§862.1164. Setmelanotide eligibility gene variant detection system. — Inbound Citations
21 C.F.R. § 862.1164
Statutory Authority
Cited by 4 regulations in release Current.
Citations to §862.1164(b)(1)(i)
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(v) Detailed documentation of studies that provide data demonstrating adequate, as determined by FDA, stability of the specimens used in the design validation studies in paragraphs (b)(1)(i) through (iv) of this section, as applicable.
Citations to §862.1164(b)(1)(ii)
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(v) Detailed documentation of studies that provide data demonstrating adequate, as determined by FDA, stability of the specimens used in the design validation studies in paragraphs (b)(1)(i) through (iv) of this section, as applicable.
Citations to §862.1164(b)(1)(iii)
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(v) Detailed documentation of studies that provide data demonstrating adequate, as determined by FDA, stability of the specimens used in the design validation studies in paragraphs (b)(1)(i) through (iv) of this section, as applicable.
Citations to §862.1164(b)(1)(iv)
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(v) Detailed documentation of studies that provide data demonstrating adequate, as determined by FDA, stability of the specimens used in the design validation studies in paragraphs (b)(1)(i) through (iv) of this section, as applicable.