To: jeevacation@gmail.com[jeevacation@gmail.com]
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Sent: Thur 1/21/2010 3:18:16 PM

Subject: Ida

[Code of Federal Regulations)

[Title 21, Volume 8]

[Revised as of April 1, 2009)

[CITE: 21CFR1271.10]

## TITLE 21--FOOD AND DRUGS

# CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES

# CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES (cont.)

## SUBCHAPTER L--REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION

# CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES (cont.)

## <u>PART 1271 -- HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS</u> 

Subpart A--General Provisions

Sec. 1271.10 Are my HCT/P's regulated solely under section 361of the PHS Act and the regulations in this part, and if so what must I do?

(a) An HCT/P is regulated solely under section 361 of the PHS Act and the regulations in this part if it meets all of the following criteria:

# CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES (cont.)

## <u>PART 1271 -- HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS</u>  (cont.)

# CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES (cont.)

## (1) <mark>The HCl/P isminimally manipulated;</mark>

<mark>(2) The HCT/P is intended for homologous use only,</mark> as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent;

(3) The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and

(4) Either:

(i) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or

(ii) The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:

(a ) Is for autologous use;

	) Is for allogeneic use in a first-degree or second-degree blood relative; or

(c ) Is for reproductive use.

(b) If you are a domestic or foreign establishment that manufactures an HCT/P described in paragraph (a) of this section:

(1) You must register with FDA;

(2) You must submit to FDA a list of each HCT/P manufactured; and

(3) You must comply with the other requirements contained in this part.

[66 FR 5466, Jan. 19, 2001, as amended at 69 FR 68681, Nov. 24, 2004]

[Code of

Federal

Regulations]

# CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES (cont.)

## (1) <mark>The HCl/P isminimally manipulated;</mark> (cont.)

Sincerely,

Steven Victor, M.D.

VICTOR DERMATOLOGY AND REJUVENATION
LASERSCULPT, INC
30 EAST 76TH STREET

NEW YORK NEW YORK 10021

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