Deborah M. Autor
Office of Consumer Litigation
Summary of Bases for Charges:
Cases against individuals or firms involved in the manufacture or distribution of medical devices are usually rooted in allegations that the devices are "adulterated" or "misbranded" under the Federal Food, Drug, and Cosmetic Act (the "FDCA"). A device may be adulterated or misbranded for a number of reasons. A device may be adulterated, for example, if it was not manufactured in accordance with the required manufacturing standards ("good manufacturing practice"), FDCA § 501(h), 21 U.S.C. § 351(h); FDCA § 520(f), 21 U.S.C. § 360j(f); 21 C.F.R. part 820, or if it does not have the quality that it purports to possess, FDCA § 501(c), 21 U.S.C. § 351(c). Examples of causes of misbranding of a device include that its labeling is false or misleading, FDCA § 502(a), 21 U.S.C. § 352(a), or that it is an over-the-counter (i.e., non-prescription) device that does not bear adequate directions for the consumer to be able to use it, FDCA § 502(f), 21 U.S.C. § 352(f); 21 C.F.R. § 801.109. A device may also be adulterated or misbranded because it lacks requisite FDA clearance or approval. See FDCA §§ 501(f), 502(o), 21 U.S.C. §§ 351(f), 352(o).
The FDCA prohibits the doing of a number of acts with respect to a medical device that is adulterated or misbranded, such as introducing it into interstate commerce, see FDCA § 301(a), 21 U.S.C. § 331(a), or holding the device for sale after shipment of the device itself or a component of the device in interstate commerce, see FDCA § 301(k), 21 U.S.C. § 331(k); see also FDCA § 303, 21 U.S.C. § 333 (penalties); FDCA § 709, 21 U.S.C. § 379a (presumption of interstate commerce for medical devices).
The definition of medical device includes everything from toothbrushes to x-ray cameras. A medical device is:
an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is -
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
FDCA § 201(h), 21 U.S.C. § 321(h).
Note that the definition of "device" is quite similar to the definition of "drug." The key distinction is that devices do not work primarily through chemical action or by being metabolized.
Device Clearances or Approvals:
As explained below, it is not always necessary to get FDA's permission before marketing a medical device. But, if FDA's permission is needed, it is acquired through one of two possible mechanisms - a 510(k) or a Premarket Approval Application ("PMA").
510(k)s - A 510(k) (named for the relevant provision of the FDCA, FDCA § 510(k), 21 U.S.C. § 360(k), and also known as a premarket notification or PMN) is by far the more common of the two mechanisms. As compared to PMAs, 510(k)s are generally much shorter, reviewed more quickly, and, unlike PMAs, do not usually contain clinical data. Increasingly, however, 510(k)s are becoming lengthier, more complex submissions, and at times are including clinical data.
In "clearing" a 510(k), FDA makes a finding that the new device is "substantially equivalent" to a "predicate" device.
A "predicate" is a device that was legally marketed before May 28, 1976 (the effective date of the Medical Device Amendments of 1976) and that is not required to have a PMA, a device that has been classified into Class I or Class II (see below), or any device that is covered by a cleared 510(k). See FDCA § 513(f)(1), 21 U.S.C. § 360c(f)(1).
"Substantially equivalent" means that the new device has the same intended use and the same technological characteristics as the predicate device, or it has the same intended use and different technological characteristics, but the information submitted in the 510(k) demonstrates that the new device is as safe and effective as the predicate and does not raise different questions regarding safety and effectiveness than the predicate. FDCA § 513(i)(1)(A), 21 U.S.C. § 360c(i)(1)(A); see also 21 C.F.R. § 807.100(b).
PMAs - A PMA is analogous to an NDA for a new drug. PMAs are far more complex than 510(k)s, because in order to obtain FDA approval of a PMA the sponsor must provide FDA with a reasonable assurance that the device is safe and effective for its intended use. FDCA § 515(d)(2), 21 U.S.C. § 360e(d)(2); see generally 21 C.F.R. part 814. A PMA will usually include the results of extensive clinical studies, and may be in the FDA review process for a period of years.
