When the FDA Comes A Knockin’

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 or as a primary, percutaneous treatment for a variety of orthopedic indications, including pain mitigation. Admittedly, what I wrote about was my very recently acquired view of Greyledge and what I think some of the advantages are of Greyledge’s approach to providing autologous PRP and BMCC preparations, with a novel feature of performing a sample analysis of each preparation.

What I would like to cover in this post is how Greyledge Technologies is viewed by the FDA, as revealed in an EIR (Establishment Inspection Report) that it just recently received following the FDA’s facility audit conducted during August, 2016. Why would the FDA come a knockin’? Because Greyledge’s founder, Dr. David Karli, intentionally registered with the FDA about 6-7 years ago and has continued to maintain its registration on an annual basis.

For those who find it hard to believe that a company would voluntarily register with the FDA in this age of regenerative medicine shirkers and opportunists (and you know who you are), I offer up the company’s FEI: 3008724474, and the registration page for Greyledge on the FDA website(opens in a new tab). As a prelude to registration, Dr. Karli created and adopted a quality documentation system to standardize the processing and analysis of patient-derived samples. In other words, Dr. Karli decided to follow established regulatory requirements as much as possible, because he was and remains an advocate for the use of PRP and BMCC at point-of-care (POC) under controlled conditions.

Dr. Karli believes that sample analysis is a vital component of having a controlled process, since it provides key information about the sample prior to injection. One benefit of the Greyledge process is that the attending physician is able to review the sample data prior to treatment and make adjustments accordingly. The physician also can record key values, like total number of platelets, in a spreadsheet to be paired with patient outcomes following treatment in a kind of internal registry. Thus, the Greyledge approach provides a firm foundation on which to build quality into a clinic’s practice of medicine.

And that element of quality is tied back to the registration of the laboratory operation in Vail Valley, Colorado that provides processing services to The Steadman Clinic and the Vail Valley Medical Center.

How does the FDA characterize Greyledge Technologies? Well, the annual registration renewal is via Form FDA 2830, which is associated with “Blood Establishment Registration and Product Listing”. Greyledge fits into the category of “component preparation and collection facility” that works with autologous whole blood, and provides access to platelets, leukocytes/granulocytes and plasma. So, Greyledge operates in the broad area of blood-related products, including PRP and BMCC.

But we also work with bone marrow aspirate samples to produce bone marrow concentrated cells (BMCC)—wouldn’t that be in a different category? The simple answer is “No”, but it would take a while to explain why the FDA considers all blood-containing materials, like bone marrow aspirate, as falling in the category of “Blood”. For example, the Center for Biologics Evaluation and Research (CBER) has jurisdiction over devices to make PRP, which includes devices that accept 100% whole blood, as well as devices that accept 1/3 bone marrow aspirate mixed with 2/3 whole blood. But regardless of the input material, all that you can say in your instruction sheet for the device is that the output of the device is called “PRP”. Greyledge doesn’t have a device to process the patient material, but instead has a laboratory, which is registered with the FDA, so the rules we follow are somewhat different compared to the companies that make single-use disposable device technology.

The FDA wrote in the EIR from the most recent audit that,

“…this firm operates as Surgical Center operation that provides PRP, Platelet Rich Plasma, for use during orthopedic procedures. The PRP is generated and administered in the same day.”

It is pretty obvious that the FDA recognizes and is aware of the activities of Greyledge, since it acknowledges that we operate as a “surgical center” operation to support a physician’s decision to use PRP and, its blood relative, BMCC.

It was an important milestone for Greyledge Technologies to have undergone its second audit from the FDA, to pass the audit with no deviations noted and no corrective actions required (i.e., no 483 was issued). Clearly, Greyledge is a known quantity to the FDA by passing two FDA audits. Given that background, Greyledge is confident it can support physicians who want to provide a high-quality, and well-documented, PRP and BMCC service to their patients.