21 CFR 860.130 - General procedures under section 513(e) of the act
| Cite as | 21 CFR 860.130 |
-
- This document is available in original version only for vLex customers
View this document and try vLex for 7 days - TRY VLEX
- This document is available in original version only for vLex customers
39 practice notes
-
United States ex rel. Modglin v. DJO Global Inc., Case No. CV 12–07152 MMM JCGx.
...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).
...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.
...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......
-
Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression
...been previously cleared by FDA in 510(k)s. Therefore, in accordance with sections 513(e) and 515(i) of the FD&C Act and Sec. 860.130 (21 CFR 860.130), based on new information with respect to the devices and taking into account the public health benefit of the use of the device and the ......
Request a trial to view additional results
4 cases
-
United States ex rel. Modglin v. DJO Global Inc., Case No. CV 12–07152 MMM JCGx.
...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).
...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.
...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
...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
...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
...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 ......