FDA Regulation & Advancements in Medical Device Technologies

Medical devices are instruments, apparatuses, machines, their accessories or components used to diagnose, treat, mitigate disease or abnormal conditions, affect body function or structure and include implants, in vitro diagnostic (IVD) test systems, imaging devices, computer systems like picture archiving & communication systems (PACs) & data management systems. 

Medical Device Consulting Services

For those interested in the US medical device market, such as US manufacturers, foreign manufacturers / exporters or their US representatives, laboratories, specification developers, re-packagers / re-labelers, we provide a full suite of regulatory, quality and safety reporting services.

 

We ensure the regulatory compliance of your medical device over its entire life cycle, pre and post market. Whether it be engaging in FDA meetings, filing regulatory submissions such as investigational device exemptions (IDEs) for clinical investigations, premarket notification/approval (510(k)/PMA) or de novo submissions for FDA market clearance, amendment submissions, clinical consulting, clinical trial registrations with ClinicalTrials.gov, quality system design and management, reporting of adverse events, corrections or removals, labeling compliance, export permits or facility registration and listing, we are with you every step of the way. Our clinical consulting services may include supporting clinical trial sponsors with study design, the preparation of investigator brochures, informed consent declarations, and institutional review board (IRB) guidance for FDA compliance. For instance, we critique a study design from a regulator’s perspective to support the safety and / or effectiveness of the product. We can also guide IRBs on determining investigator-study suitability, financial / ethical considerations and alert IRBs to study design features or characteristics that may significantly increase potential risks to subjects.

 

By keeping at the forefront of regulatory developments by the Food and Drug Administration (FDA), we design regulatory strategies specific to your medical device to optimize product safety and performance, to facilitate market approval and reduce company cost.  The regulatory strategies and the regulatory pathway employed are determined in consultation with our customers and vary as customer objectives, budgets and the medical device in question changes with time. At all times, we choose the least burdensome, cost optimal route to regulatory compliance. For instance, if on consultation with a manufacturer and device records, we determine that a moderate risk class II device already complies with FDA recognized standards or with appropriate design controls, we would recommend the abbreviated 510(k) or the special 510(k), respectively, instead of the traditional 510(k) submission type to accelerate the market approval process.

 

A high risk class III device manufacturer that is in the process of gathering performance data may opt for a combined IDE-modular PMA process where the regulatory submission is reviewed in parts or modules by the FDA. If a class III device is well known for its technology and use, a manufacturer may opt for the streamlined PMA route. A seemingly low risk class I or moderate risk class II medical device due to its innovative technology or use can be unclassified / outside of any existing FDA device regulation panel with no comparative legally marketed predicate device for demonstration of substantial equivalence under the premarket 510(k) submission process. For such a device, we would recommend the de novo regulatory pathway as the fastest route to market.  

Regulatory and Device Technology Advancements

We keep on the cutting edge of medical device technology and associated regulatory advancements to provide quality service to our customers. Previously, medical devices were used in clinics or hospitals under direct supervision by a healthcare professional. However with advancements in technology, medical devices are now including home use devices, wireless technologies, medical mobile apps and companion diagnostics in personalized medicine. Currently, among global regulatory agencies, the US FDA seems to be leading the way in adjusting the regulatory landscape to cater to device innovation.

Home Use Devices

Home use devices are medical devices for use in an environment outside of a professional healthcare facility where personnel with medical training continually oversee / administer the use of medical devices. Examples of professional healthcare facilities include hospitals, long-term care facilities, nursing homes, emergency medical services, clinics, physicians’ offices, and outpatient treatment facilities; or clinical laboratories.

 

There are several human factors considerations to be made during development for FDA clearance / market approval of home use medical devices. These include varying environmental considerations (e.g. contamination potential, temperature, humidity, water supply, atmospheric pressure, airflow, location, travel, international use), user considerations (e.g. users with a range of physical, sensory / perceptual, cognitive, emotional capabilities / disabilities), design considerations (e.g. lock out mechanisms, maintenance, calibration, mechanical / electrical issues), labeling (e.g. emergency handling, disposal) and post market considerations (e.g. customer service, medical device problem reporting). Based on the nature of the medical device and intended use, we provide valuable consulting advice, cost-effective strategies and recognized standards for regulatory compliance / market approval of home use devices.

Wireless Technologies

Radio frequency (RF) wireless medical devices use wireless RF communication for functions such as patient data transfers, device control and programming or remote patient monitoring to support health care delivery. Today, RF wireless medical devices are implanted, worn on the body or are external and intended for use in hospitals, homes, clinics, clinical laboratories, and blood establishments.

 

We work with manufacturers to develop a risk based approach for the entire device life cycle to attain FDA market authorization and maintain the product on the market. Our consulting advice begins with the selection of the wireless technology and continues into design verification and validation testing, performance evaluation, risk mitigation and ongoing maintenance. We help manufacturers assure FDA of an acceptable wireless quality of service (QoS), wireless coexistence, the security of wireless signals and data, electromagnetic compatibility (EMC) of the wireless technology, acceptable labeling for user set up & operation and servicing / maintenance mechanisms.

 

We additionally support healthcare facilities in promoting EMC and preventing electromagnetic interference (EMI). This can include consultation on recognized standards, co-ordination for training, risk assessment and mitigation activities, documentation of procedures / policies and reporting of EMI problems to FDA and the scientific community.

Medical Mobile Apps

Medical mobile apps are smartphone / mobile communication device software and / or accessories thereof that are used as medical devices, are accessory to a medical device or transform a mobile platform into a regulated medical device. Mobile medical apps can be mobile platforms that include software / hardware components or commercial off the shelf (COTS) software offered through web subscription, software as a service or other similar means. The risk classification and regulation of the medical mobile app determines the regulatory requirements and medical device consulting services needed (described above).

 

There are other kinds of mobile apps used in the health care industry that may not be clearly regulated by FDA as medical mobile apps but are subject to FDA enforcement discretion since they may be medical devices. Our consulting services help mobile app designers, developers, manufacturers and labelers distinguish between mobile apps clearly regulated by FDA (i.e. a medical mobile app), mobile apps subject to FDA enforcement discretion and mobile apps used in health care that are not medical devices.

Personalized Medicine and Companion Diagnostics 

Personalized medicine is the tailoring of medical treatment to the characteristics, needs, and preferences of a patient during all stages of care, including prevention, diagnosis, treatment, and follow-up. Regulatory agencies like FDA and industry are increasingly focused on personalized medicine as a solution to problems in health care. One example of personalized medicine is the employment of companion diagnostics. A companion diagnostic is often an in vitro diagnostic device essential for the safe and effective use of a corresponding therapeutic product (e.g. pharmaceutical / biologic drug).

 

Companion diagnostics may monitor patient responses in order to optimize treatment (e.g. dose) or may identify patients likely to benefit from / are at risk of experiencing serious adverse reactions to the therapeutic product. Companion diagnostics and their corresponding brand and generic therapeutic products require special labeling to reflect the essential nature of the combination for patient safety and / or effectiveness. In addition to labeling consultation, we support manufacturers of both the device and the drug with all their compliance needs at every stage of the product life cycle whether it be early design consultation, clinical / investigational and market authorization applications, post market safety reporting, modification or re-innovation of the product.

 

In conclusion, as medical device technologies advance, the regulatory landscape is evolving for their inclusion, increasing in clarity and / or becoming specialized by product category. The above technologies are just a few examples. By keeping abreast of the evolving regulatory landscape, we provide a comprehensive suite of regulatory, quality and safety consulting services for medical devices even at cutting edge of technology.