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FDA's Telemedicine Related Activies Report, dated July 11, 1996, is attached below. Additional telemedicine information can be found at the following Internet sites:
Office for the Advancement of Telehealth, Health Resources and Services Administration http://telehealth.hrsa.gov/pubs.htm
FDA's Regulatory Role as reported in "2001 Report to Congress on Telemedicine, Safety and Standards"
http://telehealth.hrsa.gov/pubs/report2001/safety.htm#fda
The appended report describes telemedicine-related activities of the Center for Devices and Radiological Health, FDA. It also details a variety of Center initiatives being undertaken to clarify and improve Center operations in this area. The Center is eager to receive comments and questions concerning the issues raised in this document. These should be addressed to
Everette T. Beers, Ph.D. (HFZ-460) etb@cdrh.fda.gov
FAX: 301-480-4201
The Center for Devices and Radiological Health, FDA in response to a DHHS Telemedicine Working Group request has produced the appended brief report describing its activities related to telemedicine. The Center is responsible for ensuring the safety and effectiveness of the medical devices used in telemedicine systems, and all of the main programmatic areas of the Center include telemedicine related activities:
Premarket review of telemedicine devices: The Center carries out premarket reviews of medical devices used in telemedicine systems. The most striking example of this is the evaluation of picture archiving and communications systems (PACS) which undergo routine review and for which a proposed device classification action, exempting many devices from significant review requirements, has been proposed. The Center stresses its commitment to the open, public development of guidance documents and Center policy addressing telemedicine devices. A particularly high priority is being placed on the development of Center policy with regard to software medical devices.
Postmarket surveillance: The Center maintains a program of postmarket surveillance of medical devices and is striving to better adapt this program to the receipt and management of telemedicine device adverse event data.
Quality systems: The Center believes that good manufacturing practices, including design controls, represent one of the best approaches toward the assurance of telemedicine device safety and effectiveness.
Standards development: The Center is committed to participation with the medical, manufacturing, and patient communities in the development of standards, including device, practice, and nomenclature standards, which provide the necessary environment for telemedicine systems to flourish.
Telemedicine related scientific research: The Center carries out research related to telemedicine, in particular in the development of performance evaluation methodologies for components of telemedicine systems and for the evaluation of electromagnetic compatibility issues.
The CDRH recognizes the seriousness of its role in the regulation of this technologically complex and rapidly evolving field and is deeply committed to carrying it out in a responsive and responsible manner.
Telemedicine, the "application of telecommunications to the care of individual patients," is becoming increasingly important to the United States health care delivery system. The Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA) bears the responsibility for the regulation of medical devices and radiation-emitting electronic products used for telemedicine, and as such plays an important role in the development of telemedicine in the United States. Each of the Center's principal areas of responsibility -- premarket review, postmarket surveillance, quality systems, standards, and science -- include program activities related to telemedicine, and this report outlines these activities and highlights issues critical to the appropriate treatment of telemedicine devices. Following an introductory section devoted to general issues, these efforts are addressed by type of activity, with primary emphasis on device premarket approval and standards development. A final section identifies critical initiatives pertinent to the Center's regulation of telemedicine devices. The overall plan of the report is as follows:
This report was prepared in response to a request by the Joint Working Group on Telemedicine, constituted as an interagency working group by the Department of Health and Human Services in response to the Vice President's request that the Department take the lead with respect to health care applications of the National Information Infrastructure. The CDRH is represented on the Working Group and has taken part in its deliberations. The Working Group is using preliminary "working definitions" of telehealth and telemedicine, reserving "telehealth" for general health care services and "telemedicine" for individual patient care (see Appendix A).
