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California has a comprehensive medical device protection program that
both complements and supplements the federal medical device program. In some areas,
however, California law differs from federal law. For example, licensing differs
from the federal registration and listing requirements in that it requires manufacturers
to demonstrate a suitable level of compliance with the GMP/QSR regulation as well as other
applicable requirements before they can manufacture and distribute their products in
California. California law requires a licensing inspection. In addition,
California Food and Drug investigators have broad inspection authority and may remove
violative devices from the marketplace on their own authority. Despite these few
differences, manufacturers in California who are in compliance with federal law and who
understand their obligations under state law will have little difficulty in satisfying the
California Requirements. CDPH has a proactive medical device regulatory program that
seeks to provide value for both consumers and industry. Its primary mission is
public health protection, but it also seeks to provide valuable services to the device
industry and to create an efficient and effective regulatory environment in California.
While the focus of medical device regulation in California has changed
somewhat with the evolution of the federal program, the state works in partnership with
the FDA to coordinate its activities, avoid duplication, and work toward a
"seamless" regulatory environment in California.
Legislative History
California has a long history of providing consumer protection in the
medical device area. In 1939, regulation of medical devices was included in the
California Pure Drug Act. The act covered adulteration and misbranding and gave state
investigators the authority to seize medical devices. In 1963 the law was amended to
require the preclearance or premarket approval of both drugs and medical devices.
Under these statutes, it is unlawful to sell, deliver, or give away drugs or medical
devices that are not generally recognized among experts as being safe and effective for
their intended use unless it is done under certain controlled conditions. In 1970
the state adopted the Sherman
Food, Drug, and Cosmetic Law (Division 21 of the California Health and Safety Code), a
comprehensive regulatory program that requires the California Department of Health
Services (CDPH) to inspect and license drug and medical device manufactures in California.
There have been laws specifically regulating medical devices in
California for over 50 years. That California has an active program at all may come
as a surprise to persons familiar with those provisions of the federal Medical Device
Amendments of 1976 that preempt certain state and local device requirements. At the
time the 1976 law was passed, however, there were strong indications that Congress
believed the California program should continue in effect. California filed a
petition for exemption under section 521 (b) of the federal act. The federal Food
and Drug Administration (FDA ) responded to the petition
leaving the California program essentially intact.
Manufacturer Licensing
New Device Manufacturing License Application
(pdf)
Biennial Medical Device Manufacturing License Renewal Application
Manufacturer licensing is a major aspect of medical device regulation in
California. CDPH currently licenses over 900 California medical device
manufacturers. The definition of "manufacture" includes the preparation,
compounding, propagation, processing, or fabrication of any device, including repackaging
and relabeling. Medical device manufacturers within the state must be licensed, and
a separate license must be obtained for each place of manufacture. All manufacturers
are subject to licensing unless specifically exempted. Exemptions currently exist
for pharmacies that manufacture in the course of their regular business of dispensing at
retail, licensed practitioners who manufacture in the course of their professional
practice, persons who manufacture for noncommercial use in nonclinical research or in
teaching, state-registered dispensing opticians who manufacture in the course of the
business of dispensing or selling frames or lenses at retail, and dental laboratories.
Prior to either issuing or denying a license, FDB inspects the
manufacturing facility. Inspections audit compliance with the applicable provisions
of the Sherman Law and
the federal Good Manufacturing Practice (GMP) Quality System Regulation (QSR) regulation,
adopted as a California regulation. California will adopt the federal Quality
System Regulation as well. Once licensed, manufacturers must renew their license
biennially. FDB conducts periodic renewal inspections.
FDB reviews the labeling for each manufactured product as part of the
licensing process. The purpose of the review is to verify that the device, as
labeled, does not require preclearance or premarket approval, that the labeling contains
adequate directions for use or a prescription legend if required, and that there are no
false or misleading statements contained in the labeling. California has not
formally adopted the medical device labeling requirements contained in the Code of Federal
Regulations, but licensees are urged to comply with these requirements in addition to the
general ones contained in California law.
A final aspect of the license review process is verification that the
manufacturer is registered under the registration and listing provisions of the federal
act, and that the manufacturer has filed all premarket notification material required
under Section 510(k) of the federal act. Failure to register is a violation under
California statute. State law does not require compliance with the federal premarket
notification process, but FDB encourages manufactures to file all necessary premarket
notifications.
The California medical device manufacturer licensing program is more
than a registration and listing process since, prior to receiving a license, manufacturers
must demonstrate compliance with all applicable state laws, including the GMP
regulation. It is unlawful to manufacture in California without a license from the
department unless the manufacturer is specifically exempted from the licensing
provisions. In contrast, under the federal act manufacturers must register and
comply with appropriate premarket approval or notification requirements, but they do not
necessarily have to undergo a federal GMP audit or a comprehensive label review prior to
the manufacture and sale of a product. In addition to issuing a license, the department
has the authority to initiate license suspension or revocation proceedings against a
licensee. Any violation of the Sherman Law or the regulations adopted pursuant to it
is grounds for suspension or revocation of a license.
Inspections
Most manufacturers tend to deal with state and federal investigators in
a similar manner during inspections. However, there are differences between federal
and state regulations with regard to inspection authority, disclosure of information,
procedures, and enforcement authority. These differences may be of importance in
planning for state inspections.
An area of concern to most manufacturers is access to records.
California investigators have access under section 110140 of the Sherman Law to any record, file, paper, process,
control, and facility which has a bearing on whether the device is adulterated or
misbranded, or falsely advertised, or whether it has been or is being manufactured,
packed, transported, sold, or offered for sale in violation of that law. In
contrast, section 704 of the federal act makes a distinction with respect to restricted
devices and federal inspection authority. Also, the federal GMP regulation allows
both state and federal investigators access to certain records required by that
regulation.
