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TOPIC: FDA exposure draft

FDA exposure draft 25 Oct 2014 09:27 #2528

  • fas
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Regulatory News: Not Good for the USA. Stronger constraints on Clinical applications of autologous cellular therapies.

" the criteria of “minimal manipulation” expressed in 21 CFR 1271.10 (a) is not the standard for establishing whether an HCT/P is “such HCT/P” under § 1271.15. Accordingly, even manufacturing steps considered minimal manipulation within § 1271.10(a), will typically cause the HCT/P to no longer be “such HCT/P” under §1271.15(b), unless the HCT/P is only rinsed, cleaned, sized, or shaped.

Or maybe good news for companies like Cytori which have been strictly working according to the rules and have a good relation with the FDA. This basically means- there is nobody as a process or device that can claim "minimal manipulation"-

This is what Chris Centeno said on the issue:

Alexey, it will be interesting to see how FDA deals with the 510K approved devices that use centrifugation and are used for PRP and BMC, as there would then be a conflict between that device and the new 1271.15(b) regs. Having said that, if they use regulatory disgression on that issue with PRP and BMC, then this is certainly lights out for the burgeoning SVF industry where no 510K approved predicate exists.

Alexey Bersenev wrote an article on the draft, which is good and understandable.:

Link here: Alexey article

Draft attached for download

File Attachment:

File Name: SSPEdraftguidance2014-208.pdf
File Size: 63 KB
The following user(s) said Thank You: d9dozrman

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

FDA exposure draft 25 Oct 2014 10:12 #2529

  • myownhedgefund
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It will be interesting to see how enforcement is applied and how long it takes.

US government agencies arent exactly know for speed.

Still, hopefully it ends a frustrating aspect of stem cell therapy that others circumvented the FDA route and prospered while we floundered.

Thanks for sharing

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