Previously in posts Hello From Greyledge and Is There a Way to Refine the Practice of Regenerative Medicine?(opens in a new tab), I introduced Greyledge Technologies and the service it provides to physicians and surgeons who have decided to use platelet rich plasma (PRP) and bone marrow concentrated cells (BMCC) either as adjunctive therapy during a surgical procedure [...]
In the last post, I had initiated a review of some really odd comments by an attorney, Mr. Richard Jaffe, on what he considers to be the free-for-all nature of a section of 21 CFR 1271—the law that controls the creation and use of human-derived materials, known as HCT/Ps, which was published in 2001 in [...]
While I was settling in at my new job with Greyledge Technologies in Colorado, the FDA held a two-day stakeholder meeting to review four draft guidances the Agency wants to finalize. The four draft guidances are (in the order they were issued): Same Surgical Procedure Exception (October, 2014; source(opens in a new tab)) Minimal Manipulation (December, 2014; source(opens in [...]
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