The California Public Records Act is similar to the federal Freedom of
Information Act in that it requires the disclosure of certain information upon
request. Under the California law, trade secret information is exempt from
disclosure. Manufacturers concerned about the possible release of trade secret
information should clearly mark such material as an aid to CDPH in making this
determination. A description of all the provisions of the Public Records Act is
beyond the scope of this discussion. Manufacturers interested in more information
about by the act are advised to obtain a copy of the California Government Code, section 6250
and following.
Unlike their federal counterparts, state investigators are not required
to present a written notice of inspection prior to inspecting a facility, nor must they
leave a report of inspection findings prior to leaving the premises. California
investigators will leave a report of observations with management after the inspection if
violations are noted, but it is not required that they do so before leaving the
facility. Some investigators prefer to review their inspection findings in detail
prior to leaving anything in writing with management, particularly if several violations
were observed during the inspection. This interim period also gives the
investigators an opportunity to consult reference materials, supervisors, and technical
staff. The investigator will present the completed report of observations to a
responsible individual within the firm and discuss each point.
FDB investigators have peace officer status in California. This
allows them to make arrests, serve warrants, and perform other functions reserved for
peace officers. In addition to the state Health and Safety Code, their enforcement
authority extends to the Penal Code, the Business and Professions Code, and the Food and
Agriculture Code. This authority should not present any particular problems in
planning for state inspections.
Sampling and Embargo
On occasion, FDB investigators are required to sample or embargo
goods. There are differences between state and federal authority with regard to
these practices. Unlike federal investigators, FDB investigators may, under section
111860 of the Sherman Law, embargo devices if there
is probable cause to believe they are adulterated, misbranded, or falsely advertised
within the meaning of the law or if the sale of the device would be in violation of the
law. Any device introduced into commerce in California that is defective, improperly
labeled, unsafe, or otherwise in violation of the Health & Safety Code is subject to
state regulatory activity regardless of whether it is manufactured in California or
not. Embargoed goods may not be removed from the premises, sold, or disposed of
without the permission of an authorized agent of CDPH or the court. Embargo authority
is a powerful regulatory tool that allows immediate removal of violative devices from the
marketplace. State investigators use this authority when necessary to protect the
public health. Should an authorized agent of the department find, or have reasonable
cause to believe, that an embargo will be violated, the state may remove the embargoed
material to a place of safekeeping. Once an embargo has been placed, the department
will seek a suitable disposition of the embargoed material either voluntarily or through
the courts. Disposition may include correction of the violative conditions or
destruction of the embargoed material under the supervision of an authorized agent of the
department.
California law allows any authorized agent of the department to secure
any samples or specimens of any medical device. The agent is required to leave a
receipt for the samples obtained, but there is no provision within the law to allow
payment for them. Efforts are made to avoid undue burden on the manufacturer when samples
are taken, but public health considerations ultimately take precedence over any potential
economic effect on manufacturers in making a decision on whether to obtain samples.
New Devices
The Sherman Law defines a "new device" as any device the
composition, construction, or properties of which are such that such device is not
generally recognized, among experts qualified by scientific training and experience to
evaluate the safely and efficacy of devices as having been adequately shown, through
scientific investigations, to be safe and effective for use. This definition is
similar to that of a Class III medical device under section 513 of the federal act.
Under section 111550 of the Sherman Law no one may
sell, deliver, or give away a new device unless it has received premarket approval under
section 515 of the federal act, or unless CDPH has approved a new device
application. All new-device applications require submission of safety and
efficacy data; a complete list of component materials; a full statement of the
composition, properties, and construction of the device, as well as the principles of its
operation; samples, if requested; and specimens of the proposed labeling and
advertising. Section 111550 does not apply to devices being investigated under the
federal Investigational Device Exemption (IDE) regulations, nor does it apply to devices
with an approved state IDE. California has adopted the federal IDE regulations so the
state and federal IDE requirements are essentially identical.
There are no provisions within the federal act for accepting
state-approved new device applications or investigational device exemptions.
Although one can satisfy California new device requirements by being in compliance with
federal law, the reverse is not true. It is therefore in the best interests of
manufacturers to deal directly with FDA in the clinical investigation and marketing of
their Class III devices.
Performance Standards
The State of California adopts all Federal medical device
standards established pursuant to the Code of Federal Regulations ( 21 CFR
section 514) within 30 days of the Federal adoption.
California has adopted one additional national standard
that was directed by the legislature. This is the 1972 ANSI (American National Standards Institute) Z80 standard for ophthalmic
lenses. FDB constantly monitors the California device industry through its
licensing and inspection programs. If these activities discover a
compelling public health need that is not being addressed at the federal level or
in the event of new legislative requirements new standards are then
recommended or adopted.
Federal Partnership
FDB works in partnership with FDA to
make the best use of limited resources and to avoid duplication of activities.
A memorandum of understanding ( MOU ) that defines the specific
partnership areas is renewed on an annual basis. Partnership initiatives include consolidation of laboratory resources
and field offices, development of standardized inspection procedures and techniques, joint
training, improvement of communication using electronic data sharing and
messaging, work planning and mutual recognition of inspections. This partnership
provides consumers with improved public health protection through
more effectively using the agencies’
combined resources. Additionally the medical device industry
experiences more uniform and consistent
approaches to their regulation in California.
Industry Services
FDB also provides industry services that are consistent with its public
health protection mission, and provide additional value for consumers and industry.
FDB issues export documents to licensed manufacturers who request them to help them export
their products to other countries. This service is provided on a fee-for-service
basis under FDB’s Export
Document Program.
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