21 CFR 860.130 - General procedures under section 513(e) of the act

Cite as21 CFR 860.130
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39 practice notes
4 cases
  • United States ex rel. Modglin v. DJO Global Inc., Case No. CV 12–07152 MMM JCGx.
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Central District of California
    • September 2, 2014
    ...from Class III to Class II in Accordance with Section 513(e) of the Food and Drug Cosmetic Act (FDCA), 21 C.F.R. § 860.123 and 21 C.F.R. § 860.130 ).90 Relators' Supp. RJN, Exh. D (FDA Decision Denying Petition: Orthopedic Devices: Reclassification of Non–Invasive Bone Growth Stimulator).91......
  • United States ex rel. Modglin v. Djo Global Inc., Case No. CV 12–07152 MMM (JCGx).
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Central District of California
    • September 2, 2014
    ...from Class III to Class II in Accordance with Section 513(e) of the Food and Drug Cosmetic Act (FDCA), 21 C.F.R. § 860.123 and 21 C.F.R. § 860.130). 90. Relators' Supp. RJN, Exh. D (FDA Decision Denying Petition: Orthopedic Devices: Reclassification of Non–Invasive Bone Growth Stimulator). ......
  • Ivy Sports Med., LLC v. Burwell, No. 13–5139.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • September 26, 2014
    ...it must be done in accord with certain procedural requirements, including notice and comment. See FDA Br. 36; 21 U.S.C. § 360c(e) ; 21 C.F.R. § 860.130(c).BReGen Biologics, Inc. was a New Jersey-based medical device manufacturer. In 1993, ReGen began research on a new device for use in cert......
  • Ivy Sports Med., LLC v. Burwell, No. 13-5139
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • September 26, 2014
    ...it must be done in accord with certain procedural requirements, including notice and comment. See FDA Br. 36; 21 U.S.C. § 360c(e); 21 C.F.R. § 860.130(c).B ReGen Biologics, Inc. was a New Jersey-based medical device manufacturer. In 1993, ReGen began research on a new device for use in cert......
2 firm's commentaries
  • FDA Proposal Amends Medical Device Classification Rules
    • United States
    • Mondaq United States
    • April 3, 2014
    ...to answer the classification questionnaire and provide information using the supplemental data sheet. Revise the procedure at 21 CFR § 860.130 to reflect the FDASIA requirement that devices reclassified under 513(e) of the Food, Drug and Cosmetic Act be reclassified using an administrative ......
  • FDA Proposal Amends Medical Device Classification Rules
    • United States
    • LexBlog United States
    • April 2, 2014
    ...to answer the classification questionnaire and provide information using the supplemental data sheet. Revise the procedure at 21 CFR § 860.130 to reflect the FDASIA requirement that devices reclassified under 513(e) of the Food, Drug and Cosmetic Act be reclassified using an administrative ......

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