FDA 510(k) Submission Services to Obtain 510 k Clearance from the FDA
Emergo Group helps support medical device companies from around the world seeking approval to sell their products in the United States. One of the first steps for medical device companies who manufacture Class II devices (and a very small number of Class I & III devices) is to file a Premarket Notification with the Food and Drug Administration, also known as an FDA 510 k application. A Predicate Device – that is a device similar to the one for which approval is being sought – must already be approved and exist on the US market. We have successfully prepared and submitted FDA 510 (k) applications for more than 100 companies worldwide.
See a diagram of the FDA 510 k approval process
Who must submit a FDA 510 (k) Premarket Notification to the FDA?
- Manufacturers or importer/exporters wishing to introduce a new device (for which a predicate device exists) to the US market.
- Manufacturers introducing a new finished device to the US market. If you manufacturer of a component, you may not need to file a FDA 510 (k) unless the component is also sold as a replacement part, or is a software product working in conjunction with devices.
- Specification developers that design a device and have it manufactured by another company for eventual sale in the US.
- Companies that are proposing a significantly different design or different Intended Use for a product that is already sold in the US.
- Repackagers or relabelers of devices.
See a list of devices EXEMPT from the 510 k approval process.
See the fees the FDA charges to review 510(k) applications
Our FDA 510 (k) submission and preparation services include:
- Verification that the predicate device(s) you have chosen to use in your submission meets the necessary criteria.
- Research the required information that you will need to provide to us based on FDA Guidance Documents.
- Contact the FDA Office of Device Evaluation to determine any additional requirements for their review of this product.
- Prepare the FDA 510 (k) submission.
- Submit the FDA 510 (k) application (or amendment) to the FDA in a consistent manner for all submissions.
- Coordinate and work with the client and FDA review team. Often additional questions or more substantiated data are requested by the FDA.
- Assist with the preparation of a response if the FDA has questions or requires additional information.
- Act as the official correspondent on the application and remain accessible to the FDA for any future discussions regarding the 510k submission.
- Monitor the progress of the FDA 510 (k) through the FDA review process and supply you with periodic updates as they become available.
- Prepare the Safety and Efficacy summary.
- Provide phone consultation during the FDA 510 (k) approval process.
Let Emergo Group's team of experienced medical device professionals assist you in submitting a successful FDA 510 (k) application for your medical device. Contact us today for a free consultation and pricing proposal.
