January 27, 2014

Recent FDA Medical Device Regulation and Its Relevance to Robotics

(Photo Credit AmSurg)

2014 seems poised to be the year of the robot, and some of the most exciting robotic applications appear in medicine.  Regulation can hinder or facilitate innovation in medical robotics.  The giant umbrella that is digital health – which includes telehealth systems, mobile health applications and devices, sensor-based technologies, big data and predictive analysis, genomics and wearables – will change the way consumers, providers, engineers and the legal system itself interact within the healthcare field.  This post covers the existing and evolving definitions used by the Food and Drug Administration (“FDA”) in considering medical device approval, a key consideration in bringing medical robots to market.

FDA Definitions: Medical Devices and Home Care Medical Devices

The FDA defines a medical device  as any product or equipment used to diagnose a disease or other conditions, to cure, to treat or to prevent disease. The FDA’s Center for Devices and Radiological Health (“CDRH”) regulates medical devices to provide reasonable assurance of their safety and effectiveness.

The FDA classifies medical devices into three categories -Class I, Class II, and Class III- based on the risks associated with the device. Where Class I devices (e.g. dental floss) are deemed to be low risk and therefore subject to the least regulatory controls (nominally, quality system regulation and the like), Class III devices (e.g. replacement valves) are considered the highest risk devices and typically require pre-market approval (“PMA”) on top of passing general controls. The classification of the medical device plays in determining whether the device is FDA-listed, 510(K) exempt, cleared or approved. A medical device is FDA-listed if the firm that manufactures or distributes the medical device has successfully completed an online listing for the device through the FDA Unified Registration and Listing System (“FURLS”). Some medical devices –mostly low-risk Class I and some Class II devices- do not require FDA review to provide a reasonable assurance of safety and effectiveness before the devices are marketed; these are considered 510(K) exempt (named for a section in the Food, Drug and Cosmetic Act, the “FD&C Act”). Cleared medical devices are ones that the FDA has determined to be substantially equivalent to another legally marketed device; a pre-market notification under the 510(K) should be submitted to the FDA for clearance.

Many medical robots have been classified as Class II medical devices, from the DaVinci surgical robotic systems (which received FDA 510(K) clearance in May 2001)and DigiMatch Robodoc Surgical System (an orthopedic computer controlled surgical system that registers the patient’s anatomy to a pre-operative surgical plan to guide a robotic arm during the milling of the femoral canal for primary total hip arthroplasty) to Remote Presence Robotic Systems (radiofrequency physiological signal transmitters and receivers), the RIO Robotic Arm Interactive Orthopedic System and the Armeo Robotic Arm exoskeleton.

A home care medical device is any product or equipment used in any environment outside of a professional healthcare facility by persons who are ill or have disabilities (for example, nebulizers, infusion pumps, blood glucose meters, etc.).

Changes in health care have moved care from the hospital environment to the home environment. As patients move to the use of home health care services for recuperation or long-term care, the medical devices necessary for their care have followed them.

The CDRH wants to decrease the number of problems that occur in the home environment, but issues are complex. In April 2010, the FDA launched the Medical Device Home Use Initiative to support the safe use of medical devices in the home. Through FDA’s efforts, additional information and resources for manufacturers, health care professionals, home care recipients, consumers, and caregivers have been and continue to be developed to encourage the safe use of medical devices in the home. As a result, the FDA has issued a draft guidance document for manufacturers recommending actions they should take to receive FDA approval or clearance of device intended to be used in the home. Included are steps that manufacturers can take to design and test devices for use in the home, and to develop user-friendly instructions (labelling) for home care recipients, consumers, and caregivers. The draft guidance is intended to improve the design and quality of home use devices to eliminate or reduce errors that occur during use.

Robots that assist with the logistics of health care and support “softer” human-robot interaction (“HRI”) tasks could fall into the category of home care medical device. While HRI tasks have been used to improve the medical conditions of patients, they have also been successfully applied to a range of tasks that do not directly address medical conditions. These latter applications of HRI -focusing on generic health and quality of life issues, as well as issues related to social care- are exemplified in robots like Cody (a robotic nurse developed by the Georgia Institute of Technology “gentle enough to bathe elderly patients), HERB (a CMU design which fetches household objects like cups and can even clean a kitchen) and Paro (a therapeutic robot that looks like a baby seal and is meant to have a calming effect, oft used on patients with dementia and Alzheimer’s). Back in 2009, Paro was certified by the FDA for use in the home by individuals, receiving a Class II exempt pre-marketing notification.

It is important to note that the FDA cannot and does not recommend specific medical devices for use in any setting. Review the instructions for use for a device you plan to use in the home before deciding on the one best for a particular patient population.

Mobile Medical Applications: FDA Definition and Oversight Approach

The FDA defines a mobile medical app as a software application that runs on a desktop computer, laptop computer, remotely on a website or cloud, or an a handheld computer that is intended for use in the diagnosis or the cure, mitigation, treatment, or prevention of disease, or to affect the structure of any function of the body.

