To market a Medical Device with available legally marketed devices in the USA, it is mandatory to submit a 510(k) Premarket Notification to the US FDA, to confirm the device’s safety and efficacy, on par with the predicate device for a US FDA Medical Device Approval. The 510(k) Premarket Notification process is undertaken majorly for Class II Medical Devices and few Class I and Class III Medical Devices.
Who Should Submit a 510(k)?
It is required for domestic manufacturers, foreign manufacturers / exporters or the US Agents of foreign manufacturers / exporters and specification developers, while introducing a Medical Device in the U.S. market. Repackers or relabelers, who make labeling changes or whose operations significantly affect the device, must also submit a 510(k) Premarket Notification.
Types of 510(k) Application
There are 3 types of 510(k) applications that can be submitted to the US FDA for device evaluation and approval.
- Traditional 510(k) – Manufacturers can opt to submit a Traditional 510(k) application for any original 510(k) or for a change to a previously cleared device under 510(k).
- Special 510(k) - Manufacturers can make a Special 510(k) submission, when a 510(k)-cleared device has been modified after the notification, if the modification does not affect the intended use or does not alter the fundamental scientific technology of the device.
- Abbreviated 510(k) - Manufacturers can make an Abbreviated 510(k) submission, when device guidance documents are available and a special control is established for the device.
Apart from these approaches, FDA also has a ‘Quality in 510(k) Review Program Pilot’ (“Quik”) program. It is an alternative method for preparing a 510(k) application through the FDA’s eSubmitter software, which is piloted for a selected list of device types, mainly for moderate risk devices.
To assist manufacturers with compliant 510(k) submissions and 510(k) approval, Freyr provides support in compiling the device information for the submission, via e-submission platform, along with needed assistance in examining substantial equivalence to predicate device.
- Comprehensive US FDA Regulatory strategy
- Predicate Device Identification
- Establishing Substantial Equivalence with Predicate Device
- Gap Analysis for US FDA Compliance
- Compilation of 21 sections of 510(k) Technical File
- Publishing and creation of eCopy
- Validation and submission of eCopy
- Liaising services for Device Approval
- Addressal of RTA response and deficiencies
- Consultation services for addressing deficiencies
- Device Listing & FURLS database maintenance
- Have handled many 510(k) registrations of diversified device categories
- Expert team for 510(k) compilation as per US FDA 510(k) requirements
- Additional support to handle 510(k) queries
- Advice for the suitable type of 510(k) as per US FDA 510(k) submission requirements for the device
- On-time submission of deliverables
- Up to date with US FDA new amendments