The Working Group definition of telemedicine is convenient for use here, since the Center's primary medical device concern is for devices used for individual patient care. Of course, in addition to its regulatory authority for medical devices, the Center also has radiological health authorities which apply to all radiation emitting electronic products whether or not used in a medical context. These, for example, provide the statutory authority for limitations on x-ray emissions from video monitors even when used solely for nonmedical purposes and for CDRH research aimed at resolving questions concerning possible health effects of low level electro-magnetic fields emitted by such monitors. The focus of this report is on the use of telemedicine to provide clinical services to individuals and not on community-based or administrative applications. According to the Working Group, clinical telemedicine is:
The delivery and provision of health care and consultative services to individual patients and the transmission of information related to care, over distance, using telecommunications technologies, and, incorporating the following activities:
I. Direct clinical, preventive, diagnostic, and therapeutic services and treatment, including procedures where a provider may be present with the patient, and clinical training and consultative clinical Grand Rounds, if used for decision making regarding the clinical care of a specific patient.
II. Consultative and follow-up services.
III. Remote monitoring, including the remote reading and interpretation of results of patient's procedures.
IV. Rehabilitative services.
V. Patient education provided in context of delivering health care to individuals.
The CDRH is a major participant in the telemedicine community through its regulatory authority over many products used in telemedicine. By the terms of the Federal Food, Drug, and Cosmetic Act, Sec. 201. [321 of US Code title 21] (h) The term "device" ... means 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.
Devices used in telemedicine activities (I) to (IV) are obviously subject to the Center's medical device regulatory authority, and those related to activity (V) are integral to that authority when the "education" is medical device labeling information.
The Medical Device Amendments of 1976 (the Act) (Public Law 94-295) and the Safe Medical Device Amendments of 1990 (SMDA) (Public Law 101-629) established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the Act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval (PMA)). A device that is first offered in commercial distribution after May 28, 1976, and which FDA determines to be substantially equivalent to a device classified under this scheme, is classified into the same class as the device to which it is substantially equivalent. The Center determines whether new devices are substantially equivalent to previously marketed devices by means of premarket notification (510(k)) procedures described in section 510(k) of the Act. A device that was not in commercial distribution prior to May 28, 1976, and that has not been found by FDA to be substantially equivalent to a legally marketed device, is classified automatically by statute (section 513 (f) of the Act) into class III -- requiring submission of a PMA -- without any FDA rulemaking proceedings. Class I devices may be granted various degrees of exemption from the general controls specified by the amendments, e.g., an exemption from GMP review and/or from 510(k) submission for that generic type of device.
All 510(k) and PMA submissions are reviewed by the Center's Office of Device Evaluation in one of the Office's six divisions. Many of the telemedicine device submissions are for medical image management devices and are reviewed within the Division of Reproductive, Abdominal, Ear, Nose, and Throat and Radiological Devices (DRAERD), since most medical imaging devices fall within the purview of that division. Many of these devices are referred to as picture archiving and communications systems (PACS), since they are principally utilized for the communication and storage of images and are often used in teleradiology applications. Since they typically handle the image data in digital form, they also facilitate the application of image processing and enhancement techniques that must be considered during the review process. Review of these devices is carried out considering issues raised in a draft guidance document: Guidance for the Content and Review of 510(k) Notifications for Picture Archiving and Communications Systems (PACS) and Related Devices (8/93). Salient points covered by the guidance document include the following:
- Applicable Radiation Control for Health and Safety Act standards (x rays from video monitors and light from lasers)
- Potentially applicable voluntary standards (e.g., the ACR/NEMA data exchange standard mentioned below)
- Types of information to be included in the submission -- simplified so that where standard, general purpose equipment is utilized [as a component] it is only necessary to provide the manufacturer, trade name, and a brief description.
- Special instructions regarding lossy [irreversible] compression, including a requirement for on-screen labeling
- Detailed instructions regarding software used in the system, including the requirement for a description of the software development process and provision for a separate signed certification by "a responsible company official that the software information provided" is correct.
Premarket notification review of PACS devices by DRAERD (in consultation with the Office of Science and Technology (OST)) has been generally noncontroversial. There is, however, increasing manufacturer interest in including image processing software in such products, in particular, the addition of features with explicit diagnostic claims such as computer-aided diagnosis (CADx), e.g., location of potentially malignant lesions in mammograms. These new features raise issues that probably will require updating the review guidelines.
