It depends on many factors, including the intended use of the device, the device’s classification, and the type of changes being made to the device since the last filing. Consult with the FDA to help in making an informed decision. Generally speaking, premarket submissions should be made when the device has been thoroughly tested and any modifications or new features are adequate and safe to use.
It is recommended that device manufacturers submit a 510(k) when they make any of the following changes:
-The technology of the device is significantly different than that of legally marketed products in a way that could significantly affect safety or effectiveness of the product
-The intended use of the product is significantly different than that of legally marketed products
-The device is made with different materials or a different manufacturing technique than legally marketed products
-The device contains features or performance characteristics that are significantly different from legally marketed products.
about deciding when to submit a 510 k?
The FDA provides guidance on how to determine whether your medical device requires 510(k) clearance prior to marketing. Generally, if the device is “significantly different” from devices marketed prior to May 28, 1976, which are in commercial distribution (predicate devices), then it requires 510(k) clearance. A device is considered “significantly different” if it: (1) has different technological characteristics than its predicate device, (2) is intended for different use than its predicate device, or (3) is a combination product made up of different components or materials than its predicate device. Consider researching the product labeling on predicate devices to get a better understanding of their intended use. The ultimate decision lies with the FDA, so reviewing all relevant guidelines and consulting an expert can be helpful in understanding and determining when to submit a 510(k).
The decision as to when a 510 k should be submitted depends on the type and complexity of the device being marketed. According to the FDA, you should submit a Premarket Notification [510(k)] when your device is: (1) Significantly different from any legally marketed device; (2) is intended for a different purpose; or (3) involves a new technology. If your device does not meet any of the criteria above, then you should not submit a Premarket Notification. Additionally, you should review the specific guidance documents related to your device from the FDA’s website to determine whether or not you need to submit a 510k.
1. Center for Devices & Radiological Health (CDRH): https://www.fda.gov/cdrh/index.html
2. Food and Drug Administration (FDA): https://www.fda.gov/
3. MEDDEV 2.7/1: Guidelines on Medical Device Directive: https://ec.europa.eu/health/medical-devices/docs/meddev_2_7_1_en.pdf
4. UDIMA Medical Device Regulation Expert Blog: http://udima-md-reg.blogspot.com/
5. Global Harmonization Task Force (GHTF): https://www.ghtf.org/
6. International Medical Device Regulators Forum (IMDRF): http://www.imdrf.org/
7. National Institute of Medical Device Standards (NIMDS): http://nimds.nic.in/
8. European Commission Medical Device Database: http://ec.europa.eu/growth/sectors/medical-devices/database/
9. U.S. Department of Health & Human Services: https://www.hhs.gov/ essay should a manufacturer submit a 510 k for a product change?
Yes, manufacturers should submit a 510 k to the Food and Drug Administration (FDA) for any product changes, as this is a requirement of the FDA. A manufacturer must provide information to the FDA when they are changing or modifying any part of the product, its label, instructions, or packaging. This information provides assurance to both the FDA and consumers that the device still meets safety and efficacy requirements. The 510 k is a premarketing submission that must include information such as a summary of the device’s intended use, detailed descriptions of the device, product performance data, device components and features, clinical data, and labeling.