In general, if a mobile app is intended for use in performing a medical device function, it is classified as medical device, regardless of the platform on which it is run. Take for example a mobile app that makes an LED operate. If the manufacturer intends the system to illuminate objects generally (i.e. without specific medical device intended use), then the mobile app would not be considered a medical device. If, however, through marketing, labelling, and the circumstances surrounding the distribution, the mobile app is promoted by the manufacturer for use as a light source for doctors to examine patients, then the intended use of the light source would be similar to a conventional device such as an ophthalmoscope and would be classified as medical device. A mobile medical app would therefore include, for example: mobile apps that use a sensor attached to the mobile platform or tools within the mobile platform itself to record, view or analyze eye movements for use in the diagnosis of balance disorders; and mobile apps that connect a nursing central station and display medical device data to a physician’s mobile platform for review.

The FDA’s oversight approach to mobile apps is focused on their functionality. The FDA will enforce regulatory oversight for those mobile medical apps that pose a high risk for patients and it will exercise enforcement discretion on those medical mobile apps that pose a low risk to the patients. For the latter, the FDA does not intend to pursue enforcement action for violations of the FD&C Act and applicable regulations.

The FDA intends to apply regulatory oversight for mobile apps such as Medical Device Data Systems (“MDDS”) and Regulated Medical Device Software. The latter encompasses software that performs patient-specific analysis and provides patient-specific diagnosis or treatment recommendations, such as calculating dosage. The first, MDDSs, include apps that are intended to display or store medical device data without controlling or altering the functions or parameters of any connected medical device; they do not  modify,  interpret,  or  add  value  to  the  data  or  the  display  of the data.

MDDSs are subject to Class I requirements, as the FDA believes that requiring general controls sufficiently manages the risk for mobile medical apps that are used as a secondary display to a regulated medical device and are not intended to provide primary diagnosis or treatment decisions. However, where the manufacturer intends  for  the  device  to  be  used  in  active  patient  monitoring and immediate clinical action is necessary,  the FDA requires a higher  classification. For example, a mobile app that uses the audio-video features of a smartphone to facilitate diagnosis or treatment in an intensive care setting is not an MDDS device, but rather a Class II device. InTouch Health’s Telemedicine Solution, the RP-VITA Remote Presence Robot was certified by the FDA as a Class II device in 2013, with 510(K) clearance. The RP-VITA combines telecommunication and autonomous navigation technology: AutoDRIVE capabilities allow RP-VITA to safely navigate and travel to select destinations without requiring user guidance for pre- and post-hospital medical consults; the ControlStation App enables fast and easy access and control from anywhere; and Cloud-based SureCoNNECT infrastructure maintains reliable connections under highly variable network conditions.

The FDA intends to exercise enforcement discretion for mobile apps that: help patients self-manage their disease without providing specific treatment or treatment suggestions; provide patients with simple tools to organize and track their health information; automate simple tasks for health care providers; enable patients to interact with Personal Health Record (“PHR”) or Electronic Health Record (“EHR”) systems; and generally provide or facilitate supplemental clinical are, by coaching or prompting, to help patients manage their health in their daily environment. The overarching principle here is that when mobile apps are marketed, promoted or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or otherwise meet the definition of medical device, the FDA intends to exercise enforcement discretion when those medical mobile apps pose a low risk to patients.

Daily Activity Assist Devices (“DAAD”) and Medical Reminders are examples of mobile apps where the FDA exercises enforcement discretion. DAADs include apps that are specifically marketed to help patients document, show, or communicate to providers potential medical conditions; such as videoconferencing portals specifically intended for medical use and to enhance communications between patients, healthcare providers, and caregivers. Medical Reminders are apps intended for medical purposes to provide alerts to patients or healthcare providers for pre-determined medical dosing schedules. Medical Reminder apps may incorporate wireless communication.

For more information on mobile medical apps, see the Guidance for Industry and FDA Staff on Mobile Medical Apps, issued September 25, 2013.

The FDA and the Future of Medical Devices

A vast number of medical robotic applications in the USA are in research and development or currently in the process of filing patent application. The FDA will have to classify devices that will be under the medical device category but will also: become more autonomous and intelligent -departing from the model of the daVinci system, which cannot be programmed nor make any decision on its own and requires that every surgical maneuver be performed with direct input from the surgeon-; and be remotely controlled over the internet and through Cloud computing, like InTouch Health’s Telemedicine Solution. The FDA’s speed and efficiency (including cost-efficiency) will determine if new devices will make it to the market in time to be competitive with EU initiatives like the European Community’s Framework Programme Seven, the Swedish Robotdalen, Toyota’s Care Assist Robot, and Japan’s HAL Cyberdyne.

The signs are optimistic: the FDA has shown to be a flexible body. In 2011, Jeffrey Shuren, head of the FDA’s office of medical devices, undertook to set in place a mechanism for expedited review, such that a FDA case manager guides the application and engineers have early access to senior agency scientists. Of course, devices accepted for speedy review must still meet all the safety standards, and limited money for fast-track reviews limit the evaluations to one or two products a year. In 2013, in light of Medtronic’s new technology and to deal with the medical devices available to diabetics, the FDA created a new categorical definition of a medical device: the Artificial Pancreas Device System (“APDS”). The FDA’s efforts to helping advance the development of APDS include prioritizing the setting of performance and safety standards, finding ways to shorten study and review time, and promoting greater communication between the FDA and manufacturers and researchers.

Innovative and emerging technologies are driving the regulatory process to become more flexible, and the FDA seems to understand that its role is crucial in the safe and efficient development of these devices.