One problem with PACS review has been the lack of a product classification regulation under which PACS devices could be reviewed. Historically, these devices have been addressed as accessories to the (classified) imaging devices they serviced. The lack of classification regulations has not allowed the Agency to establish exemption from any of the general controls for some of these devices where it would be appropriate. To remedy this situation a classification proposal has been developed and is awaiting Federal Register (FR) publication establishing classifications for five medical image management devices. Under the proposal, medical image storage devices and medical image communications devices would be classified into class I (general controls), and products that do not utilize irreversible compression would be exempted from the requirement of premarket notification. Medical image digitizers, medical image hardcopy devices, and picture archiving and communications systems would be classified into class II (special controls).
It should also be noted that the classifications are not considered to apply to general purpose products, such as general purpose software, digital communications devices, and storage devices that are not intended for medical use. The Center recognizes that such products may be used in a medical setting, and ordinarily they are not considered to be medical devices. However, when such general purpose products are labeled for medical use, or included as components of systems labeled for medical use, they are considered to be within the scope of the proposed classifications. These points are amplified further below.
Software is an important component of a PACS device. It is generally responsible for data file organization, and also may provide image processing functions such as filtering (e.g., edge enhancement), measurement (e.g., distance, area and volume determinations), and special image displays (3D surface and volume rendering). Stand-alone software, incidently used but not marketed for use in PACS devices would not be included in the proposed classification (e.g., spread sheet programs, etc.). As noted earlier, software medical devices are becoming of increasing importance, and the development of Center policy concerning them is described below.
Other ODE divisions are also involved in the review of telemedicine devices. For example, the Division of Cardiovascular, Respiratory, and Neurological Devices (DCRND) is responsible for the review of ECG monitors, including those which involve the capability for remote monitoring. Most of these cardiovascular devices are handled through the 510(k) process, including devices which permit the remote physician analyst to carry out pacemaker reprogramming and even remote initiation of cardiac defibrillation. Devices for remote telemetry of such physiological parameters as body temperature would be reviewed in the Division of Dental, Infection Control and General Hospital Devices (DDIGD). The involvement of other FDA components should also be noted, e.g., the Center for Biologics Evaluation and Research (CBER) has approved a home use HIV test kit with telephone test reporting and counseling.
Although device evaluation and classification assignment (Section 513(g)) are carried out by ODE, the Office of Compliance (OC) is charged with the responsibility for responding to manufacturer inquiries regarding whether or not a particular product is a medical device and thus subject to Center regulatory authority (device determination). Products (e.g., software and computer products) that are not sold with a medical purpose, but that are incidentally used for a medical purpose, are legally general purpose articles and are exempt from all requirements of the Act except for the prohibitions against adulteration and misbranding. Products which are components of or accessories to a medical device are typically regulated in the same way as the "parent" device. That is, for example, if the parent device is subject to GMPs and premarket notification, the normal presumption is for an accessory to be subject to the same requirements, even if marketed separately. Furthermore, the manufacturer of a device is responsible for assuring that the full device, including all components, complies with the regulations. The medical device manufacturer is responsible for the safety and effectiveness of all components, including any general purpose articles incorporated within the device.
With regard to stand-alone software products, products which fit the definition of a medical device but are not a component of or accessory to a medical device, the current CDRH regulatory approach is described in a draft 1989 policy statement "FDA Policy for the Regulation of Computer Products." Computer products "intended only for use as traditional library' functions" or "as general accounting or communication functions" or "solely intended for educational purposes" are acknowledged not to be subject to FDA regulation. Moreover, software may be covered by the above noted "general purpose" exemption (21 CFR 807.65(c)), a "licensed practitioner" exemption described below (21 CFR 807.65(d)), or an exemption for software used in teaching and non-clinical research (21 CFR 807.65(f)). In addition, unclassified information management products and decision support systems are suggested for provisional exemption from registration, listing, premarket notification, MDR, and GMP requirements. This draft policy was proposed to apply to those devices that could be shown to provide for "competent human intervention" before the results of any data manipulation would be applied to patient care and was to apply until such time as a formal policy on these devices were established. The draft policy has not as yet been finalized, but initiatives currently underway to revise it are described below.