In approving a PMA, FDA can (and often does) impose conditions on a device or its manufacturer. FDCA § 515(d)(1)(B)(ii), 21 U.S.C. § 360e(d)(1)(B)(ii); see also 21 C.F.R. § 814.82(a). For example, FDA may require that a device be restricted to prescription use. See FDCA §§ 515(d)(1)(B)(ii), 520(e), 21 U.S.C. §§ 360e(d)(1)(B)(ii), 360j(e). (Note that FDA can also impose restrictions on devices by means of a regulation. See FDCA § 520(e), 21 U.S.C. § 360j(e).)
Lack of Necessary Clearance or Approval - The failure to submit a required 510(k) is a prohibited act, and the lack of a necessary 510(k) renders a device misbranded. See FDCA §§ 301(p), 502(o), 21 U.S.C. §§ 331(p), 352(o). A device that lacks a necessary PMA is adulterated. FDCA § 501(f), 21 U.S.C. § 351(f). Note, however, that every new device that lacks a necessary 510(k) is considered by operation of law to be a Class III device that needs a PMA, and therefore until that device has a 510(k), it is also adulterated. See FDCA §§ 513(f)(1), 501(f)(1)(B)(i), 21 U.S.C. §§ 360c(f)(1), 351(f)(1)(B)(i).
Modifications of Already Cleared or Approved Devices:
For "510(k)ed" devices, a new 510(k) is required if the device is "about to be significantly changed or modified in design, components, method of manufacture, or intended use." 21 C.F.R. § 807.81(a)(3). The regulations specify the following as significant changes or modifications that require a 510(k): (1) a change or modification of the device that could significantly affect the safety or effectiveness of the device; or (2) a major change or modification in the intended use of the device. Id.
For "PMAed" devices, the manufacturer is required to submit a supplement to its PMA before making a change "affecting the safety or effectiveness" of the device. 21 C.F.R. § 814.39(a).
The consequences of a failure to submit a necessary 510(k) or a necessary PMA supplement for a change to a device are the same as those for failing to make any necessary 510(k) or PMA submission (see above).
General Device-Related Obligations:
Registration and Listing - With certain exceptions, an owner or operator of an establishment engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a medical device is required to register with FDA and to "list" its products with FDA by providing certain information about those products. See FDCA §§ 510(a)-(j), 21 U.S.C. §§ 360(a)-(j); see also 21 C.F.R. part 807. A device that was manufactured, prepared, etc. in an establishment that is not duly registered, or that is not listed as required by 510(j), is misbranded. FDCA § 502(o), 21 U.S.C. § 352(o). In addition, the failure to register or to list is a prohibited act. FDCA § 301(p), 21 U.S.C. § 331(p).
Good Manufacturing Practices - Devices must be manufactured in accordance with Good Manufacturing Practices ("GMPs"). FDCA § 520(f), 21 U.S.C. § 360j(f). The device GMP regulations are broadly drawn, and cover such things as equipment, production and process controls, and recordkeeping. See 21 C.F.R. part 820. A device that was manufactured, packed, stored, etc. in conditions that do not meet applicable GMP requirements is adulterated. FDCA § 501(h), 21 U.S.C. § 351(h). Filth, or insanitary manufacturing conditions which could render the device injurious to health, are also potential, but less common, grounds for device adulteration. See FDCA § 501(a), 21 U.S.C. § 351(a).
