Regulatory Landscape - Overview

Non-invasive Device Regulatory Landscape: Product Overview

Non-invasive devices are medical tools used to diagnose, monitor, or treat health conditions without the need to be implanted to penetrate the skin or body of the patient using it, these devices work externally not involving penetration into tissues or body cavities, without hurting the patient.

Non-invasive Device Types:

Non-invasive devices used to monitor or treat various health conditions include cardiac monitors, blood pressure monitor, anesthesia monitor, electrocardiogram monitor, brain monitor and blood glucose monitor.

Non-invasive Device Applications:

Non-invasive medical devices have become essential tools in modern healthcare, offering accurate and continuous monitoring of various physiological parameters without the need for invasive procedures. These devices are used in a wide range of applications.

• Pulse oximetry measures blood oxygen levels and pulse rate, which is vital for respiratory monitoring and during anesthesia.
• Blood pressure monitors track systolic and diastolic blood pressure, crucial for managing hypertension and cardiovascular health.
• Electrocardiograms (ECGs) record the heart's electrical activity, diagnosing conditions like arrhythmias and heart attacks. Core temperature measurement through the bladder is important in critical care settings.
• Wearable glucose monitors measure blood sugar levels through skin or sweat, benefiting diabetes management without daily pricks.
• Neurological monitoring devices detect brain activity, seizures, and assess brain function in stroke or trauma patients, used in intensive care and neurosurgery.
• Respiratory monitoring devices, such as pulse oximeters and digital thermometers, measure breathing rate, oxygen saturation, and temperature, identifying respiratory distress and monitoring respiratory conditions.
• During the COVID-19 pandemic, non-invasive monitoring devices played a crucial role in critical care centers, monitoring patients' recovery and managing their health status effectively.

These applications highlight the versatility and importance of non-invasive devices in improving patient care and outcomes across various medical conditions.

Non-invasive Device Product Development steps:

Figure: FDA Regulatory Framework for Non-Invasive Devices

Non-invasive Device Market Size Overview:

The Non-Invasive Monitoring Device market is projected to reach USD 2.1 Billion by 2032 at 5.1% CAGR during the forecast period 2023-2032.

Non-invasive Device Regulatory Landscape:

There are several key regulatory agencies who oversee the approval and monitoring of Non-invasive Device to ensure their safety, efficacy, and quality.

Non-invasive Device Guidelines:

Non-invasive devices are utilized in a broad range of medical conditions; they are used by healthcare professionals as well as patients depending on device purpose and regulatory guidelines. Most of the non-invasive devices like digital thermometers, blood pressure monitors, and wearable fitness trackers are user friendly and can be used by patients at home, for self-monitoring of health parameters such as blood pressure, glucose levels, oxygen saturation and heart rate. It is most effective for patients with conditions like diabetes, hypertension, cardiovascular disorders to manage their health in better way allowing continuous or routine monitoring.

Non-invasive Device Classification of the Product:

Non-invasive Device Regulatory Process Overview, By Country:

The center for devices and radiological health (CDRH) is responsible for the regulation of all the medical devices including the non-invasive devices used for treatment or monitoring of various health conditions under food and drug administration (FDA), to ensure the safety, efficacy and quality of the medical devices used in healthcare systems.

FDA has issued guidance documents to outline the regulatory policies for the regulation of non-invasive devices used in patient care. Key regulatory requirements for these devices are as follows:

Device classification: non-invasive devices are classified into class I (low risk) , class II (moderate risk) and class III (high risk) devices based on the risk they may pose to the patient using it.

Premarket notification 510(k): Class II devices are subjected to premarket Notification 510(k) demanding substantial equivalence evidence to legally marketed predicate device. manufacturers must submit 510 (k) notification and obtain FDA clearance before marketing, unless device is 510 (k) exempt.

Premarket Approval (PMA): Class III devices are subjected to Premarket Approval (PMA), involving strict FDA review and are considered to be devices used for life threatening health conditions.

Labelling requirements: Medical devices must include updated labelling with clear explanation of new functions or indications, with device performance data and risk details, instructions suitable for home use, written in layperson friendly language.

Compliance with quality system regulations: manufacturers must document and validate all changes under quality system regulation (21 CFR part 820). Procedures must be in place for design changes, risk assessment and verification.

Cybersecurity requirements: Medical Devices involving modifications enabling connectivity (e.g. for data transmission) must adhere to cybersecurity. They must follow FDA cybersecurity guidelines for both premarket and postmarket management. adherence to recognized standards like IEC 62304, UL 2900, ANSI/UL 2900-2-1 First Edition 2017 – Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems, etc.

Post market surveillance: FDA monitors the devices even after approval of the product and its sale in the market to ensure continued safety, effectiveness and quality of the devices through medical device reporting (MDR). Any adverse event is found related to the marketed product they immediately initiate or oversee product recall.

Few examples of non-invasive remote monitoring devices along with its medical device class and regulatory pathway involved in approval process are as follows;

Non-invasive Device updates:

March 2025, The FDA has granted Breakthrough Device designation to the XCSITE platform, a non-invasive brain stimulation device developed by Flavio Frohlich, PhD, at the UNC School of Medicine, to treat Major Depressive Disorder (MDD). This innovative device, created by Pulvinar Neuro, a neurotechnology company founded by Flavio Frohlich, uses weak electrical currents to alter brain waves associated with depression, detected through an electroencephalogram (EEG). Clinical trials have shown that the device significantly reduces symptom severity, with 80% of participants declared free of clinical depression symptoms of two weeks post-treatment. The designation aims to expedite the device's market entry, providing rapid and personalized treatment options for depressive symptoms. This approach is significant as traditional treatments for depression, such as psychotherapy and medications, are not always effective and can be challenging for patients to adhere to. The Breakthrough Devices Program supports faster market access for transformative technologies, ensuring timely availability of advanced treatments for life-threatening or debilitating conditions.

Non-invasive Device Regulatory Challenges and possible risk in development:

Regulatory Differences: Different countries have varying regulatory frameworks, which can lead to delays in the approval and market entry of new medical devices. This "medical device lag" affects patient access to innovative technologies. The absence of a unified global regulatory standard means that manufacturers must navigate multiple regulatory systems, increasing the time and cost of bringing new devices to the market.

Complex Approval Processes: The increasing complexity of medical devices requires more strict evaluation, which can slow down processes. Strict regulatory requirements can affect innovation by making it more difficult for new technologies to reach the market.

Technical challenges: In terms of development risks, non-invasive devices must ensure accuracy and reliability without compromising patient safety. The need for continuous monitoring and data accuracy poses technical challenges, especially in devices like wearable glucose monitors and neurological monitoring systems.

HIPAA compliance: Ensuring data privacy and security is also critical, as these devices often collect sensitive health information.

Non-invasive Device Competitive Landscape Dashboard:

Companies With Marketed Non-invasive Device:

• Advanced Brain Monitoring
• General Electric
• medical
• Medtronic
• CNSystems Medizintechnik 
• Philips
• Integrity Applications
• Abbott
• Tensys Medical
• Omron
• A&D Medical
• Vaso Corporation
• CAS Medical Systems