Page 204 - Biomedical Engineering and Design Handbook Volume 2, Applications

STERILE MEDICAL DEVICE PACKAGE DEVELOPMENT 183

that specifies the requirements for components, device master record, and environmental controls,
just to name a few.
It is appropriate here to present a brief history of how the medical device industry became regu-
lated and how eventually the Food and Drug Administration (FDA) recognized the importance of the
package system as an integral part, and in fact a component of the medical device.
As mentioned earlier, the FDA began regulating medical devices in 1938. At that time, the
Federal Food, Drug, and Cosmetic Act extended the FDA’s legal authority to control foods and drugs
and bestowed the agency with new legal powers over cosmetics and medical devices. However, the
act was limited in scope in that the regulatory actions could only be taken after a device was intro-
duced into interstate commerce, and only after the device was found to be adulterated or misbranded.
Surprisingly, the burden was on the government to provide evidence of violation of the act. In addi-
tion, the 1938 act could not prevent the introduction and marketing of “quack” medical devices.
However, there was also an explosion of legitimate and sophisticated new devices using postwar
biotechnology. These devices not only presented huge potential benefits to patient healthcare, but
also caused an increased risk for harm. It became apparent that additional legal controls were nec-
essary in order to harness the potential good from the new technologies. A government committee
studied the best approach to new comprehensive device legislation, and, as a result, in 1976 a new
law amended the 1938 act and provided the FDA with significant additional authority concerning the
regulation of medical devices. The amendments included classification of all devices with graded
regulatory requirements, medical device manufacturer registration, device listing, premarket
approval (PMA), investigational device exemption (IDE), good manufacturing practices (GMP),
records and reporting requirements, preemption of state and local regulations, and performance stan-
dards. Two years later in 1978, the FDA published the GMP regulations that provided a series of
requirements that prescribed the facilities, methods, and controls to be used in the manufacture,
packaging, and storage of medical devices. The law has since been modified with the most substan-
tive action occurring in 1990 with the passage of the Safe Medical Devices Act (SMDA). It broadly
expanded FDA’s enforcement powers by authorizing the levying of civil penalties and creating a
series of postapproval controls for monitoring the performance of medical devices.
Over the past 18 years, the FDA has significantly changed the way medical devices are regulated.
The issuance of guidance documents effectively circumvented rulemaking and public comment.
Publishing FDA’s interpretation of the GMP effectively causes the manufacturer to comply with that
interpretation. Legally, guidances are not binding on the public, whereas certain rules are. But for all
practical purposes, there is little difference between the two. For example, two of these guidance
documents include
• Guideline on General Principles of Process Validation—1987
• Preproduction Quality Assurance Planning: Recommendations for Medical Device Manufacturers
FDA issues dozens of guidances each year on specific products and processes. The last significant
piece of legislation for medical devices came with the signing of the Food and Drug
Administration Modernization Act of 1997 (FDAMA). This legislation essentially changed FDA’s
approach to standards-based enforcement and adds a system to recognize national and interna-
tional standards in product reviews. The FDA will publish the recognized standards in the
Federal Register, and these standards will then serve as guidance, enabling companies to use
them to satisfy premarket submission requirements through a declaration of conformity. The list
of recognized standards is provided in the FDA Guidance document entitled “Guidance for
Recognition and Use of Consensus Standards: Availability.” This legislative change enables com-
panies to submit a one-page 510(k) that simply states that the device complies with a stated list of
recognized standards.
Significant legislation affecting medical devices and packaging includes
• 1938—Federal Food, Drug, and Cosmetic Act
• 1976—Medical Device Amendments (MDA)
• 1978—GMP Regulations published in Federal Register