Even if a product is a medical device, it may be exempt from certain requirements if the manufacturer falls within one of several categories specified by the Act or implementing regulations. In particular, an individual physician ("licensed practitioner") who develops a medical device genuinely for use in his own personal practice is exempt from the registration and listing and 510(k) provisions of the Act. Other provisions, however, including those against adulteration and misbranding, continue to apply. Note that the Agency has determined that multiple site use of a device (even within the same company) constitutes commercial distribution, as stated in a 22 March 1982 letter to the Rohm and Haas Company (Appendix B). Furthermore, other provisions, including those against adulteration and misbranding, continue to apply.
An important factor in determining whether a product that fits the definition of a medical device has been entered into commercial distribution is whether or not it is a finished product. This issue arose when the question was asked of the Agency as to whether a software product, developed under a research grant could be shared as research results with other similar research groups. In an effort to draw a clear line between legitimate sharing of research results and commercialization of a medical device, CDRH outlined its policy in a 20 October 1995 letter to Professor Edward L. Chaney of the University of North Carolina School of Medicine (Appendix C).
In an effort to clarify which software is subject to regulation, FDA considers as evidence of a distributor's intended use for the software, all factors related to promotion or distribution ... as well as two additional factors. The first factor is whether the distributed software is in executable vs. source code format. Source code is not readily usable on any computer unless it is translated into executable code. Executable code, on the other hand, can be run on computers with no translation or further action on the part of the user. ... Source code itself is not considered to be a finished medical device. ... Dissemination in source code could occur through publication in an appendix to an article or through reprints of such an article, through distribution on computer disks, or through display over the Internet. The second factor that FDA considers in determining whether software is objectively intended to be used as a device is whether the device is being commercially distributed, in exchange for an express or implied payment. ... If the recipient compiles the source code to executable code with the intention to use it for medical purposes, the recipient would be required to seek clearance either by FDA or through the approval by an Institutional Review Board (IRB) for its use [as an investigational device].
This policy is under review, as noted in the critical initiatives section.
Because software is integral to the operation of most telemedicine systems, efforts to update Center policy with respect to software are important elements of the Center's approach to regulation in this field. At the present time four major efforts are underway to define and develop software policy. First, a CDRH task force is developing overall Center software policy. This policy will clarify the factors that determine which software is a medical device and the degree of regulatory scrutiny it must face. The next step in the development of this policy is the convening of a public workshop to be held September 3-4 of this year. The draft FR notice prepared to announce the workshop describes the purpose of the workshop as follows:
...to obtain information on subjects such as: (1) definitions that could be used in the classification of medical software devices; (2) criteria that could be used to define risk categories; (3) the scope and content of a proposed software quality audit that might be used in lieu of conventional premarket notification for certain medical software devices; (4) factors related to the unique characteristics of the distribution of software that the agency could consider in determining whether a particular medical software product is intended by the manufacturer or sponsor for commercial distribution; and (5) potential scenarios and regulatory hurdles to implementing a risk-based classification process. This will provide FDA with information to better assess the risks to public health associated with different types of medical software devices.
Several discussion papers are being prepared on these topics to help focus an interchange on the key issues involved.
The other three software efforts are seeking to further delineate and extend the overall software policy by (1) developing a revision to the current reviewer guidance for premarket submissions for software used in medical devices, (2) developing reviewer guidance for software devices used for computer-aided diagnosis (CADx), and (3) developing a policy on the use of commercial off-the-shelf software (OTSS) in medical device applications. The CADx effort is being carried out by a Computer-Aided Diagnosis Working Group and has progressed to the point of holding a public meeting on 26 January 1996 to solicit public comment on this subject, attended by over 200 participants, and issuing the minutes for that meeting.
