(a) The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.
(b) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name which may be preceded or followed by the name of the particular division of the corporation. Abbreviations for “Company,” “Incorporated,” etc., may be used and “The” may be omitted. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used.
(c) Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, “Manufactured for ___”, “Distributed by _____”, or any other wording that expresses the facts.
(d) The statement of the place of business shall include the street address, city, State, and Zip Code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP Code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of nonconsumer packages, the ZIP Code shall appear on either the label or the labeling (including the invoice).
(e) If a person manufactures, packs, or distributes a device at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where such device was manufactured or packed or is to be distributed, unless such statement would be misleading.
Notes of Decisions
Joyce A. Moore v. Kimberly-Clark Corp., 867 F.2d 243 (5th Cir. 1989).
· cites it 4× “§ 360k and 21 C.F.R. § 801.1 (b) preempt all state law claims asserted against the manufacturer of the *244 tampons.”
Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015).
· cites it 2× “at 498 -99 (quoting 21 C.F.R. § 801.1 (d)). Put differently, a device must undergo the premarket approval process — or, the Court suggested, perhaps something like it.”
In Re Medtronic, Inc., Implantable Defibrillators, 465 F. Supp. 2d 886 (D. Minnesota 2006).
· cites it 2× “” 21 C.F.R. § 801.1 (d). Because Minnesota, along with most other states, has adopted the UCC implied warranty provision, plaintiffs’ implied warranty claim is not preempted.”
Ellen Mendes v. Medtronic, Inc., 18 F.3d 13 (1st Cir. 1994).
“21 C.F.R. §§ 801.1 , 801.15, 801.109. These regulations, which were in effect when plaintiffs particular pacemaker was implanted, exempt such devices from the requirement that there be directions to a layperson on how to use the product safely, if the package describes, inter…”
Bravman v. Baxter Healthcare Corp., 842 F. Supp. 747 (S.D.N.Y. 1994).
· cites it 2× “1 (d), whether the absence of specific federal counterpart regulations prescribing the design and labeling of heart valves preempts state tort claims, or alternately, whether the fact that a device has received Class III premarket approval classification under the MDA…”
Slater v. Optical Radiation Corp., 756 F. Supp. 370 (N.D. Ill. 1991).
· cites it 3× “6 This is made clear in 21 C.F.R. § 801.1 (d) which provides that: State or local requirements are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device…”
Berger v. Pers. Prods., Inc., 797 P.2d 1148 (Wash. 1990).
· cites it 2× “11 While affirming the District Court's holding that plaintiff's state tort law warnings and instructions claims were preempted, the United States Court of Appeals for the Fifth Circuit reversed the District Court's finding that plaintiff's state tort law design defect claims…”
Spychala v. G.D. Searle & Co., 705 F. Supp. 1024 (D.N.J. 1988).
“21 C.F.R. § 801.1 . Searle argues that, although the Cu-7 had originally been categorized by the FDA as a “new drug,” the Medical Device Amendments included transitional provisions pursuant to which certain devices formerly treated as drugs would be reclassified as “Class III”…”
Zhou v. Desktop Metal, Inc., 120 F. 4th 278 (1st Cir. 2024).
“" 21 C.F.R. § 801.1 (a). It is unlawful to introduce or deliver for introduction into interstate commerce a device that is "misbranded," see 21 U.”
Rosci v. AcroMed, Inc., 669 A.2d 959 (Pa. Super. Ct. 1995).
“, 21 C.F.R. §§ 801.1 , 801.4, 801.5, 801.6, 801.”
Bokis v. Am. Med. Sys., Inc., 875 F. Supp. 748 (W.D. Okla. 1995).
· cites it 2× “, citing 21 C.F.R. §§ 801.1 , 801.15, 801.109. Although the state law standard concerning labeling requirements resembled the federal requirements, the court found the two standards may differ as applied, and a label in compliance with FDA requirements may be found by the…”
— 21 C.F.R. § 801.1(d) — 3 cases
Bravman v. Baxter Healthcare Corp., 842 F. Supp. 747 (S.D.N.Y. 1994).
“1 (d), whether the absence of specific federal counterpart regulations prescribing the design and labeling of heart valves preempts state tort claims, or alternately, whether the fact that a device has received Class III premarket approval classification under the MDA…”
Annotations are extracted automatically from the opinions in the
Syfert caselaw corpus and ranked by authority, recency, and
treatment. Dots show Syfertize treatment of the citing case itself.