(a) This part implements section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment, amendment, and revocation of performance standards applicable to devices intended for human use.
(b) The Food and Drug Administration may determine that a performance standard, as described under special controls for class II devices in § 860.7(b) of this chapter, is necessary to provide reasonable assurance of the safety and effectiveness of the device. Performance standards may be established for:
(1) A class II device;
(2) A class III device which, upon the effective date of the standard, is reclassified into class II; and
(3) A class III device, as a condition to premarket approval under section 515 of the act, to reduce or eliminate a risk or risks associated with such device.
(c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.
[45 FR 7484, Feb. 1, 1980, as amended at 45 FR 23686, Apr. 8, 1980; 57 FR 58404, Dec. 10, 1992]
Notes of Decisions
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).
· cites it 2× “It may also condition approval on adherence to performance standards, 21 CFR § 861.1 (b)(3), restrictions upon sale or distribution, or compliance with other requirements, § 814.”
Sherry Walker v. Medtronic, Inc., 670 F.3d 569 (4th Cir. 2012).
· cites it 4× “21 C.F.R. § 861.1 (b)(3). Once premarket approval has been granted, "the MDA for- bids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing process, labeling, or any other attribute, that would affect safety or effectiveness.”
Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006).
· cites it 2× “Alternatively, as the dissent points out, the FDA could also have deemed it appropriate to promulgate performance standards applicable to catheters such as the Evergreen Balloon Catheter, pursuant to 21 C.F.R. § 861.1 (b)(3). Post at 132. Apparently, however, the FDA concluded…”
Barbara Kaiser v. Johnson & Johnson, 947 F.3d 996 (7th Cir. 2020).
“See 21 C.F.R. § 861.1 (b) (permitting the FDA to set performance standards for Class II and III devices); see also Nicholas R.”
Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206 (W.D. Okla. 2013).
“It may also condition approval on adherence to performance standards, 21 CFR § 861.1 (b)(3), restrictions upon sale or distribution, or compliance with other requirements, § 814.”
Glennen v. Allergan, Inc., 247 Cal. App. 4th 1 (Cal. Ct. App. 2016).
“) The FDA has broad authority to condition its approval in a number of ways, including requiring that the device meet formal performance standards ( 21 C.F.R. § 861.1 (b)(3) (2016)), or any other postapproval requirement “necessary to provide reasonable assurance, or continued…”
Hafer v. Medtronic, Inc., 99 F. Supp. 3d 844 (W.D. Tenn. 2015).
“Once it has completed its review and grants PMA approval, the FDA “may also condition approval on adherence to performance standards, 21 CFR § 861.1 (b)(3), restrictions upon sale or distribution, or compliance with other requirements, § 814.”
Byrnes v. Small, 60 F. Supp. 3d 1289 (M.D. Fla. 2015).
“Even after PMA approval is granted, manufacturers are forbidden to make changes in design specifications, manufacturing processes, labeling, or any other attribute that would affect safety or effectiveness, without FDA permission.”
McClelland v. Medtronic, Inc., 944 F. Supp. 2d 1193 (M.D. Fla. 2013).
“Even after PMA is granted, manufacturers are forbidden to make changes in design specifications, manufacturing processes, labeling, or any other attribute that would affect safety or effectiveness, without FDA permission.”
Raab v. Smith & Nephew, Inc., 150 F. Supp. 3d 671 (S.D.W. Va 2015).
“The FDA has broad authority to condition its approval in a number' of ways, including requiring that the device meet formal performance standards, 21 C.F.R. § 861.1 (b)(3), or any other post-approval requirement “necessary to provide reasonable assurance, or continued reasonable…”
James v. Diva Int'l, Inc., 803 F. Supp. 2d 945 (S.D. Ind. 2011).
“Defendant argues that the DivaCup® is subject to the performance standards developed pursuant to 21 C.F.R. § 861.1 et seq. and that under 21 C.”
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