The Mammography Quality Standards Act (MQSA) of 1992 gives the Center a special role to play in the regulation of mammography, including the regulation of personnel, equipment, practices, and procedures in use in mammography facilities. The Division of Mammography Quality and Radiation Programs, Office of Health and Industry Programs (OHIP) will be responsible for the interpretation and development of standards where necessary to make them specifically applicable to telemammography as that becomes a viable modality.
Many devices applicable to telemedicine may be derived from technologies developed in the defense, space, or intelligence communities. In order to assist such technology transfer activities the Center has established a Technology Transfer Taskforce (T3). One example of the work of this taskforce is assistance provided to the Advanced Research Projects Agency (ARPA) and its contractors regarding the premarket approval process for telemedicine devices.
In addition, Center staff participate in a PHS Office of Women's Health/intelligence community working group on the transfer of intelligence community technology for medical use. Additional discussions are underway with the U.S. Army Medical Research and Material Command related to the use of new technologies for combat care and more general medical use. Discussions are also continuing with the National Cancer Institute which has included CDRH in activities involving its Diagnostic Imaging Research Branch technology transfer efforts with the National Aeronautics and Space Administration. The CDRH Division of Small Manufacturers Assistance "Swords into Plowshares" initiative is pursuing programs to assist companies and researchers that are interested in technology transfer to the medical device arena, and preliminary discussions have been held with representatives of other federal agencies to develop a coordinated approach to advising industry researchers and others with regard to regulatory, funding, and other issues relevant to the health care community.
The Office of Surveillance and Biometrics (OSB) carries out the postmarket surveillance activities of the Center, including the annual review of over 100,000 device-related adverse event reports as well as oversight for implementation of required and discretionary post market surveillance studies. Although telemedicine per se has not been the focus of required and discretionary postmarket surveillance studies, telemedicine may be employed in their conduct. For instance, certain sponsors conducting discretionary studies of pacemaker lead failures have used transtelephonic monitoring (TTM) as a mechanism for patient follow up.
The existing adverse event database is very difficult to "sort" for telemedicine-related incidents, but it appears that very few have been reported to date. The main barriers to reporting telemedicine-related adverse incidents are that (1) there has not been any specific reporting guidance developed that addresses the reportability of telemedicine-related events, (2) many manufacturers of telemedicine-related systems have considered their products exempt from FDA regulation, and (3) other barriers to voluntary reporting exist, such as concerns regarding litigation and lack of awareness by physicians and others of the FDA voluntary reporting systems. Some problems such as image reversal (left-for-right), labeling of images with incorrect patient data, and incorrect transmission of patient data between various systems have been reported.
The Center is vitally interested in the development of standards (voluntary or otherwise) that improve the Center's ability to characterize and evaluate medical devices. This applies to equipment standards, process standards (such as for developing software), and efforts to standardize nomenclature. Standards are also vital to the success of telemedicine. Few elements of the computer world are as frustrating as the inability to interconnect different devices and communicate successfully among them. Standards are required to allow such successful communication. There is a plethora of standards-setting organizations, and the Center has played a modest but still significant role in many of the standards efforts.
The Center was instrumental in encouraging the collaboration between the manufacturers of diagnostic imaging equipment, represented by the National Electrical Manufacturer Association (NEMA), and the clinical community, represented by the American College of Radiology (ACR), to develop a standard allowing for the interconnection of diagnostic imaging systems. The ACR/NEMA effort has produced a Digital Imaging and Communications in Medicine (DICOM) standard which is widely implemented and serves as the foundation for successful PACS applications. In addition, ACR and NEMA have expanded the effort to include several other professional organizations and to include international collaboration with the assistance of Center staff. Approval of this document as an American National Standard may be pursued in the future by NEMA, which is accredited by the American National Standard Institute (ANSI). Two programs with significant Center involvement are the Compression and Display Function ACR/NEMA working groups.
