Labeling requirements for procedure pack



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.

Top Bottom