The Food and Drug Administration
Digital Health Initiatives
The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. Providers and other stakeholders are using digital health in their efforts to:
Patients and consumers can use digital health to better manage and track their health and wellness related activities. The use of technologies such as smart phones, social networks and internet applications is not only changing the way we communicate, but is also providing innovative ways for us to monitor our health and well-being and giving us greater access to information. Together these advancements are leading to a convergence of people, information, technology and connectivity to improve health care and health outcomes.
Why is the FDA focusing on Digital Health?
Many medical devices now have the ability to connect to and communicate with other devices or systems. Devices that are already FDA approved or cleared are being updated to add digital features. New types of devices that already have these capabilities are being explored.
Many stakeholders are involved in digital health activities, including patients, health care practitioners, researchers, traditional medical device industry firms, and firms new to FDA regulatory requirements, such as mobile application developers.
FDA’s Center for Devices and Radiological Health is excited about these advances and the convergence of medical devices with connectivity and consumer technology. The following are topics in the digital health field on which the FDA has been working to provide clarity using practical approaches that balance benefits and risks:
How is the FDA advancing Digital Health?
CDRH has established the Digital Health Program which seeks to better protect and promote public health and provide continued regulatory clarity by:
Federal Trade Commission (FTC) Mobile Health Apps Interactive Tool
If you are developing a mobile health app that collects, creates, or shares consumer information, click on the button to take you to the tool on Federal Trade Commission’s website to find out when FDA, Federal Trade Commission (FTC) or Office of Civil Rights (OCR) laws apply.
Link: http://www.fda.gov/medicaldevices/digitalhealth/
The use of advanced telecommunications technology to deliver health care brings with it a host of concerns about safety and effectiveness. For instance, does a cardiologist at an urban medical center, using an electronic stethoscope, get the proper sound resolution to effectively make a proper diagnosis during a teleconsult with a patient in a rural clinic? Will a technology that works for one specialty be equally safe for use in another specialty?
Many of the telemedicine systems in use today are adaptations of existing teleconferencing or desk top computer systems which were originally designed for purposes other than health care delivery. Although the system's individual components, such as software, may be regulated for safety, the entire telemedicine system is not necessarily evaluated objectively for its ability to safely provide diagnostic information.
Under the rubric of "telemedicine" falls a wide range of technologies and applications. This diversity poses a significant challenge to establishing standards for safe or efficacious practice, especially in light of the paucity of objective evaluative studies. Moreover, telemedicine technology is changing so rapidly that there are few formal standards or benchmarks to guide its use or technological development. This lack of standards has implications for telemedicine quality, safety, efficiency, effectiveness, privacy, investment and security. Since standards encompass such a broad range of telemedicine issues, we can only highlight some of those related to safety.
It is clear that the lack of educational and clinical practice guidelines as well as technical standards in telemedicine can lead to practices or situations that could adversely affect patient safety. For example, lack of technical standards can lead to the purchase of equipment that cannot communicate with other equipment and does not provide adequate images for clinical decision-making. Without appropriate technical standards, the accuracy of data that is compressed and decompressed in transmission may be compromised. Technical standards for telecommunications or equipment infrastructure also have implications for safety. For example, if the telecommunications infrastructure is not reliable and there are no redundancies built in, patients may be at risk if the system unexpectedly fails at a critical moment. Inadequate educational and clinical guidelines can result in poor training of practitioners whose grasp of modern information and telecommunications technologies is essential to quality care.
While most of the players in the telemedicine arena concur on the need for standards, there is less agreement on how to get there. It is hard to gain consensus, especially in the evolving field of telecommunications and with a variety of specialties involved in developing educational and clinical practice guidelines.
Given all these concerns, the Federal government has a legitimate interest in protecting the public from unsafe and untested medical technologies, while minimizing unnecessary regulatory delays in bringing to market life-saving or cost-saving technologies. The U.S. Federal Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is the lead agency with responsibility for protecting the public against unsafe medical devices. With respect to telemedicine, the FDA is responsible for ensuring the safety and effectiveness of telemedicine devices marketed in the United States. However, in telemammgraphy, the FDA plays a broader role.
The FDA's CDRH has prepared a White paper in response to a request from the JWGT entitled: "Telemedicine-Related Activities", that outlines its current telemedicine activities(1). The FDA has also sponsored a public forum to discuss the potential role of the FDA in the regulation of software for clinical decision making. The regulation of software is an area of controversy, with some arguing for a greater FDA role in assuring the safety of the public and others arguing that the FDA will stifle innovation.
