[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.20]

[Page 672]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 1271.20  If my HCT/P's do not meet the criteria in Sec. 1271.10, and I do not qualify for any of the exceptions in Sec. 1271.15, what regulations apply?

    If you are an establishment that manufactures an HCT/P that does not 
meet the criteria set out in Sec. 1271.10(a), and you do not qualify for 
any of the exceptions in Sec. 1271.15, your HCT/P will be regulated as a 
drug, device, and/or biological product under the act and/or section 351 
of the PHS Act, and applicable regulations in title 21, chapter I. 
Applicable regulations include, but are not limited to, Secs. 207.20(f), 
210.1(c), 210.2, 211.1(b), 807.20(d), and 820.1(a) of this chapter, 
which require you to follow the procedures in subparts B, C, and D of 
this part.