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510 (K) Flowchart

The document discusses the 510(k) pathway for medical devices to gain market entry in the US. The 510(k) process requires identifying a similar "predicate device" that has already received FDA authorization. If a predicate exists, a 510(k) application can be prepared within 45 days with the required documents to show the new device is substantially equivalent. The FDA then has 80 days to respond by requesting additional information or providing marketing authorization. Once approved, manufacturers must register with the FDA but are subject to inspection for quality standards.

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Larryag12196
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414 views1 page

510 (K) Flowchart

The document discusses the 510(k) pathway for medical devices to gain market entry in the US. The 510(k) process requires identifying a similar "predicate device" that has already received FDA authorization. If a predicate exists, a 510(k) application can be prepared within 45 days with the required documents to show the new device is substantially equivalent. The FDA then has 80 days to respond by requesting additional information or providing marketing authorization. Once approved, manufacturers must register with the FDA but are subject to inspection for quality standards.

Uploaded by

Larryag12196
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

510(k) PATHWAY TO MARKET ENTRY

The majority of medical devices that enter the US market require the submission of a
FDA application known as a 510(k). A 510(k) is needed for a few Class 1 devices, for
nearly all Class 2 devices and can be used for a very small amount of Class 3 devices.
The following diagram will help you understand the 510(k) application process

PREDICATE DEVICE
You need to identify if another device that is very similar to
yours has already received FDA authorization for market. If
this has happened, it can be used to support your application
as a predicate device

YES
NO
A 510(K) application can be
Your device is entirely
prepared and submitted in
different from any others
approximately 45 days as
authorized by the FDA and
long as all required
may be new technology
documents are available

Devices that are of a common family You may need to conduct clinical trials
can frequently be submitted in a single and apply for an IDE or PMA. This will
510(k) require more time and can be costly.

The FDA has 80 days to respond after


submission. They will then either ask CSI can assist you in deciding which
questions or will present you with a pathway you will need to follow. We are
letter of authorization. experienced in both applications

CONGRATULATIONS!
If your submission is approved, your Once the forms have been filed,
company will need to file 2891 & 2892 you are approved to sell your
forms online to register your company product in the United States.
and device
Your company is now subject to FDA
inspection for GMP standards at ANY
TIME no matter where your company is
located.

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