Special 510(k) is used for submission, review and clearance when modifications are made to an existing legally marketed predicate device of the same manufacturer that is already authorized for commercial distribution.
The types of changes that are accepted under Special 510(k) are:
- Some changes to Indications for Use
- Certain type of changes to technological characteristics.
- Labeling or design change to a legally marketed device if
- The manufacturer legally authorized to market the predicate device submits the proposal
- Performance data may or may not be necessary. If necessary, established methods should be in place to evaluate changes made
- Substantial equivalency can be supported using the required performance data reviewed in summary or risk analysis format.
What are conditions on which a software as a medical device can submit a special 510k?
If the raw material of a 510k approved medical device is changed require a special 510k or a new 510k?