21 CFR 807.87 - Information required in a premarket notification submission
| Cite as | 21 CFR 807.87 |
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79 practice notes
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United States ex rel. Colquitt v. Abbott Labs., No. 3:06–cv–1769–M.
...knowledge, that all information in the 510(k) notice is truthful and accurate, and that no material fact has been omitted. 21 C.F.R. § 807.87(e)-(h), (k). Along with the 510(k) notice, a manufacturer must submit a “510(k) summary,” 1 which “shall be in sufficient detail to provide an unders......
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Fogal v. Steinfeld
...of the device; and any additional information requested by the FDA in order to make a substantial equivalency determination. (21 C.F.R. § 807.87) However, the regulations make clear that submission of a premarket notification or a subsequent determination by the FDA that the device is subst......
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Sparks v. Oxy-Health, LLC, No. 5:13–CV–649–FL.
...and effectiveness." Id. When bringing the chamber to market, HTI sought FDA approval through the FDA's 510(k) clearance process. See 21 C.F.R. §§ 807.87, 807.92, 807.93. (describing the requirements for 510(k) clearance). The Supreme Court has described the 510(k) process as a "limited form......
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United States ex rel. Nowak v. Medtronic, Inc., Civil Action Nos. 1:08–cv–10368
...21 C.F.R. § 812.1 et seq. , and “510(k)” clearance based upon prior approval of a substantially equivalent device, 21 U.S.C. § 360; 21 C.F.R. § 807.87(k). To obtain 510(k) clearance to market a device, the manufacturer must submit a premarket notification, including a certified “statement t......
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55 cases
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United States ex rel. Colquitt v. Abbott Labs., No. 3:06–cv–1769–M.
...knowledge, that all information in the 510(k) notice is truthful and accurate, and that no material fact has been omitted. 21 C.F.R. § 807.87(e)-(h), (k). Along with the 510(k) notice, a manufacturer must submit a “510(k) summary,” 1 which “shall be in sufficient detail to provide an unders......
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Fogal v. Steinfeld
...of the device; and any additional information requested by the FDA in order to make a substantial equivalency determination. (21 C.F.R. § 807.87) However, the regulations make clear that submission of a premarket notification or a subsequent determination by the FDA that the device is subst......
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Sparks v. Oxy-Health, LLC, No. 5:13–CV–649–FL.
...and effectiveness." Id. When bringing the chamber to market, HTI sought FDA approval through the FDA's 510(k) clearance process. See 21 C.F.R. §§ 807.87, 807.92, 807.93. (describing the requirements for 510(k) clearance). The Supreme Court has described the 510(k) process as a "limited form......
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United States ex rel. Nowak v. Medtronic, Inc., Civil Action Nos. 1:08–cv–10368
...21 C.F.R. § 812.1 et seq. , and “510(k)” clearance based upon prior approval of a substantially equivalent device, 21 U.S.C. § 360; 21 C.F.R. § 807.87(k). To obtain 510(k) clearance to market a device, the manufacturer must submit a premarket notification, including a certified “statement t......
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1 books & journal articles
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The Life Sciences Sector
...into account an operational quality management system, internal audits, and regulatory inspections that, when read together, tell 52. 21 C.F.R. § 807.87. 53. 21 C.F.R. § 814.20. 54. FDA, Establishment Registration and Device Listing Database, https://www .accessdata.fda.gov/scripts/cdrh/cfd......