A Special 510k may be an appropriate submission for a modification to a medical device that already has an FDA 510(k) clearance.
The Special 510k Approval Process allows the medical device manufacturer to declare conformity with the Design Controls set out of 21 CFR Part 820 without providing the data.
The Special 510(k) also applies to Preamendment Devices approved before May 28, 1976.
ISOplan USA can help you in the decision if a Special 510(k) submission is appropriate for your medical device or IVD (In Vitro Diagnostics) by evaluating each modification against specific criteria to make sure the modifications do not affect either the intended use or alter the scientific technology of your medical device. Of course our FDA 510(k) consultants can prepare the required documentation for your Special 510(k) submission.
For further information about the FDA 510(k) Approval Process please check the following links:
- FDA 510(k) Clearance Consulting for Medical Devices
- Traditional 510(k) for Medical Devices and IVD’s (In Vitro Diagnostics)
- Abbreviated 510(k) for Medical Devices and IVD’s
- List of Medical Devices Exempt from the FDA 510(k) Procedure
- How to Determine if a Medical Device is Substantially Equivalent (SE) to a Predicate Device for an FDA 510(k) Clearance Process