This chapter will discuss the Federal regulatory role including device evaluation as well as the collaborative process that has heretofore helped to guide the use of new medical equipment. In addition, it will briefly touch upon some of the concerns arising from the lack of generally accepted standards in this field.
THE FDA REGULATORY ROLE
The FDA has the authority to regulate medical devices intended for human use.(2) However, the advent of telemedicine has created some new challenges for the agency. One of the first questions is whether telemedicine systems should be considered medical devices. The FDA defines a medical device 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: (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.
Broadly speaking, telemedicine systems fall within this definition. The FDA places all medical devices into a series of regulatory classes based on the level of control necessary to assure safety and effectiveness of the devices.(4) However, medical devices, including those used in telemedicine, vary widely in their complexity and degree of risk or benefits. Consequently, they do not all need the same degree of regulation.
To coordinate its telemedicine efforts, the FDA recently designated the Division of Reproductive, Abdominal, Ear, Nose, and Throat and Radiological Devices (DRAERD) to take the lead role in reviewing telemedicine devices. This gives manufacturers and professional organizations a central location within the agency to answer specific questions related to telemedicine devices. As with other medical devices, the regulatory process involves pre-market review of new or original devices, post-market surveillance, and quality systems assessment.
In December, 1996, the FDA proposed a classification for medical image management devices in the Federal Register. The proposal establishes a framework for the regulation of these devices and exempts some low-risk devices from certain regulatory requirements.
Of particular interest are Picture Archiving Communications Systems or PACS. Although most frequently associated with teleradiology, these systems have functions that are often the linchpin of most clinical telemedicine systems. PACS software organizes data files and provides image processing functions such as filtering (e.g., edge enhancement), measurement (e.g., distance, area and volume determinations), and special image (3D surface and volume rendering). These technical capabilities lie at the heart of most telemedicine systems that handle medical images. A summary of the proposed classification is available on the World Wide Web at: http://www.fda.gov/cdrh/fr1202as.html.
A SHARED ROLE
The FDA also works with other Federal agencies, health professional groups and manufacturers to encourage the development of technical standards, clinical guidelines and professional protocols for safety. Manufacturers and FDA representatives typically work together to develop standards for equipment construction and design that ensure safety in its use for health care.
The health care community is responsible for how equipment is used and how professional protocols and training are standardized. Physicians, nurses, and professional societies, such as the American College of Radiology (ACR), will typically establish standards that help guide the use of new equipment. As a result, the FDA plays a role of partner and ratifier by working with private sector groups to help set standards and guidelines. This applies to equipment standards, process standards (such as for developing software), and efforts to develop standard terminology for devices and procedures.
Although there has been slow progress on the clinical practice side in developing guidelines, some movement in the development of telemedicine technical communication standards has been made. One of the few breakthroughs in the image communication area is the creation of a uniform set of communication standards called DICOM (Digital Imaging and Communications in Medicine) by the American College of Radiology (ACR) and the National Electronic Manufacturers Association (ACR/NEMA).
In the area of health care informatics, several Federal Agencies are beginning to address standard issues. For example, the FDA and the Agency for Health Care Policy and Research (AHCPR) have been participating in an effort to coordinate health care informatics standards activities in the United States and to encourage international cooperation in related standards activities. Likewise, the National Library of Medicine (NLM) is heavily involved in sponsoring the development of data standards and uniform practices for effective transmission, aggregation, and integration of health care, public health and research data. And finally, Congress has turned its attention to this issue through the Kennedy-Kassebaum Health Insurance Portability and Accountability Act of 1996 by mandating the development and adoption of standards for electronic exchanges of health information for administrative purposes.(5)
Other agencies are beginning to test the technical reliability of telemedicine systems. Currently, the VA operates a laboratory to assess the efficacy and technical reliability of new health care technologies. Similarly, the Open Systems Laboratory at Lawrence Livermore Laboratories provides objective assessment of computer equipment. At the Department of Commerce, the National Institute of Standards and Technology (NIST) has an active program in conformance testing against industry standards. It develops test methods for software quality and measurement methods for electronics.
NEXT STEPS
Ensuring safety in telemedicine is a shared responsibility of the Federal government and private sector groups such as clinician organizations and equipment manufacturers. The FDA attempts to ensure a degree of safety through its device evaluation process. The agency also works with manufacturers and professional organizations to set standards for equipment and practice. However, the field of telecommunications and its application for health care is changing rapidly as new advances are made. The role of the Federal government in ensuring safety and effectiveness in telemedicine is still being defined. Some critics have charged that undue regulatory constraints may hamper development in this field. Others claim the FDA needs a more defined role to ensure the safety of patients being treated in telemedicine.
