A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” cannot be prepared, shall be exempt from section 502(f)(1) of the act if all the following conditions are met:
(a) The device is:
(1)(i) In the possession of a person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; or
(ii) In the possession of a practitioner, such as physicians, dentists, and veterinarians, licensed by law to use or order the use of such device; and
(2) Is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice.
(b) The label of the device, other than surgical instruments, bears:
(1) The symbol statement “Rx only” or “℞ only” or the statement “Caution: Federal law restricts this device to sale by or on the order of a ___”, the blank to be filled with the word “physician”, “dentist”, “veterinarian”, or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device; and
(2) The method of its application or use.
(c) Labeling on or within the package from which the device is to be dispensed bears information for use, including indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the device can use the device safely and for the purpose for which it is intended, including all purposes for which it is advertised or represented: Provided, however, That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. Upon written request, stating reasonable grounds therefor, the Commissioner will offer an opinion on a proposal to omit such information from the dispensing package under this proviso.
(d) Any labeling, as defined in section 201(m) of the act, whether or not it is on or within a package from which the device is to be dispensed, distributed by or on behalf of the manufacturer, packer, or distributor of the device, that furnishes or purports to furnish information for use of the device contains adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented. This information will not be required on so-called reminder—piece labeling which calls attention to the name of the device but does not include indications or other use information.
(e) All labeling, except labels and cartons, bearing information for use of the device also bears the date of the issuance or the date of the latest revision of such labeling.
[41 FR 6896, Feb. 13, 1976, as amended at 81 FR 38930, June 15, 2016]
Notes of Decisions
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).
· cites it 6× “3d, at 1350-1351 ; 21 CFR § 801.109 (1995). The court made a parallel disposition of the strictliability claims, holding that there was no pre-emption insofar as plaintiffs alleged an unreasonably dangerous design, but they could not revive the negligent manufacturing or failure…”
Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006).
· cites it 4× “” 12 The relevant labeling regulations were set forth in 21 C.F.R. § 801.109 (b) and (c), pursuant to which manufacturers of medical devices must include labeling that “bears information for use, including indications, effects, routes, methods, and frequency and duration of…”
Donna Ellis v. C. R. Bard, Inc., 311 F.3d 1272 (11th Cir. 2002).
· cites it 7× “” However, 21 C.F.R. § 801.109 expressly exempts a prescription device from § 352(f)(1) so long as the device complies with the conditions in 21 C.”
Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015).
· cites it 4× “And for precisely this reason, 21 C.F.R. § 801.109 generally absolves manufacturers from liability under § 352 and § 801.”
Walker v. Johnson & Johnson Vision Prods., Inc, 552 N.W.2d 679 (Mich. Ct. App. 1996).
· cites it 6× “21 CFR 801.109. One of the conditions is that the medical device must be one "for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device.”
Freed v. St. Jude Med., Inc., 364 F. Supp. 3d 343 (D. Del. 2019).
· cites it 2× “Freed of the relevant hazards as mandated by the FDA in various regulations, including 21 C.F.R. §§ 801.109 , 814.39 and 814.82(a)(9).”
Barbara E. Horn, of the Est. of Daniel Ray Horn, Deceased v. Thoratec Corp., 376 F.3d 163 (3rd Cir. 2004).
“198 (1995), and by the FDA labeling regulations requiring devices to carry warnings, 21 C.F.R. § 801.109 (1995), the Lohr plurality stated: the federal requirements [imposed under § 510(k) ] reflect important but entirely generic concerns about device regulation generally, not…”
Tillman v. C.R. Bard, Inc., 96 F. Supp. 3d 1307 (M.D. Fla. 2015).
“Tillman also argues that 21 C.F.R. § 801.109 (c) "imposes a duty on Defendants to warn the patient directly, and breach of this regulation gives rise to strict liability.”
Carealliance Health Servs. v. South Carolina Dep't of Revenue, 787 S.E.2d 475 (S.C. 2016).
· cites it 7× “See 21 C.F.R. § 801.109 (a) (2011) (exempting prescription devices *490 from certain labeling requirements, including when devices “[are] to be sold only to or on the prescription or other order of such practitioner”).”
— 21 C.F.R. § 801.109(a) — 1 case
Carealliance Health Servs. v. South Carolina Dep't of Revenue, 787 S.E.2d 475 (S.C. 2016).
“See 21 C.F.R. § 801.109 (a) (2011) (exempting prescription devices *490 from certain labeling requirements, including when devices “[are] to be sold only to or on the prescription or other order of such practitioner”).”
— 21 C.F.R. § 801.109(b)(1) — 1 case
— 21 C.F.R. § 801.109(c) — 2 cases
Walker v. Johnson & Johnson Vision Prods., Inc, 552 N.W.2d 679 (Mich. Ct. App. 1996).
“21 CFR 801.109. One of the conditions is that the medical device must be one "for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device.”
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