Labeling - A device is misbranded if its labeling is false or misleading in any particular. FDCA § 502(a), 21 U.S.C. § 352(a). There are also certain formal requirements applicable to device labeling (e.g., the label must bear the name and place of business of the manufacturer, packer, or distributor), and a failure to comply with any of those requirements renders the device misbranded. See FDCA §§ 502(b), 502(c), 502(e)(2), 21 U.S.C. §§ 352(b), 352(c), 352(e)(2); see also 21 C.F.R. §§ 801.1-801.6. In addition, a device is misbranded if it is dangerous to health when used as directed in its labeling. FDCA § 502(j), 21 U.S.C. § 352(j). Finally, over the counter devices (i.e., non-prescription devices) are misbranded if their labeling does not bear adequate directions for use. FDCA § 502(f), 21 U.S.C. § 352(f); see also 21 C.F.R. § 801.109.
Advertising - Jurisdiction over medical device advertising is split between FDA and the FTC. See FDCA § 502(r), 21 U.S.C. § 352(r). When FDA does have jurisdiction, there are certain formal requirements that apply (e.g., the advertisements must contain a brief statement of the intended uses of the device and relevant warnings, precautions, side effects, and contraindications), and the device is misbranded if its advertising does not comply with any of the formalities or if the advertising is false or misleading in any particular. FDCA §§ 502(q)(1), 502(r), 21 U.S.C. §§ 352(q)(1), 352(r). Even when FDA does not have jurisdiction over a device's advertising, however, the agency can use that advertising as a means of showing the intended use of the device (to demonstrate, for example, that the manufacturer intends the device for an unapproved use). See 21 C.F.R. § 801.4.
Medical Device Reporting ("MDRs") - A device manufacturer or importer is required, within specified time periods, to submit reports to FDA whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices: (1) may have caused or contributed to a death or serious injury; or (2) has malfunctioned, and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. FDCA § 519(a), 21 U.S.C. § 360i(a); see also 21 C.F.R. part 803.
Distributor Reporting - Device distributors (including, for some purposes, importers) are required to report similar types of incidents involving devices distributed by them to FDA and/or the manufacturer of the device. FDCA § 519(a), 21 U.S.C. § 360i(a); see also 21 C.F.R. part 804.
User Reporting - Device user facilities are under a statutory obligation to report deaths, serious injuries, and serious illnesses associated with medical devices to FDA and/or the device manufacturer. FDCA § 519(b), 21 U.S.C. § 360i(b).
Failures to Report - The failure or refusal to comply with any of the above reporting requirements is a prohibited act, and renders the device misbranded. FDCA §§ 301(q)(1), 502(t), 21 U.S.C. §§ 331(q)(1), 352(t); see also FDCA § 301(e), 21 U.S.C. § 331(e).
New Rules - Effective July 31, 1996, medical device user facilities and manufacturers are required to report adverse events related to medical devices under a uniform reporting system. The new rules, which will be codified at 21 C.F.R. part 803, replace the manufacturer reporting requirements discussed above and implement the user facility reporting obligation. Under the new rules, device user facilities and manufacturers must, among other things, report deaths and serious injuries which a device has or may have caused or contributed to, and establish and maintain adverse event files. See 61 Fed. Reg. 16043 (Apr. 11, 1996); 60 Fed. Reg. 63578 (Dec. 11, 1995).
Classification of Devices:
Whether a device is required to have a 510(k), or a PMA, or neither, and how all of the other above requirements apply to any particular device, depend on that device's "Class." The FDCA requires FDA to divide medical devices into three classes based on the potential risks and benefits of each kind of device. FDCA § 513(b)(1), 21 U.S.C. § 360c(b)(1); see also 21 C.F.R. part 860.
Class I Devices - Class I devices are those devices, such as doctors' rubber gloves for patient exams, which FDA deems to be in need of the least regulatory oversight. See FDCA § 513(a)(1)(A), 21 U.S.C. § 360c(a)(1)(A); 21 C.F.R. § 880.6250. Class I devices are usually subject to the FDCA's "general controls" for devices, including 510(k), registration, listing, reporting requirements, GMPs, and the prohibitions against adulteration and misbranding. FDCA § 513(a)(1)(A), 21 U.S.C. § 360c(a)(1)(A).
