21 U.S.C. § 360h

Notification and other remedies

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(a) NotificationIf the Secretary determines that—(1) a device intended for human use which is introduced or delivered for introduction into interstate commerce for commercial distribution presents an unreasonable risk of substantial harm to the public health, and(2) notification under this subsection is necessary to eliminate the unreasonable risk of such harm and no more practicable means is available under the provisions of this chapter (other than this section) to eliminate such risk,the Secretary may issue such order as may be necessary to assure that adequate notification is provided in an appropriate form, by the persons and means best suited under the circumstances involved, to all health professionals who prescribe or use the device and to any other person (including manufacturers, importers, distributors, retailers, and device users) who should properly receive such notification in order to eliminate such risk. An order under this subsection shall require that the individuals subject to the risk with respect to which the order is to be issued be included in the persons to be notified of the risk unless the Secretary determines that notice to such individuals would present a greater danger to the health of such individuals than no such notification. If the Secretary makes such a determination with respect to such individuals, the order shall require that the health professionals who prescribe or use the device provide for the notification of the individuals whom the health professionals treated with the device of the risk presented by the device and of any action which may be taken by or on behalf of such individuals to eliminate or reduce such risk. Before issuing an order under this subsection, the Secretary shall consult with the persons who are to give notice under the order.(b) Repair, replacement, or refund(1)(A) If, after affording opportunity for an informal hearing, the Secretary determines that—(i) a device intended for human use which is introduced or delivered for introduction into interstate commerce for commercial distribution presents an unreasonable risk of substantial harm to the public health,(ii) there are reasonable grounds to believe that the device was not properly designed or manufactured with reference to the state of the art as it existed at the time of its design or manufacture,(iii) there are reasonable grounds to believe that the unreasonable risk was not caused by failure of a person other than a manufacturer, importer, distributor, or retailer of the device to exercise due care in the installation, maintenance, repair, or use of the device, and(iv) the notification authorized by subsection (a) would not by itself be sufficient to eliminate the unreasonable risk and action described in paragraph (2) of this subsection is necessary to eliminate such risk,the Secretary may order the manufacturer, importer, or any distributor of such device, or any combination of such persons, to submit to him within a reasonable time a plan for taking one or more of the actions described in paragraph (2). An order issued under the preceding sentence which is directed to more than one person shall specify which person may decide which action shall be taken under such plan and the person specified shall be the person who the Secretary determines bears the principal, ultimate financial responsibility for action taken under the plan unless the Secretary cannot determine who bears such responsibility or the Secretary determines that the protection of the public health requires that such decision be made by a person (including a device user or health professional) other than the person he determines bears such responsibility.(B) The Secretary shall approve a plan submitted pursuant to an order issued under subparagraph (A) unless he determines (after affording opportunity for an informal hearing) that the action or actions to be taken under the plan or the manner in which such action or actions are to be taken under the plan will not assure that the unreasonable risk with respect to which such order was issued will be eliminated. If the Secretary disapproves a plan, he shall order a revised plan to be submitted to him within a reasonable time. If the Secretary determines (after affording opportunity for an informal hearing) that the revised plan is unsatisfactory or if no revised plan or no initial plan has been submitted to the Secretary within the prescribed time, the Secretary shall (i) prescribe a plan to be carried out by the person or persons to whom the order issued under subparagraph (A) was directed, or (ii) after affording an opportunity for an informal hearing, by order prescribe a plan to be carried out by a person who is a manufacturer, importer, distributor, or retailer of the device with respect to which the order was issued but to whom the order under subparagraph (A) was not directed.(2) The actions which may be taken under a plan submitted under an order issued under paragraph (1) are as follows:(A) To repair the device so that it does not present the unreasonable risk of substantial harm with respect to which the order under paragraph (1) was issued.(B) To replace the device with a like or equivalent device which is in conformity with all applicable requirements of this chapter.(C) To refund the purchase price of the device (less a reasonable allowance for use if such device has been in the possession of the device user for one year or more—(i) at the time of notification ordered under subsection (a), or(ii) at the time the device user receives actual notice of the unreasonable risk with respect to which the order was issued under paragraph (1),whichever first occurs).(3) No charge shall be made to any person (other than a manufacturer, importer, distributor or retailer) for availing himself of any remedy, described in paragraph (2) and provided under an order issued under paragraph (1), and the person subject to the order shall reimburse each person (other than a manufacturer, importer, distributor, or retailer) who is entitled to such a remedy for any reasonable and foreseeable expenses actually incurred by such person in availing himself of such remedy.(c) Reimbursement

