Humanitarian Exemption, definition in progress : fda.gov

[Slackwater]

The term "humanitarian exemption" was read in a couple of places, ISSLS journal abstract(s), again recently the 2008 NASS abstracts specifically regarding multi-level ADR , TDR TDA ( two (2) or more levels ). I am a layperson, not a medical professional, regulatory lawyer, blah blah ...

"Humanitarian exemption" may be defined in one of the documents below. More reading required. Excerpts from a an existing humanitarian exemption (Stryker Biotech OP-1) document follows LINK:

"As defined in the Federal Food, Drug,
and Cosmetic Act (21 CFR 814.124), the definition
of a Humanitarian Use Device (HUD) is a device
that is intended to benefit patients in the
treatment and diagnosis of diseases or conditions
that affect or is manifested in fewer than 4,000
individuals in the United States per year. "

FDA developed and published the Safe Medical Devices Act
on June 26, 1996 to provide an incentive that would
encourage innovative manufacturers, ... DEL.TEXT
development of devices that would benefit only a
small patient population each year. "

Started with FDA, CBER (Center for Biologics Evaluation and Research) looking for OP-1, rhBMP-7 reference to Intervertebral Disc, DegDiscDisease and www.clinicaltrials.gov . I worked backwards(?).

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slackwater_sf
mva, 2-level lumbar surgical candidate

[Slackwater]

Originally Posted by Slackwater

existing humanitarian exemption (Stryker Biotech OP-1) document follows (DEL.TEXT)

Started with FDA, CBER (Center for Biologics Evaluation and Research) looking for OP-1, rhBMP-7 reference to Intervertebral Disc, DegDiscDisease and www.clinicaltrials.gov .

Looking for the clinicaltrial.gov identifier on the OP-1 trial for DDD at a single-level, nothing is found to date. There is no magic wand here at this time. BMP-7 (also known as OP-1) stimulates proliferation and Extra Cellular Matrix biosynthesis in nucleus pulposus and annulus fibrosus cells. GDF-5 and TGF-β1 exhibit similar, differing anabolic effects. This is a long dialogue item that I am not qualified to continue.

Overexpression of growth factors and their receptors is a tissue response to disc wounding and degeneration, aimed at the restoration of tissue homeostasis. ProSpec, Protein Specialists, make "laboratory use" growth factors, ... Bone Morphogenic Proteins among other products.



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slackwater_sf