There are many different standards efforts that impact telemedicine and have had limited Center participation, many with international standards-setting organizations. The complexity that has existed at the national level in healthcare informatics standards, because of the variety and evolving nature of relevant technologies as well as the many players involved, has expanded even more in view of the international interest in such standards. For telemedicine standards to be most useful, standards must be promulgated at the international level. The Center has been participating in an effort to coordinate healthcare informatics standards activities in the United States and to facilitate international cooperation in related standards activities. The Center has worked closely with the Agency for Health Care Policy and Research (AHCPR) in this effort. To some extent, this collaborative effort resulted in response to the formation of Technical Committee 251 (Medical Informatics) by the European Committee for Standardization (CEN) in 1990. In order for CEN/TC 251 to obtain a unified United States response to its proposals and to establish liaison with American standards efforts, in late 1990, the Secretary-General of CEN asked ANSI to play a coordinating role for relevant U.S. standards efforts and suggested contact points in CDRH and AHCPR. As a result an ANSI planning panel was formed, the Healthcare Informatics Standards Planning Panel (HISPP). Its mission was described as follows:
To perform the functions of a Standards Planning Panel per Section C2.3 of the ANSI Procedures for the Development and Coordination of American National Standards in the field of healthcare informatics standards. Specifically, the planning panel would coordinate the work of the standards groups for healthcare data interchange and healthcare informatics (e.g., ACR/NEMA, ASTM, HL7, IEEE) and other relevant standards groups (e.g., X3, X12) toward achieving the evolution of a unified set of non-redundant, non-conflicting standards that are compatible with ISO [International Standards Organization] and non-ISO communications environments. In addition, a balanced subcommittee of the planning panel shall interact with and provide input to CEN/TC 251 (Medical Informatics) in a coordinated fashion and explore avenues of international standards development (e.g., ISO and IEC).
A Center staff member served on HISPP and was co-chair of the HISPP Subcommittee on International and Regional Standards Issues (ISC). HISPP has been upgraded by ANSI from a planning panel to a "standards board" (HISB). The Center has maintained liaison to HISB and its committees.
Since medical devices are increasingly incorporating electronics and microprocessing systems, and at the same time, there is a proliferation of "wireless" communications that can link the devices together and aid in the diagnosis and treatment of patients, electromagnetic interference (EMI) with medical devices, particularly from emissions of the wireless technology, has become a serious concern. Even the direct wired communications with devices and among clinicians can suffer from EMI. Thus, telemedicine must address the issue of EMI, i.e., assure the electromagnetic compatibility (EMC) of the systems involved in the medical environment.
CDRH is leading the efforts in the U.S. to make all medical devices compatible with the electromagnetic environment that they now face and, as much as possible, with what might be faced in the foreseeable future. This effort requires the input and cooperation of all those involved with the device industry: device manufacturers, the electromagnetic energy industry (power, radio and TV, cell phone, computer, electronics), clinicians, users, and the public. CDRH is presently embarking on a course to require evaluation of EMC in all appropriate devices, and to harmonize its efforts with the international community (particularly the European Union (EU), which now has in place an EMC Directive to require all products and devices to address EMC). A strategy has been developed by CDRH to incorporate EMC into all aspects of the medical device regulatory process, including: premarket review and regulation, postmarket regulation, research, national and international standards activities, and information dissemination and cooperation through professional societies and other government agencies.
Nomenclature standardization is also vital for telemedicine to be viable and is of great importance to the efficiency and effectiveness of many of the Center's programs. Two areas are of prime concern: (1) standardized clinical terminology for use in describing patient events and (2) standardized conventions and terminology for the naming of devices. To date, the Center has not had the benefit of a fully developed lexicon to describe patient events and to permit searching the adverse event reports database for these events. Similarly, the nomenclature employed to identify products for the purposes of searching a host of Center databases is in need of review, not only to establish standard internal procedures for the naming and categorization of products but also to harmonize the Center's device nomenclature as part of international harmonization efforts.