An order issued under subsection (b) with respect to a device may require any person who is a manufacturer, importer, distributor, or retailer of the device to reimburse any other person who is a manufacturer, importer, distributor, or retailer of such device for such other person’s expenses actually incurred in connection with carrying out the order if the Secretary determines such reimbursement is required for the protection of the public health. Any such requirement shall not affect any rights or obligations under any contract to which the person receiving reimbursement or the person making such reimbursement is a party.

(d) Effect on other liability

Compliance with an order issued under this section shall not relieve any person from liability under Federal or State law. In awarding damages for economic loss in an action brought for the enforcement of any such liability, the value to the plaintiff in such action of any remedy provided him under such order shall be taken into account.

(e) Recall authority(1) If the Secretary finds that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the device)—(A) to immediately cease distribution of such device, and(B) to immediately notify health professionals and device user facilities of the order and to instruct such professionals and facilities to cease use of such device.The order shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of the issuance of the order, on the actions required by the order and on whether the order should be amended to require a recall of such device. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order.(2)(A) If, after providing an opportunity for an informal hearing under paragraph (1), the Secretary determines that the order should be amended to include a recall of the device with respect to which the order was issued, the Secretary shall, except as provided in subparagraphs (B) and (C), amend the order to require a recall. The Secretary shall specify a timetable in which the device recall will occur and shall require periodic reports to the Secretary describing the progress of the recall.(B) An amended order under subparagraph (A)—(i) shall—(I) not include recall of a device from individuals, and(II) not include recall of a device from device user facilities if the Secretary determines that the risk of recalling such device from the facilities presents a greater health risk than the health risk of not recalling the device from use, and(ii) shall provide for notice to individuals subject to the risks associated with the use of such device.In providing the notice required by clause (ii), the Secretary may use the assistance of health professionals who prescribed or used such a device for individuals. If a significant number of such individuals cannot be identified, the Secretary shall notify such individuals pursuant to section 375(b) of this title.(3) The remedy provided by this subsection shall be in addition to remedies provided by subsections (a), (b), and (c).(June 25, 1938, ch. 675, § 518, as added Pub. L. 94–295, § 2, May 28, 1976, 90 Stat. 562; amended Pub. L. 101–629, § 8, Nov. 28, 1990, 104 Stat. 4520; Pub. L. 102–300, § 4, June 16, 1992, 106 Stat. 239.)Editorial NotesAmendments

1992—Subsec. (b)(1)(A)(ii). Pub. L. 102–300 substituted “or” for “and” after “properly designed” and “time of its design”.

1990—Subsec. (e). Pub. L. 101–629 added subsec. (e).

Notes of Decisions

Cited in 49 cases (3 in the last 5 years), 1982–2025 · leading case: Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000).

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Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000). · cites it 4× “21 U. S. C. § 360h(e)(1) (emphasis added).”

Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). · cites it 2× “" 21 U.S.C. § 360h(b)(1)(A). Thus the FDA may order the manufacturer to repair the device, replace it, refund the purchase price, cease distribution, or recall the device.”

Nina Michael v. Shiley, Inc. Hosp. Prods. Grp., Inc., (Formerly Howmedica, Inc.) Pfizer, Inc, 46 F.3d 1316 (3rd Cir. 1995). · cites it 4× “Section 360h(d) defines the effect that a manufacturer’s compliance with an *1327 FDA notification, reimbursement, or recall order should have: Compliance with an order issued under this section shall not reheve any person of liability under Federal or State law.”

Talbott v. C.R. Bard, Inc., 865 F. Supp. 37 (D. Mass. 1994). · cites it 5× “As a practical matter, if Congress intended to establish a fraud on the FDA exception to the preemption it provided for state law claims concerning Class III devices, which are comprehensively regulated by the FDA, it would have seriously threatened the balance it sought to…”

Blunt v. Medtronic, Inc., 2009 WI 16 (Wis. 2009). · cites it 4× “§ 360e(e)(1); 21 U.S.C. § 360h(e). As the Supreme Court noted: [t]he FDA has the power to withdraw premarket approval based on newly reported data or existing information and must withdraw approval if it determines that a device is unsafe or ineffective under the conditions in…”

Barbara Mitchell & Gregory Mitchell v. Collagen Corp., 67 F.3d 1268 (7th Cir. 1995). · cites it 4× “21 U.S.C. § 360h(d). The Mitchells submit that this portion of the MDA “saves” all common law causes of action from preemption.”

Gross v. Stryker Corp., 858 F. Supp. 2d 466 (W.D. Pa. 2012). · cites it 2× “§ 360e(e)(1); 21 U.S.C. § 360h(e)). The majority of Class III devices do not undergo this intensive PMA review.”

Stengel v. Medtronic, Inc., 676 F.3d 1159 (9th Cir. 2012). · cites it 4× “See 21 U.S.C. § 360h(a). This is precisely the same theory that was rejected in Buckman.”

Jack McMullen & Barbara McMullen v. Medtronic, Inc., 421 F.3d 482 (7th Cir. 2005). “” Sections 518(a) and (e) of the MDA, codified at 21 U.S.C. §§ 360h(a) and (e), give the Secretary of Health and Human Services the discretion to issue or withhold warnings concerning medical devices based on the Secretary’s assessment of the risks, and to issue recall orders…”

prod.liab.rep. (Cch) P 14,260 Lora Lohr, Michael Lohr, Her Husband v. Medtronic, Inc., a Foreign Corp., 56 F.3d 1335 (11th Cir. 1995). · cites it 2× “” 21 U.S.C.A. § 360h(d). While the savings clause almost certainly prohibits a holding that the MDA preempts all state law liability, our interpretation of § 360k(a) does not preclude all liability.”

Walker v. Johnson & Johnson Vision Prods., Inc, 552 N.W.2d 679 (Mich. Ct. App. 1996). · cites it 2× “" 21 U.S.C. § 360h(d). Congress' inclusion of such a provision in the MDA is evidence that Congress intended to preserve state products liability claims against manufacturers of Class III medical devices rather than to preempt such claims.”

Mulligan v. Pfizer Inc., 850 F. Supp. 633 (S.D. Ohio 1994). · cites it 3× “21 U.S.C. § 360h(b)(l)(A). Subparagraph (2) discusses the procedure for repair or replacement, and section (c) addresses reimbursement.”

Show all 49 citing cases →

— 21 U.S.C. § 360h(a) — 13 cases

Nina Michael v. Shiley, Inc. Hosp. Prods. Grp., Inc., (Formerly Howmedica, Inc.) Pfizer, Inc, 46 F.3d 1316 (3rd Cir. 1995). “Section 360h(d) defines the effect that a manufacturer’s compliance with an *1327 FDA notification, reimbursement, or recall order should have: Compliance with an order issued under this section shall not reheve any person of liability under Federal or State law.”

Stengel v. Medtronic, Inc., 676 F.3d 1159 (9th Cir. 2012). “See 21 U.S.C. § 360h(a). This is precisely the same theory that was rejected in Buckman.”

Ethel Cupek v. Medtronic, Inc., 405 F.3d 421 (6th Cir. 2005).

Worthy v. Collagen Corp., 967 S.W.2d 360 (Tex. 1998).

— 21 U.S.C. § 360h(a)(2) — 1 case

Gates v. Medtronic, Inc., 192 F. Supp. 3d 704 (W.D. Tex. 2016).

— 21 U.S.C. § 360h(b) — 2 cases

Haidak v. Collagen Corp., 67 F. Supp. 2d 21 (D. Mass. 1999).

Ass'n for Molecular Pathology v. United States Food & Drug Admin. PURSUANT TO COURT ORDER, DOCKET IN THE LEAD CASE AS DIRECTED. (E.D. Tex. 2025).

— 21 U.S.C. § 360h(b)(1)(A) — 1 case

Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). “" 21 U.S.C. § 360h(b)(1)(A). Thus the FDA may order the manufacturer to repair the device, replace it, refund the purchase price, cease distribution, or recall the device.”

— 21 U.S.C. § 360h(b)(2)(C) — 2 cases

United States v. Lane Labs-Usa Inc, a Corp. Andrew J. Lane, an Individual, 427 F.3d 219 (3rd Cir. 2005).

United States v. Lane Labs-USA Inc (3rd Cir. 2005).

— 21 U.S.C. § 360h(b)(l)(A) — 2 cases

Mulligan v. Pfizer Inc., 850 F. Supp. 633 (S.D. Ohio 1994). “21 U.S.C. § 360h(b)(l)(A). Subparagraph (2) discusses the procedure for repair or replacement, and section (c) addresses reimbursement.”

— 21 U.S.C. § 360h(c) — 1 case

Haidak v. Collagen Corp., 67 F. Supp. 2d 21 (D. Mass. 1999).

— 21 U.S.C. § 360h(d) — 15 cases

Talbott v. C.R. Bard, Inc., 865 F. Supp. 37 (D. Mass. 1994). “As a practical matter, if Congress intended to establish a fraud on the FDA exception to the preemption it provided for state law claims concerning Class III devices, which are comprehensively regulated by the FDA, it would have seriously threatened the balance it sought to…”

Barbara Mitchell & Gregory Mitchell v. Collagen Corp., 67 F.3d 1268 (7th Cir. 1995). “21 U.S.C. § 360h(d). The Mitchells submit that this portion of the MDA “saves” all common law causes of action from preemption.”

prod.liab.rep. (Cch) P 14,260 Lora Lohr, Michael Lohr, Her Husband v. Medtronic, Inc., a Foreign Corp., 56 F.3d 1335 (11th Cir. 1995). “” 21 U.S.C.A. § 360h(d). While the savings clause almost certainly prohibits a holding that the MDA preempts all state law liability, our interpretation of § 360k(a) does not preclude all liability.”

Walker v. Johnson & Johnson Vision Prods., Inc, 552 N.W.2d 679 (Mich. Ct. App. 1996). “" 21 U.S.C. § 360h(d). Congress' inclusion of such a provision in the MDA is evidence that Congress intended to preserve state products liability claims against manufacturers of Class III medical devices rather than to preempt such claims.”

Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th Cir. 1999).

— 21 U.S.C. § 360h(e) — 2 cases

Blunt v. Medtronic, Inc., 2009 WI 16 (Wis. 2009). “§ 360e(e)(1); 21 U.S.C. § 360h(e). As the Supreme Court noted: [t]he FDA has the power to withdraw premarket approval based on newly reported data or existing information and must withdraw approval if it determines that a device is unsafe or ineffective under the conditions in…”

Gross v. Stryker Corp., 858 F. Supp. 2d 466 (W.D. Pa. 2012). “§ 360e(e)(1); 21 U.S.C. § 360h(e)). The majority of Class III devices do not undergo this intensive PMA review.”

— 21 U.S.C. § 360h(e)(1) — 6 cases

Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000). “21 U. S. C. § 360h(e)(1) (emphasis added).”

Gross v. Stryker Corp., 858 F. Supp. 2d 466 (W.D. Pa. 2012). “§ 360e(e)(1); 21 U.S.C. § 360h(e)). The majority of Class III devices do not undergo this intensive PMA review.”

Blunt v. Medtronic, Inc., 2007 WI App 191 (Wis. Ct. App. 2007).

Milanesi v. C.R. Bard, Inc. (S.D. Ohio 2021).

— 21 U.S.C. § 360h(e)(1)(A) — 1 case

Brown & Williamson v. FDA (4th Cir. 2000).

— 21 U.S.C. § 360h(e)(2) — 2 cases

Gates v. Medtronic, Inc., 192 F. Supp. 3d 704 (W.D. Tex. 2016).

Brown & Williamson v. FDA (4th Cir. 2000).

— 21 U.S.C. § 360h(e)(2)(B)(i) — 1 case

Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000). “21 U. S. C. § 360h(e)(1) (emphasis added).”

— 21 U.S.C. § 360h(e)(l) — 6 cases

Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000). “21 U. S. C. § 360h(e)(1) (emphasis added).”

In re Telectronics Pacing Sys., Inc., 168 F.R.D. 203 (S.D. Ohio 1996).

In re Telectronics Pacing Sys., Inc., 164 F.R.D. 222 (S.D. Ohio 1995).

Blunt v. Medtronic, Inc., 2007 WI App 191 (Wis. Ct. App. 2007).

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