
- A description of the device’s labelling, including the device’s directions for use and any potential risks connected with incorrect use
- A full summary of all bench and/or animal tests that have been done on your device
- A description of the device’s components and materials, including, where relevant, the specifications for each component or assembly
- Any other information that demonstrates that your product conforms with FDA requirements.
Steps to Obtain FDA 510k Clearance
The 510(k) clearance procedure consists of three stages:
Stage 1:The first step is to see if the product under consideration is substantially equivalent to another legally marketed device. If no legally marketed Class I or II devices meet this requirement, FDA will decide whether the device poses a significant risk or is substantially equivalent to an experimental device.
Stage 2: If FDA determines that the new device does not fit the criteria for either of these categories or if they are unable to decide whether it does, FDA will evaluate data from clinical trials and other scientific evidence to assess the proposed 510(k) device’s safety and effectiveness.
Stage 3: The third phase is to evaluate the proposed device’s indications for use, contradictions, warnings, precautions, adverse reactions, potential risks and benefits (including any countermeasures), doses, and administration. During this step, relevant techniques for ensuring that certain labeling criteria are met will be evaluated.
A 510k submission also necessitates an annual report on any product changes made since its first marketing approval or clearance. You must notify the FDA 30 days in advance of any manufacturing modifications that are expected to impair the device’s safety or effectiveness.
The Cost of 510k Submission
510k submissions can cost anywhere from $4,000 to $12,000 depending upon the 510k examiner’s opinion of the submission. However, the fees vary greatly depending upon the complexity of your device.
How long does it take to be Approved after 510k Submission?
A 510k submission must be responded to by the FDA within 60 days of receipt. This response, however, is not a clearance; rather, it is a notification that your application has been completed and approved for review. Under the standard 510k submission procedure, clearance takes an average of 177 days or nearly six months. The average time it takes to clear a device through the 510k submission process varies by device category.
Visit our 510k submission frequently asked questions page to learn more!
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