On an ongoing basis, the JWGT will work with the FDA, the FCC Advisory Committee on Telecommunications and Health Care as well as private sector groups to identify new issues of telemedicine safety and effectiveness concerns as they emerge. In addition:
The JWGT will explore the economic and logistic feasibility of expanding the efforts of the VA, NIST, and the Open Systems Laboratory at Lawrence Livermore Labs as well as others to provide a technical assessment capability of telemedicine technologies that would be available to all Federal agencies and their grantees. JWGT will also explore similar efforts in the private and public sectors with outside groups such as the HOST labs (Healthcare Open Systems & Trials), an organization of Federal, state university, and private sector laboratories.
Link: https://www.ntia.doc.gov/legacy/reports/telemed/safety.htm
Overview of Device Regulation
FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.
Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval. A description of device classification and a link to the Product Classification Database is available at "Classification of Medical Devices." The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:
Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA. All establishment registrations must be submitted electronically unless a waiver has been granted by FDA. All registration information must be verified annually between October 1st and December 31st of each year. In addition to registration, foreign manufacturers must also designate a U.S. Agent. Beginning October 1, 2007, most establishments are required to pay an establishment registration fee.
Medical Device Listing - 21CFR Part 807 Manufacturers must list their devices with the FDA. Establishments required to list their devices include:
Premarket Notification 510(k) - 21 CFR Part 807 Subpart E If a device requires the submission of a Premarket Notification 510(k), you cannot commercially distribute the device until you receive a letter of substantial equivalence from FDA authorizing you to do so. A 510(k) must demonstrate that the device is substantially equivalent to one legally in commercial distribution in the United States: (1) before May 28, 1976; or (2) to a device that has been determined by FDA to be substantially equivalent.
On October 26, 2002 the Medical Device User Fee and Modernization Act of 2002 became law. It authorizes FDA to charge a fee for medical device Premarket Notifcation 510(k) reviews. A small business may pay a reduced fee. The application fee applies to Traditional, Abbreviated, and Special 510(k)s. The payment of a premarket review fee is not related in any way to FDA's final decision on a submission. Most Class I devices and some Class II devices are exempt from the Premarket Notification 510(k) submission.
If you plan to send a 510(k) application to FDA for a Class I or Class II device, you may find 510(k) review by an Accredited Persons beneficial. FDA accredited 12 organizations to conduct a primary review of 670 types of devices. By law, FDA must issue a final determination within 30 days after receiving a recommendation from an Accredited Person. Please note that 510(k) review by an Accredited Person is exempt from any FDA fee; however, the third-party may charge a fee for its review.
Premarket Approval (PMA) - 21 CFR Part 814 Product requiring PMAs are Class III devices are high risk devices that pose a significant risk of illness or injury, or devices found not substantially equivalent to Class I and II predicate through the 510(k) process. The PMA process is more involved and includes the submission of clinical data to support claims made for the device. Beginning fiscal year 2003 (October 1, 2002 through September 30, 2003), medical device user fees apply to original PMAs and certain types of PMA supplements. Small businesses are eligible for reduced or waived fees.
Investigational Device Exemption (IDE) - 21CFR Part 812 An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification 510(k) submission to FDA. Clinical studies with devices of significant risk must be approved by FDA and by an Institutional Review Board (IRB) before the study can begin. Studies with devices of nonsignificant risk must be approved by the IRB only before the study can begin.
Quality System Regulation (QS)/Good Manufacturing Practices (GMP) - 21 CFR Part 820 The quality system regulation includes requirements related to the methods used in and the facilities and controls used for: designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices. Manufacturing facilities undergo FDA inspections to assure compliance with the QS requirements.
Labeling - 21 CFR Part 801 Labeling includes labels on the device as well as descriptive and informational literature that accompanies the device.
Medical Device Reporting - 21 CFR Part 803 Incidents in which a device may have caused or contributed to a death or serious injury must to be reported to FDA under the Medical Device Reporting program. In addition, certain malfunctions must also be reported. The MDR regulation is a mechanism for FDA and manufacturers to identify and monitor significant adverse events involving medical devices. The goals of the regulation are to detect and correct problems in a timely manner.
Link: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm