Preparing Regulatory Strategy for Novel, New, and Next-Generation Medical & IVD Devices

In the fast-paced world of medical and in vitro diagnostic (IVD) devices, the development of novel, new, and next-generation products comes with the unique challenge of navigating complex regulatory landscapes. Crafting an effective regulatory strategy is not just about compliance—it’s about ensuring that your product reaches the market efficiently while maintaining patient safety and public trust.

Here, we explore the key aspects of developing a robust regulatory strategy, with a focus on using proper terminology that aligns with global regulatory expectations.

Understand Regulatory Classifications

The first step in your regulatory strategy is to accurately classify your device. This requires using correct and precise terms, as these determine the regulatory requirements your product must meet.

• Novel Devices: Products with no predicate or existing equivalent in the market. Highlight features that are first-of-its-kind while ensuring clear descriptions of their intended use.
• New Devices: Devices that are introduced with incremental improvements or new indications for use, but with a predicate device available for comparison.
• Next-Generation Devices: Products with significant advancements in technology or functionality, often building on the performance of earlier iterations.

Correct classification helps define the applicable regulatory pathway, whether it's a 510(k) submission, PMA (Premarket Approval), or a De Novo classification for U.S. FDA, or CE marking under MDR for the EU or New Device Approval under CDSCO by Clinical Investigation.

Adopt Standardized Terminology in Submissions

Regulatory bodies expect consistent, standardized terminology to describe device functions, mechanisms, and benefits. Using terms from international standards such as ISO 13485 and IEC 60601 ensures clarity and conformity. Examples include:

• For IVDs, refer to terms in ISO 20916 for performance evaluation.
• Use harmonized symbols and terms recognized in ISO 15223-1 for labeling.
• Clearly differentiate between diagnostic, screening, and monitoring in IVD device descriptions.

How and When use to use Novel, New, and Next-Generation for your device

Choosing the correct term—Novel, New, or Next-Generation—to describe your medical or in vitro diagnostic (IVD) device is crucial for regulatory submissions, marketing materials, and stakeholder communication. Misusing these terms can lead to misunderstandings or delays in regulatory approvals. Below is a guide to understanding and applying these terms appropriately.

1. Working Principle

Definition:
The working principle of a medical or IVD device describes the fundamental scientific or engineering concept underlying its functionality. This provides the theoretical foundation that explains how the device achieves its intended purpose.

Example in Medical Devices:

• The working principle of an MRI scanner is based on nuclear magnetic resonance (NMR), where hydrogen atoms in the body align with a magnetic field and emit signals used to construct detailed internal images.
  Example in IVD Devices:
• The working principle of an ELISA test relies on the interaction between antigens and antibodies, with a detectable enzymatic reaction signaling the presence of the target analyte.

2. Principle of Operation

Definition:
The principle of operation describes how the working principle is applied in practice through the design and functionality of the device. It outlines the steps or mechanisms the device uses to execute its intended purpose.

Example in Medical Devices:

• In an infusion pump, the principle of operation includes using a peristaltic mechanism to deliver a precise volume of fluid to the patient at a controlled rate.
  Example in IVD Devices:
• For a PCR device, the principle of operation includes thermal cycling to amplify DNA, followed by real-time fluorescence detection of amplified sequences. 

3. Mechanism of Action

Definition:
Often used interchangeably with working principle, this term is more common when discussing therapeutic or diagnostic agents. It refers to how the device or drug interacts with biological systems to achieve its effect.

Example:

• The mechanism of action of a pacemaker involves delivering electrical impulses to the heart to regulate its rhythm.

4. Mode of Action

Definition:
This term is specifically used in regulatory contexts to describe the primary means by which a device achieves its therapeutic or diagnostic effect. It is crucial for classification and regulatory approval.

Example:

• A mechanical ventilator’s mode of action is classified as providing respiratory support through controlled airflow to the lungs.

5. Intended Use vs. Indications for Use

Intended Use:
Defines the general purpose of the device, specifying what it is meant to do.
Example:

• A blood glucose meter’s intended use is to measure blood glucose levels in diabetic patients.

Indications for Use:
Outlines the specific medical conditions, patient populations, or clinical scenarios the device is designed for.
Example:

• A blood glucose meter is indicated for diabetic patients requiring regular glucose monitoring.

6. Key Supporting Terms

Functionality

Describes the specific tasks or outputs a device performs, highlighting its operational capabilities.
Example:

• The functionality of a pulse oximeter is to measure oxygen saturation and pulse rate.

Technical Specifications

Provides the measurable parameters and features that define a device’s operational limits and capabilities.
Example:

• For a CT scanner, specifications include slice thickness, spatial resolution, and radiation dose.

Clinical Performance

Refers to the effectiveness and safety of a device in actual clinical use, often validated through trials or post-market surveillance.
Example:

• The clinical performance of an IVD test kit is assessed by sensitivity, specificity, and reproducibility metrics.

Application in Documentation

When documenting for medical and IVD devices, these terms are typically detailed in:

• Technical Files or Design Dossiers (for regulatory submission).
• User Manuals (for end-user guidance).
• Clinical Evaluation Reports (to validate safety and performance).

Novel Devices typically disrupt existing paradigms, requiring new regulatory pathways, extensive clinical testing, and potential reclassification efforts.

New Devices build on existing frameworks but introduce significant updates or address unmet clinical needs.

Next-Generation Devices refine the usability andperformance of established technologies, offering incremental yet impactful improvements.

Terms	Definition	Terms Associated with Classification
Novel Devices	Devices that are based on entirely new scientific principles, mechanisms of action, or technologies that have not been previously utilized.	Working Principle: The device introduces a new, untested scientific or engineering concept. Mechanism of Action: Completely new way of interacting with biological systems. Clinical Performance: Unknown or unpredictable outcomes requiring extensive validation. Regulatory Status: No predicate or comparable device exists for regulatory approval.
New Devices	Devices that modify or improve an existing technology, mechanism, or application but retain fundamental similarities to previous devices.	Principle of Operation: Modified implementation of an existing working principle. Functionality: Enhanced or additional functions added to existing technology. Technical Specifications: Improvements in accuracy, sensitivity, or efficiency. Indications for Use: Expanded to new patient populations or conditions, without fundamentally altering the intended use.
Next-Generation Devices	Devices that represent iterative advancements or refinements of existing products, focusing on improved performance, usability, or safety.	Mode of Action: Maintains the same action but optimizes delivery or performance. Functionality: Incorporates state-of-the-art components for better user experience. Technical Specifications: Upgrades to meet higher industry standards (e.g., better resolution, faster processing). Clinical Performance: Demonstrates incremental improvements validated through clinical studies.

Align with Global Regulatory Frameworks

Each regulatory body has specific terminologies and requirements:

• FDA: Focuses on "substantial equivalence" for new devices under 510(k). Clearly define terms like "clinical benefit," "real-world evidence," and "innovative technology."
• EU MDR/IVDR: Emphasizes “state of the art” and “scientific validity.” Use terms aligned with these regulations to describe device functionality and intended use.
• WHO Prequalification: For global IVD distribution, align terms like “public health need” and “assay performance” with WHO guidelines.

Regulatory Pathway Examples

• Novel Devices: Require a de novo classification (e.g., FDA De Novo) or PMA due to the absence of predicates.
• New Devices: Can often leverage existing regulatory pathways like the 510(k) or EU MDR Class IIa/IIb route, Notified Device approval (CDSCO).
• Next-Generation Devices: Typically follow existing pathways but may need additional evidence to demonstrate improved safety or performance.

Using precise language helps map out a clear regulatory pathway:

• For novel devices, define unmet clinical needs and justify the device's innovative claims.
• For next-generation devices, focus on how advancements improve patient outcomes or reduce risks.
• For new devices, highlight iterative changes while showing alignment with existing regulatory frameworks.

It is always emphasized to choose correct terms for ideal launch of new devices to plan your regulatory pathway.