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Adipose tissue-derived materials
Press Release Lipogems

Does Lipogems Want Orthopedic Surgeons to Think It’s Okay With the FDA to Use Fat-derived Fuzz Balls to Treat Orthopedic Conditions Like Knee Osteoarthritis? Part Two

Physicians in the regenerative medicine community were startled to read a press release issued on July 5th  by Lipogems, which seemed to suggest that the FDA had reversed or at least modified the prohibition on using adipose tissue to treat musculoskeletal conditions the Agency just released in a Guidance on Minimal Manipulation and Homologous Use last...
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Lipogems Press Release

Does Lipogems Want Orthopedic Surgeons to Think It’s Okay With the FDA to Use Fat-derived Fuzz Balls to Treat Orthopedic Conditions Like Knee Osteoarthritis? Part One

While I hadn’t seen anything new recently on the fuzz balling front (e.g., using mechanical methods to beat up adipose tissue for lipofilling procedures), imagine my surprise to see a press release dated July 5th with the following headline: FDA Clears The Way: Lipogems’ Receives FDA Clearance For Microfragmented Adipose Tissue System Utilizing Body’s Own...
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CryoStem Warning Letter

American CryoStem Gets a Warning Letter About Obvious Issues With Its Services

A lot of folks think that following the rules laid down by the FDA can be a challenge, due to the uncertainty of words used in 21 CFR 1271 or alleged ambiguities in the Agency’s guidances issued to assist stakeholders to follow the right regulatory path. But, in the case of American CryoStem Corporation (ACSC;...
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Greyledge Hemoanalytic Data

Practical Implications for Physicians Wanting to Use the Lipogems System for Processing Lipoaspirate Part One

In the last two posts (When Fat Hits the Regulatory Fan: Mechanical Disruption of Adipose Tissue with the Lipogems System Part One andWhen Fat Hits the Regulatory Fan: Mechanical Disruption of Adipose Tissue with the Lipogems System Part Two), I reviewed a situation involving a 510(k)-cleared device/kit for mechanically disrupting a patient’s adipose tissue (i.e.,...
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Amniotic Fluid-derived Information

When Fat Hits the Regulatory Fan: Mechanical Disruption of Adipose Tissue with the Lipogems System Part Two

In the previous post When Fat Hits the Regulatory Fan: Mechanical Disruption of Adipose Tissue with the Lipogems System Part One, I introduced what I think is a curious situation that has resulted from instructions the FDA provided to physicians on how to review the standards outlined in 1271.15(b) to see if they can invoke the...
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Lipogems Adipose Tissue

When Fat Hits the Regulatory Fan: Mechanical Disruption of Adipose Tissue with the Lipogems System Part One

During my previous review(see posts): When the Fat Hits the Regulatory Fan: Processing Adipose Tissue in the “Such HCT/P” Era Part One When the Fat Hits the Regulatory Fan: Processing Adipose Tissue in the “Such HCT/P” Era Part Two of important and relevant points the FDA made in the two Guidances that were issued on...
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When the Fat Hits the Regulatory Fan: Processing Adipose Tissue in the “Such HCT/P” Era Part Two

In the previous post: When the Fat Hits the Regulatory Fan: Processing Adipose Tissue in the “Such HCT/P” Era Part One, I started reviewing relevant statements that I think might apply to adipose tissue in the two final Guidances the FDA issued on November 16, 2017 (see my views and the link below): Winners and...
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Safe Medical Environment

When the Fat Hits the Regulatory Fan: Processing Adipose Tissue in the “Such HCT/P” Era Part One

Prior to the FDA issuing the final versions of two Guidances (see my views and links below) Winners and Losers Emerge at Long Last After the FDA Issues Two Guidances  Same Surgical Procedure Exception Guidance: What Does “Such HCT/P” Really Mean? Part One Same Surgical Procedure Exception Guidance: What Does “Such HCT/P” Really Mean? Part Two...
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Same Surgical Procedure Exception Guidance: What Does “Such HCT/P” Really Mean? Part Two

In the previous post: Same Surgical Procedure Exception Guidance: What Does “Such HCT/P” Really Mean? Part One, I started exploring what I think the FDA is trying to tell us stakeholders in its recently issued Guidance entitled, “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception”. I...
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Same Surgical Procedure Exception Guidance: What Does “Such HCT/P” Really Mean? Part One

The FDA issued two Guidances on November 16, 2017; one on homologous use and minimal manipulation, and the other on the Same Surgical Procedure Exception in 21 CFR 1271.15. See, “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception” for the text of the Guidance. Also, see...
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