A Overview of the FDA 510(k) Approval Process
The 510(k) process applies to nearly all Class II medical device in the US and a small number of specific Class I devices as well. Assuming you have determined that your medical device does need a 510(k), here is how the process works.
STEP 1: Compile the information needed and prepare the submission
First, you will need to have specific information available that will be required in the application. This may include, but is not limited to:
- Statement of Intended Use for the device
- Description of how it operates
- Technical drawings, diagrams and pictures of the device
- Technical characteristics of your device compared to others already approved
- Proposed labeling, marketing materials and Instructions for Use
- Differences in your product compared to the "predicate" devices already approved by the FDA and how this may affect safety
- Testing data, including clinical data if applicable
- Maintenance and troubleshooting procedures, if applicable
- Compliance with any published Standards or Guidelines, if applicable
This is simply a part list of everything that goes into the 510k. Because the FDA does not have a template for 510(k) submission, you need to figure out how to meet their requirements in submitting all of this information.
STEP 2: The FDA reviews your 510(k) application
Once you have submitted your 510(k) to the FDA, they legally have 90 days to review it. During that process, they may ask you for additional information at which time the "clock" is stopped and then resumed upon the FDA's receipt of your answer to their questions. If approved, the FDA will mail you a letter, with an assigned 510(k) number, that says they "have determined that your device is substantially equivalent to legally marketed predicate devices...and you may therefore market the device subject to general controls provisions of the (Food, Drug and Cosmetics) Act" Essentially, when they send you the letter, they are not approving your device, they are saying that your device is much the same as other devices (predicates) already approved by the FDA. You will not receive a certificate from the FDA, but this letter will be available on the FDA database as proof to your customers that your product is approved for sale in the US.
STEP 3: Register your company and device with the FDA
Once you have received your FDA 510(k) "clearance" letter, the final step is to complete the FDA device listing and establishment registration using the FURLS system on the FDA website. You are then open to random inspections for compliance with Good Manufacturing Practices. There are also certain fees that must be paid.
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