S
Sphinx
I would like to know if anyone has some feedback on our obligations as a manufacturer with respect to FDA and labeling (IFU) especially if we include a pre-cut suture with our device for convenience during the procedure.
Are we required to include / follow the labeling requirements for sutures as per FDA Guidance -Class II Special Controls Guidance Document: Surgical Sutures;Guidance for Industry and FDA.
The company supplying us with the suture has a 510(k) clearance for the sutures.
Appreciate your inputs.
Thanks
Anish
Are we required to include / follow the labeling requirements for sutures as per FDA Guidance -Class II Special Controls Guidance Document: Surgical Sutures;Guidance for Industry and FDA.
The company supplying us with the suture has a 510(k) clearance for the sutures.
Appreciate your inputs.
Thanks
Anish