FOOD AND DRUG BRANCH

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 (DHS) 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

Medical Device License Application Form

Manufacturer licensing is a major aspect of medical device regulation in California.  DHS 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 annually.  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 DHS 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 DHS 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 DHS 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

Most manufacturers are probably aware of the performance standards provisions contained in the Medical Device Amendments of 1976 and the Safe Medical Devices Act (SMDA) of 1990.   Hundreds of devices have been classified by federal regulation into the Class II performance standards category.  California does not have an equivalent device classification process, but California law allows DHS to establish standards for devices to provide reasonable assurance of safe and effective performance.  This section also adopts as California standards all standards established pursuant to section 514 of the federal act.

California has not established any standards for medical devices, except for the 1972 ANSI (American National Standards Institute) Z80 standard for ophthalmic lenses, which was adopted by legislation and is currently under review.   It is unlikely that California will develop any additional performance standards unless a compelling public health need materializes in California that is not being satisfactorily addressed at the federal level or unless required by legislation.

Federal Partnership

FDB works in partnership with FDA to make the best use of limited resources and to avoid duplication of activities.   Both agencies have committed themselves through a memorandum of understanding, specific partnership agreements, and contracting, to work toward a seamless regulatory environment in California.  Partnership initiatives include consolidation of laboratory resources and field offices, development of standardized inspection procedures and techniques, joint training, improvement of communication through upgrading of electronic data sharing and messaging, work planning and mutual recognition of inspections.  This partnership means that consumers will get the best public health protection that the agencies’ combined resources can provide, and the industry will see a uniform and consistent approach to regulation in California.  In addition, DHS currently inspects approximately 100 device manufacturers per year under federal contract.   These inspections also serve as state licensing inspections.

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.

FDB is recognized by FDA as a reviewer in the federal Third-Party Review Pilot Program.  This voluntary program allows qualified third-parties to review selected federal premarket notification (510(k)) applications on a fee-for-service basis. The pilot program is in response to industry requests for speedier 510(k) clearances.  It gives companies the option of paying a third-party to review their 510(k) submissions rather submitting them for federal review.   FDB will review applications from California manufacturers only.