21 CFR 814.80 - General
| Cite as | 21 CFR 814.80 |
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111 practice notes
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Blanco v. Baxter Healthcare Corp., No. G038255.
...specifications may be changed in [a] way that affects safety and effectiveness only with FDA's authorization"]; see also 21 C.F.R. §§ 814.39, 814.80, 814.82, 814.84.) The PMA process has been described as "rigorous," requiring "[manufacturers [to] submit detailed information regarding the s......
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Hawkins v. Medtronic, Inc., Case No. 1:13–CV–00499 AWI SKO.
...‘misbranding’ of medical devices, which includes either misleading labeling or misleading advertising of the medical device, and 21 C.F.R. § 814.80 prohibits Defendants from advertising the INFUSE® Device for uses beyond what is provided in the PMA approval)2 ; Hawkins, 2014 WL 346622 at *7......
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Mears v. Marshall
...or advertise the device "in a manner inconsistent with any conditions to approval specified in the PMA approval order for the device." 21 CFR § 814.80. With only minor exceptions, the manufacturer must also submit a PMA supplement for FDA review and approval before making changes that affec......
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McLaughlin v. Bayer Corp., CIVIL ACTION NOS. 14-7315
...prohibit a device from being labeled, advertised, or distributed in a manner inconsistent with any condition of approval in the PMA. See21 C.F.R. 814.80 (prohibiting a device from being labeled, advertised, or distributed in a manner inconsistent with any condition of approval in the PMA). ......
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112 cases
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Blanco v. Baxter Healthcare Corp., No. G038255.
...specifications may be changed in [a] way that affects safety and effectiveness only with FDA's authorization"]; see also 21 C.F.R. §§ 814.39, 814.80, 814.82, 814.84.) The PMA process has been described as "rigorous," requiring "[manufacturers [to] submit detailed information regarding the s......
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Hawkins v. Medtronic, Inc., Case No. 1:13–CV–00499 AWI SKO.
...‘misbranding’ of medical devices, which includes either misleading labeling or misleading advertising of the medical device, and 21 C.F.R. § 814.80 prohibits Defendants from advertising the INFUSE® Device for uses beyond what is provided in the PMA approval)2 ; Hawkins, 2014 WL 346622 at *7......
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Mears v. Marshall
...or advertise the device "in a manner inconsistent with any conditions to approval specified in the PMA approval order for the device." 21 CFR § 814.80. With only minor exceptions, the manufacturer must also submit a PMA supplement for FDA review and approval before making changes that affec......
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McLaughlin v. Bayer Corp., CIVIL ACTION NOS. 14-7315
...prohibit a device from being labeled, advertised, or distributed in a manner inconsistent with any condition of approval in the PMA. See21 C.F.R. 814.80 (prohibiting a device from being labeled, advertised, or distributed in a manner inconsistent with any condition of approval in the PMA). ......
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