510k Submission
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?
Examples of devices that may be cleared through a 510(k) submission include:
- Devices for general well-being
- Diagnostic imaging devices (MRI, X-ray, etc.)
- Devices used to collect and process blood samples
- Surgical instruments (laparoscopy, staplers, etc.)
- Devices used to diagnose and treat illness, injury, or disease
The Categories of Products for 510k Submission
510(k) submissions most commonly apply to Class I and Class II devices. Class I products are low-risk and many are exempt from premarket review. Class II devices carry moderate risk, and the manufacturer must submit scientific evidence demonstrating that the device is substantially equivalent to another legally marketed (predicate) device before the FDA will clear it.
What Information is Required for 501k Submission?
A 510(k) submission should include detailed information about the device’s performance and any potential risks of its use, including:
- The device’s intended use, specifications, and performance characteristics
- Functions carried out by the various system components
- How the design ensures the device can 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 directions for use and risks associated with incorrect use
- A full summary of all bench and/or animal tests performed on the device
- A description of the device’s components and materials, with specifications where relevant
- Any other information demonstrating that the product conforms with FDA requirements
Steps to Obtain FDA 510k Clearance
- Determine whether the device is substantially equivalent to another legally marketed device. If no suitable Class I or II predicate exists, FDA decides whether the device poses a significant risk or is substantially equivalent to an investigational device.
- If the device does not fit those criteria, or FDA cannot decide, FDA evaluates clinical trial data and other scientific evidence to assess the device’s safety and effectiveness.
- FDA evaluates the device’s indications for use, contraindications, warnings, precautions, adverse reactions, potential risks and benefits, dosing, and administration, and reviews how labelling requirements are met.
A 510(k) also requires an annual report on product changes made since clearance. You must notify the FDA 30 days in advance of any manufacturing changes expected to affect 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?
After receiving a submission, the FDA first confirms it is complete and accepted for review – this acknowledgement is not a clearance. Total time to clearance varies by device type and the quality of the submission, but commonly takes several months. A well-prepared submission with a clear predicate and complete data moves through review faster.
For more information about the 510(k) submission process, contact us. Our panel of experts will help you obtain FDA 510(k) clearance efficiently. You can also visit our frequently asked questions page.
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Frequently Asked Questions about 510(k) Submission
Is a 510(k) device "FDA approved"?
No. A 510(k) device is FDA cleared. "Approved" applies only to higher-risk devices that go through the FDA's Premarket Approval (PMA) pathway, and the FDA does not permit "FDA approved" labelling for 510(k) devices.
What is substantial equivalence?
It means your device is as safe and effective as a legally marketed predicate device, even if it has different technological characteristics, without raising new questions of safety or effectiveness.
How long does it take?
It varies by device and submission quality, but commonly several months from a complete submission to clearance.
Which device classes use a 510(k)?
Most 510(k)s are for Class II devices (and some Class I); the highest-risk Class III devices generally require PMA instead.