Over the past two years, FDA has been actively involved with the review and development of standardized clinical terminology to describe patient events in the form of a thesaurus for regulatory purposes. The thesaurus, known as the Medical Dictionary for Drug Regulatory Affairs (MEDDRA), reflects a sophisticated multiaxial, hierarchical terminology. The CDRH is currently reviewing MEDDRA from a device perspective. This effort traces its origin to the medical terminology created by staff at the United Kingdom (UK) Medicines Control Agency (MCA) for in-house use with their data base, the Adverse Drug Reactions On-line Information Tracking (ADROIT) system, designed to facilitate work in pharmacovigilance. This was the UK equivalent of the FDAs Coding Symbols for a Thesaurus of Adverse Reactions Terms (COSTART) and also corresponded to a World Health Organization Adverse Reaction Terminology (WHO-ART) and to the International Classification of Diseases 9th revision (ICD-9). This evolved in 1993 into the review and development of a new terminology (MEDDRA) which had FDA participation from its inception, with OSB taking the lead for CDRH. By mid-1996, FDA is to decide on adoption of MEDDRA for regulatory purposes, with an initial terminology focus on safety.
With regard to the naming and categorization of devices, CDRH for the past two years has been a participant in European standardization activities addressing the development of a harmonized device nomenclature. Recently, ISO has become involved with the intent of establishing an international standard, an effort in which CDRH will be an active participant. To work towards such a standard, CDRH has recently engaged the ECRI in an exchange of information and evaluation of their respective nomenclature systems. In addition, CDRH has established a product code working group to help in the latter efforts as well as to assess the internal workings of CDRH's system.
Manufacturers establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products are known as Current Good Manufacturing Practices (CGMPs). CGMP requirements for devices (21 CFR part 820) were first authorized by section 520(f) of the Act, which was among the authorities added to the act by the Medical Device Amendments of 1976. The 1990 SMDA amended section 520(f) of the act, providing FDA with the explicit authority to add preproduction design controls to the CGMP regulation. The CGMP regulation is applicable to all medical devices including telemedicine devices, and design controls are of particular relevance to software medical devices, since a study of software-related recalls for the period of Fiscal Year (FY) 1983 through FY 1991, indicated that over 90 percent of all software-related device failures were due to design-related errors, generally, the failure to adequately validate software prior to routine production. In the Center's regulation of telemedicine devices, the quality systems approach will play a key role.
The Office of Science and Technology has carried out a research program of direct relevance to telemedicine. This is particularly true with regard to teleradiology. OST research on the evaluation of the performance of imaging systems has played a crucial role in the improvement of such systems and the ability to optimize transmission of medical images. OST has developed performance evaluation methodologies, including those for the evaluation of image compression, and has supported and participated in studies of the requirements for teleradiology systems. A second area of OST research directly related to telemedicine (telesurgery) is the evaluation of endoscopy display technology.
The CDRH has a crucial role to play in the emergence of viable telemedicine systems. In this section a number of Center initiatives in pursuance of this role are highlighted.
1. Clear delineation of the Center's regulatory posture with respect to telemedicine devices assists the medical and manufacturing communities in the development of telemedicine systems.
2. The degree of specificity of indications-for-use in device approvals plays a role in the ease of implementation of telemedicine systems.
3. The Center needs to assure that the appropriate classification framework is in place for the device approval process to function properly.
4. The regulatory status of software products is of particular concern to the telemedicine community.
5. The Center has applied very little regulatory oversight to a broad class of stand alone software which is becoming central to health care in this country -- the CADx or "health care advisory" decision support systems. Even electronic patient records, heretofore largely record keeping systems, have begun to include decision support and expert system applications which bear directly on individual patient care through provision of treatment options or recommended treatments based on data in the patient's record, perhaps automatically collected through interfaces to a variety of medical devices.
6. Telemammography is not specifically addressed by current MQSA interim or proposed rules.
1. The surveillance program does not receive all appropriate telemedicine related incident reports.
2. Use of modern telecommunications capabilities will enhance the Center's surveillance efforts.
1. Appropriate evaluation methodology for assessment of the performance of many telemedicine devices has not yet been developed.
2. EMC problems will become more severe as communications media, in particularly wireless communications, increasingly come into play.
(Updated August 5, 1997)
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