1. 38. Id. § 263a(a).
2. 108. See Federal Register 76 (May 19, 2011): 28990; Transcript, CDRH Public Meeting on Ultra High Throughput Sequencing for Clinical Diagnostic Applications – Approaches to Assess Analytical Validity (June 23, 2011), available at (last visited July 8, 2014).
3. 78. Federal Register 62 (November 21, 1997): 62,243, 62,249; see Citizen Petition, FDA Docket 1992P-0405, submitted by Hyxnan, Phelps & McNamara, P.C. (Oct. 22, 1992); See Washington Legal Foundation, “Re: Citizen Petition, available at (last visited April 29, 2014).
4. 52. See generally 21 U.S.C. et seq.
5. 57. Id. § 360c(a)(1)(C).