However, FDA can, and does, exempt Class I devices from certain of the general controls, including registration, listing, GMPs, recordkeeping and reporting requirements, and 510(k). FDCA § 513(d)(2)(A), 21 U.S.C. § 360c(d)(2)(A). For example, the agency recently issued a final rule exempting 122 generic types of Class I devices (including dental floss and therapeutic massagers) from 510(k). See 61 Fed. Reg. 1117 (Jan. 16, 1996).
Class II Devices - For Class II devices, the general controls applicable to Class I devices are insufficient to provide a reasonable assurance of safety and effectiveness. Therefore, in addition to general controls, FDA can establish "special controls," such as performance standards and postmarket surveillance, for Class II devices. FDCA § 513(a)(1)(B), 21 U.S.C. § 360c(a)(1)(B); see also FDCA § 514, 21 U.S.C. § 360d (establishment of, and allowable provisions for, performance standards); FDCA § 501(e), 21 U.S.C. § 351(e) (failure to comply with an applicable performance standard renders a device adulterated); FDCA § 502(s), 21 U.S.C. § 352(s) (a device that does not bear the labeling required by a performance standard is misbranded). An example of a Class II device is a CAT scan system. See 21 C.F.R. § 892.1750.
Class III Devices - Class III devices are subjected to the highest level of regulation. Class III devices are those: (1) for which general controls and special controls would not provide a reasonable assurance of safety and effectiveness; and (2) which are either for a use in supporting or sustaining human life, or for a use which is of substantial importance in preventing impairment of human health, or which present a potential unreasonable risk of illness or injury. FDCA § 513(a)(1)(C), 21 U.S.C. § 360c(a)(1)(C). In addition to being subject to general controls, Class III devices must have a PMA. Id. An example of a Class III device is an intraocular lens (a lens implanted to replace the natural lens of the eye). See 21 C.F.R. § 886.3600.
Unfortunately, knowing the class of a device and the applicable requirements is not always a simple matter. In general terms, the rules are as follows:
Classification of "Old" Devices - Most preamendments devices (defined here as devices that were on the market before May 28, 1976) have been classified by FDA. See 21 C.F.R. parts 862-892. If a manufacturer had a device on the market before May 28, 1976, that device is grandfathered and that manufacturer does not need FDA clearance or approval for its device, unless FDA has classified that device as Class III or some aspect of the device, such as in its intended use, has been changed. See FDCA § 510(k), 21 U.S.C. § 360(k). If FDA has classified a preamendments device into Class III, and the agency has issued a regulation calling for the submission of PMAs for that device, every manufacturer of that device will be required to submit a PMA not less than 30 months after the promulgation of a final classification regulation or 90 days after the promulgation of a final regulation calling for the submission of PMAs, whichever is later. FDCA §§ 515(b), 501(f)(1)(A), 501(f)(2)(A), 21 U.S.C. §§ 360e(b), 351(f)(1)(A), 351(f)(2)(A). An important exception, however, is that preamendments devices that were regulated as drugs before May 28, 1976 - devices known as "transitional devices" - are, by statute, automatically Class III and automatically require a PMA, unless FDA reclassifies them. FDCA §§ 520(l), 501(f)(1)(C), 21 U.S.C. §§ 360j(l), 351(f)(1)(C).
Classification of "New" Devices - A new device (i.e., one first introduced or delivered for introduction into interstate commerce on or after May 28, 1976) that may qualify as substantially equivalent to a Class I device that is not exempt from 510(k), to a Class II device, or to a Class III device for which FDA has not called for PMAs, may escape the requirement of a PMA with a cleared 510(k), and once cleared is considered to be the same class as its predicate. See FDCA § 510(k), 21 U.S.C. § 360(k). A new device that is substantially equivalent to a Class I 510(k)-exempt device, is Class I and exempt from 510(k). See FDCA § 513(d)(2)(A), 21 U.S.C. § 360c(d)(2)(A). A new device that is not exempt from 510(k) and does not have a cleared 510(k) is Class III and must have an approved PMA. FDCA §§ 513(f)(1), 501(f)(1)(B), 21 U.S.C. §§ 360c(f)(1), 351(f)(1)(B).
