An example of a combination product would be Stryker’s Vitagel Hemostat (http://www.stryker.com/en-us/products/Orthobiologicals/SoftTissue/Vitagel/index.htm). The delivery system for this product is a syringe and the primary mode of providing a therapeutic effect comes from the contents of the syringe which is the combination of microbibrillar collagen with thrombin, fibrinogen, and platelets. If I had to determine what approval channel this material would go through I would have assumed CBER, since it uses biologics to achieve it’s end goal. However, while researching I found that this specific device was approved by CDRH. Attached is the letter of approval (https://www.accessdata.fda.gov/cdrh_docs/pdf5/P050044A.pdf). Since this product underwent the CDRH approval it would require a PMA and clinical trials to show efficacy of the product and this is exactly what was done. Any thoughts on why it was CDRH that evaluated this product and not CBER.

More details on the product approval. (https://www.accessdata.fda.gov/cdrh_docs/pdf5/P050044B.pdf)