Medical Devices and Packaging: Not Such Strange Bedfellows
By Keller and Heckman LLP’s Packaging Practice Group
This month, PackagingLaw.com turns its focus to medical devices -- a topic that may seem peculiar, given that medical devices are not, per se, packaging materials.
Nevertheless, packaging materials suppliers will likely find a focus on medical devices to be of general interest, since many of the same materials used in the manufacture of packaging materials are used in the production of medical device components. Indeed, some medical device manufacturers even insist that the component materials used in the production of their devices be specifically cleared for use in food packaging applications by the U.S. Food and Drug Administration (FDA). As discussed below, this position stems from the way in which FDA regulates medical device components.
Section 201(h) of the Federal Food, Drug, and Cosmetic Act ("the Act") defines a "device," in relevant part, as:
an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is--
. . .
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease . . .
. . .
which does not achieve any of its principle intended purposes through chemical action within or on the body . . . and which is not dependent upon being metabolized for the achievement of any of its principle intended purposes.
The Medical Device Regulations issued under the Act require manufacturers of medical devices to:
- register the device establishment with the FDA;
- submit to FDA a list of devices manufactured, propagated, compounded, or processed;
- submit a premarket notification (PMN) or, in the case of Class III devices,1 a Premarket Application (PMA) for the device; and
- maintain records to assure that the device is safe and effective and is not adulterated or misbranded.
Manufacturers of medical devices are also required to follow good manufacturing practice (GMP) requirements, which are found in regulations promulgated by FDA governing the manufacture, packaging, storage, and installation of medical devices. Although the manufacturer of a component or accessory of a device technically is a device manufacturer, in most cases it is the manufacturer of the finished medical device who must comply with these requirements and who is responsible for determining the safety and suitability of the entire product. Nevertheless, manufacturers of components of medical devices frequently are called upon by their customers to assist in providing assurance that their products may be considered safe and suitable for the intended use in medical devices.
In this regard, when a finished device manufacturer submits a PMA or PMN to FDA, the manufacturer often needs to include information on components or materials used in the production of the device. This information may be considered by the component manufacturer to be confidential. Therefore, FDA permits component manufacturers to submit confidential information on their products directly to the agency in the form of a Medical Device Master File (MAF). The MAF is reviewed by FDA only in connection with the agency's review of a PMA or PMN, and is maintained by FDA as confidential; therefore, the information contained in an MAF is not disclosed to the component manufacturer's customers.
The information in an MAF frequently includes formulation information on the supplier's materials, as well as references to any Food Additive Regulations (or Food Contact Notifications) under which the components of the materials are cleared. Although not required for device components, clearances under FDA's Food Additive Regulations do, in some cases, assist device reviewers in determining that a material may be considered safe for use in certain medical device applications.
Consequently, in some instances, manufactures of medical devices insist that suppliers' materials be cleared by FDA for use in food-contact applications. Of course, it should be emphasized that such clearances are not required by FDA for medical device components, and food additive clearances do not, themselves, provide a sufficient basis upon which to conclude that a material is safe and suitable for use in medical devices. Nevertheless, such clearances may provide an additional measure of comfort in evaluating the safety of a material for use in some medical device applications.
1All medical devices are placed into one of three regulatory classes: Class I devices are not intended or represented to be for use in supporting or sustaining human life or for a use that is of substantial importance in preventing impairment of human health. These devices generally are less invasive than other devices, and do not present a potential unreasonable risk of illness or injury. Class I devices are subject only to "general controls," which include registration and listing with FDA, premarket notification, medical device reporting, and good manufacturing practice.
Class II devices are devices for which "general controls" alone are insufficient to provide a reasonable assurance of safety and effectiveness. Devices in this category are subject to "special controls" including performance standards, postmarket surveillance, guidelines, recommendations, and other appropriate actions designed to assure safety and effectiveness.
Finally, Class III devices include life sustaining and life supporting devices, and devices that are intended for implantation in the human body. These devices must receive FDA approval through the more extensive premarket approval (PMA) process before they are put into commercial channels.