21 CFR 807.81 - When a premarket notification submission is required
| Cite as | 21 CFR 807.81 |
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149 practice notes
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Riegel v. Medtronic, Inc., Docket No. 04-0412-CV.
..."is about to be significantly Page 113 changed or modified in design, components, method of manufacturer, or intended use," 21 C.F.R. § 807.81(a)(3) (emphasis Having summarized the PMA and § 510(k) routes to market set forth by the MDA, we now move to one final aspect of the MDA t......
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United States ex rel. Colquitt v. Abbott Labs., No. 3:06–cv–1769–M.
...submission, commonly known as a 510(k) notice, before a device may be introduced into interstate commerce. 21 U.S.C. § 360(k); 21 C.F.R. § 807.81 (2010). The 510(k) notice must include, among other things, proposed labeling sufficient to describe the device, its intended use, and the direct......
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Fogal v. Steinfeld
...application to the FDA 90 days before the manufacturer proposes to introduce the device into interstate commerce. [21 U.S.C. § 360(k); 21 C.F.R. § 807.81] In the 1980s 3 a premarket notification for Class III medical devices was required to include all trade, proprietary and common names of......
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United States v. Facteau, Criminal No. 15-cr-10076-ADB
...effective as the predicate device, and that it does not raise different questions of safety or efficacy. See 21 U.S.C. § 360e(b)(1)(B); 21 C.F.R. § 807.81. C. Adulteration and Misbranding Charges The FDCA, 21 U.S.C. § 301 et seq., "was designed primarily to protect consumers from dange......
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67 cases
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Fogal v. Steinfeld
...application to the FDA 90 days before the manufacturer proposes to introduce the device into interstate commerce. [21 U.S.C. § 360(k); 21 C.F.R. § 807.81] In the 1980s 3 a premarket notification for Class III medical devices was required to include all trade, proprietary and common names of......
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United States v. Facteau, Criminal No. 15-cr-10076-ADB
...effective as the predicate device, and that it does not raise different questions of safety or efficacy. See 21 U.S.C. § 360e(b)(1)(B); 21 C.F.R. § 807.81. C. Adulteration and Misbranding Charges The FDCA, 21 U.S.C. § 301 et seq., "was designed primarily to protect consumers from dangerous ......
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Horn v. Thoratec Corp., 02-4597.
...the design and labeling of a Section 510(k)-cleared device as long as it continues to be substantially equivalent to its predicate. 21 C.F.R. § 807.81. In direct contrast to the PMA regime, FDA does not `approve' changes to a Section 510(k)-cleared device. Rather, the manufacturer simply ha......
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National Bank of Commerce of El Dorado v. Kimberly-Clark Corp., KIMBERLY-CLARK
...that it is "substantially equivalent" to an existing Class I or Class II device from the standpoint of safety and effectiveness. See 21 C.F.R. Sec. 807.81. In addition, when a manufacturer modifies a Class I or Class II device already on the market in a way that significantly affects its sa......
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47 firm's commentaries
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In Case of Good Judge, Break Glass – Implied Impossibility Preemption in Cases Involving §510(k) Cleared Medical Devices
...or effectiveness of the device, e.g., a significant change or modification in design, material, [or] chemical composition. . . . 21 C.F.R §807.81(a)(3) (“When a Premarket Notification Submission Is Required”). Pretty much by definition, all device-related changes that could have any causal ......
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FDA Exclusive Enforcement, Lanham Act Division
...modifications to an already cleared device were sufficiently “major” to require the submission of a whole new §510k submission under 21 C.F.R. §807.81(a)(3). Slip op. at 5550-51. Whether the device that the defendant sold was a “major” modification of the device that the FDA had previously ......
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ADHD Software Under FDA Scrutiny
...intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii). As a result, CDRH requested that Pearson immediately cease making these product claims. This recent enforcement action follows a num......
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Time For A Reboot? FDA Issues Draft Guidance On When To Submit A 510(k) For A Software Change To An Existing Device
...to significantly change or modify the design, components, method of manufacturer, or intended use of the device. In particular, 21 C.F.R. § 807.81(a)(3) requires manufacturers to submit a premarket notification to FDA if the "change or modification in the device [] could significantly affec......
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1 books & journal articles
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The Life Sciences Sector
...medical device through its requirements for registering establishments 44. 21 C.F.R. § 860.3(3). 45. 21 C.F.R. § 820.198. 46. 21 C.F.R. § 807.81(a)(3). 47. 21 C.F.R. § 524 CHAPTER 12 and device listing.48Some of the different parties that must register their establishments and list the devi......