Clinical Investigations of Medical Devices:
A clinical investigation of a medical device will generally be conducted under an Investigational Device Exemption (IDE). An IDE, like its counterpart for drugs, the IND, functions as an exemption from other provisions of the FDCA. See FDCA §§ 520(g), 505(i), 21 U.S.C. §§ 360j(g), 355(i). If a device clinical investigation is being conducted in accordance with the IDE regulations, that device is exempted from, among other things, misbranding, registration, listing, 510(k), performance standards, PMA, certain recordkeeping and reporting requirements, and GMPs. FDCA § 520(g), 21 U.S.C. § 360j(g); see also 21 C.F.R. part 812.
Among other things, the IDE regulations dictate various responsibilities for IDE sponsors and investigators, contain recordkeeping and reporting requirements, and prohibit promotion and sale of the investigational device. See 21 C.F.R. part 812. The failure or refusal to comply with any IDE requirement, or to furnish any information required by the IDE regulations, is a prohibited act. FDCA § 301(q)(1), 21 U.S.C. § 331(q)(1). In addition, if a device is under an IDE, and the IDE sponsor or investigator fails to comply with a requirement of the IDE regulations, the device is adulterated. FDCA § 501(i), 21 U.S.C. § 351(i).
Imports and Exports of Medical Devices:
Imports - The rules for device imports are essentially the same as the rules for drug imports. FDA can refuse admission of a device if the device appears, among other things: (1) to be adulterated or misbranded; or (2) to be forbidden or restricted in sale in the country in which it was produced or from which it was exported. FDCA § 801(a), 21 U.S.C. § 381(a). In some cases, FDA may first give the owner or consignee of the device a chance to re-condition the device, in order to bring it into compliance with the FDCA. FDCA § 801(b), 21 U.S.C. § 381(b).
Exemption for Imports of Certain Components - Effective April 26, 1996, a company can import a component part or accessory of a device, which is ready or suitable for use for health-related purposes, if: (1) the importer submits a statement to FDA at the time of initial importation, reporting that the imported article is intended to be incorporated into a device that will be lawfully exported; (2) the initial owner or consignee of the article keeps records and, if requested makes a report to FDA, regarding the use or disposition of the imported article; and (3) the owner or consignee destroys or exports any component part or accessory that is not incorporated. FDCA § 381(d)(3), 21 U.S.C. § 381(d)(3). The making of a knowingly false statement in any of these required records or reports, the failure to maintain or submit any of the required records or reports, the release into interstate commerce of any of these imported articles or any finished product made from those articles, and the failure to destroy or export any component part or accessory that is not incorporated, are prohibited acts. FDCA § 301(w), 21 U.S.C. § 331(w).
Exports before April 26, 1996 - Devices that complied with all applicable requirements of the FDCA could be exported freely. See FDCA § 801(e), 21 U.S.C. § 381(e). FDA approval was necessary for export of investigational devices, devices that lacked a necessary PMA or did not comply with an applicable performance standard, and banned devices. FDCA § 801(e)(2), 21 U.S.C. § 381(e)(2). Any other device that was adulterated or misbranded could be exported without FDA's permission if it: (1) accorded to the specifications of the foreign purchaser; (2) was not in conflict with the laws of the country to which it was intended for export; (3) was in a shipping package labeled for export; and (4) was not sold or offered for sale in domestic commerce. FDCA § 801(e)(1), 21 U.S.C. § 381(e)(1). Because fulfilling the export requirements exempted the device from adulteration and misbranding, a failure to fulfill any of the requirements rendered the device adulterated and/or misbranded. See FDCA § 801(e), 21 U.S.C. § 381(e).
Exports on or after April 26, 1996 - Devices that comply with all applicable requirements of the FDCA can be exported freely. See FDCA § 801(e), 21 U.S.C. § 381(e).
