21 C.F.R. §807.87 - Information required in a premarket notification submission
| Cite as | 21 C.F.R. §807.87 |
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55 cases
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Burgstahler v. AcroMed Corp.
...a device which was grandfathered into the market by virtue of having been first sold prior to May 28, 1976. 21 U.S.C. § 360e(b)(1)(B); 21 C.F.R. § 807.87. The manufacturer must submit a Premarket Notification (PMN), also known as a 510(k) notification, which includes specified information 9......
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National Bank of Commerce of El Dorado v. Kimberly-Clark Corp., KIMBERLY-CLARK
...its proposed labeling to the FDA, which it must do under Sec. 510(k) of the Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 360(k)) and 21 C.F.R. Sec. 807.87(e) to receive permission to market, the FDA asked that certain changes be made. Id. at 144-45. Kimberly-Clark made those changes, resubm......
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Kubicki ex rel. Kubicki v. Medtronic, Inc., Civil No. 12–cv–734 (KBJ)
...devices to which the new device is substantially equivalent, and offers a 293 F.Supp.3d 170proposed classification." Id. at 83 (citing 21 C.F.R. § 807.87 ).It is important to recognize that "[t]he § 510(k) notification process is by no means comparable to the PMA process; in contrast to the......
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United States v. Medtronic, Inc., CIVIL ACTION NOS. 1:09-cv-11625
...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......