The 510(k) review program is for manufacturers of low class medical devices who are required to prove substantial equivalence with a pre-cleared medical device on the US market. BSI is one of the independent bodies accredited by the US Food and Drug Administration (FDA) to conduct 510(k) reviews under the third party review program.
This program allows manufacturers of eligible devices to have their 510(k) submission reviewed by a third party instead of the FDA. The third party will review the submission and make a recommendation to the FDA where it decides substantial equivalence has been established. The FDA will review the recommendation and if acceptable permit clearance.
Where a manufacturer is interested in the option of using the program, the following process should be followed:
- Confirm that the devices in question are within the scope of the program. A list of devices currently eligible for 510(k) review can be found at the FDA CDRH website.
- If the device is eligible, check that it is within the scope of BSI. A current list of the scope of third parties is listed at the FDA CDRH website.
- Receive a cost estimate from BSI. You should submit device details to BSI Medical Certification in order for us to provide you with a cost estimate.
- Confirm acceptance of the cost estimate and submit the required 510(k) documentation to BSI Medical Certification for review.
BSI would expect the 510(k) review to be completed and submitted to the FDA for clearance within 30-60 days of receipt of the submission (all relevant and required documentation). BSI's target is to submit within 30 days. The FDA has indicated that it will complete the review of a completed 510(k) review within 30 days. These times are targets and are subject to timely responses to queries and questions of the manufacturer.
For further information about BSI and the US FDA Third Party 510(k) Review Program, please Contact Us.