An investigational device, a device that lacks a necessary PMA or does not comply with an applicable performance standard, and a banned device can be exported with FDA approval, or it can be exported without FDA approval if, among other conditions, it: (1) has marketing authorization in one of certain specified countries; (2) complies with the laws of the country to which it is being exported; (3) accords to the specifications of the foreign purchaser; (4) is in a shipping package labeled for export; (5) is not sold or offered for sale in domestic commerce; and (6) complies with certain manufacturing, labeling, and promotional requirements. FDCA §§ 801(e)(2), 802(a)-(b), 802(f), 21 U.S.C. §§ 381(e)(2), 382(a)-(b), 382(f). The exporter of a device under this latter procedure is required to notify FDA when the exporter first begins to export the device. FDCA § 802(g), 21 U.S.C. § 382(g).
A device that is intended for further processing in anticipation of market authorization in one of the specified countries or for investigational use in one of those countries may be exported in accordance with the laws of that country if, among other things, the device satisfies conditions 3-6 in the previous paragraph. FDCA §§ 802(c)-(d), 802(f), 21 U.S.C. §§ 382(c)-(d), 382(f).
A device that cannot otherwise be lawfully exported and is intended to be used for a disease that is not of significant prevalence in the U.S. can be exported with FDA approval, subject to certain conditions, including conditions 2-6 above. FDCA §§ 802(e)-(f), 21 U.S.C. §§ 382(e)-(f).
Any other device that is adulterated or misbranded can be exported without FDA's permission if it: (1) accords to the specifications of the foreign purchaser; (2) is not in conflict with the laws of the country to which it is intended for export; (3) is in a shipping package labeled for export; and (4) is not sold or offered for sale in domestic commerce. FDCA § 801(e)(1), 21 U.S.C. § 381(e)(1).
Because fulfilling the export requirements exempts the device from adulteration and misbranding, a failure to fulfill any of the requirements renders the device adulterated and/or misbranded. See FDCA § 801(e), 21 U.S.C. § 381(e).
Certain recordkeeping requirements also apply to device exporters. FDCA § 802(g), 21 U.S.C. § 382(g).
Most of the device-related enforcement provisions, and the prohibited acts applicable to devices, are the same as those for food, drugs, and cosmetics. See, e.g., FDCA §§ 301(a)-(c), 21 U.S.C. §§ 331 (a)-(c). There are, however, a few distinct aspects of device-related enforcement:
False Reports - It is a prohibited act to submit any device-related report required under the FDCA that is false or misleading in any material respect. FDCA § 301(q)(2), 21 U.S.C. § 331(q)(2).
Presumption of Interstate Commerce - For medical devices, interstate commerce is presumed. FDCA § 709, 21 U.S.C. § 379a ("In any action to enforce the requirements of this Act respecting a device the connection with interstate commerce required for jurisdiction in such action shall be presumed to exist.").
Seizure - An adulterated or misbranded device, like a counterfeit drug, can be seized at any time, without regard to whether the device is, or has been, in interstate commerce. FDCA § 304(a)(2), 21 U.S.C. § 334(a)(2).
Detention - If, during an inspection, FDA finds devices that it has "reason to believe" are adulterated or misbranded, the agency can order those devices temporarily detained. FDCA § 304(g), 21 U.S.C. § 334(g). The movement of a device in violation of that detention order, or the removal or alteration of a mark required by the order to identify the device as detained, is a prohibited act. FDCA § 301(r), 21 U.S.C. § 331(r).
Civil Penalties - FDA has the authority to impose civil penalties for violations of many device-related provisions of the FDCA. FDCA § 303(f), 21 U.S.C. § 333(f). FDA can impose penalties up to $15,000 for each violation, totaling up to $1,000,000 in each proceeding. Unpaid civil penalties can be collected by the Justice Department in an action in any appropriate federal district court. Id.
[cited in Civil Resource Manual 109]