EFTA02431807

To: From: Sent: Subject: Ida [Code of Federal Regulations) [Title 21, Volume 8] [Revised as of April 1, 2009) (CITE: 21CFR1271.10] jeevacation©gmail.com[[email protected]] Thur 1/21/2010 3:18:16 PM TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER L--REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION PART 1271 -- HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Subpart A--General Provisions Sec. 1271.10 Are my HCT/P's regulated solely under section 361 of 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: EFTA_R1_01502303 EFTA02431807 (1) The HCl/P is minimally manipulated; (2) The HCT/P is intended for homologous use only, 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] EFTA_R1_01502304 EFTA02431808 Sincerely, %tits, Wain, M.D. VICTOR DERMATOLOGY AND REJUVENATION LASERSCULPT, INC 30 EAST 76TH STREET 111111 AHelp save paper not printing if not needed EFTA_R1_01502305 EFTA02431809