Medical Device Compliance & Regulatory Newsletter January 2026

Key Highlights of the Guidance

1. Scope of General Wellness Products

• Products aimed at maintaining or encouraging general health (e.g., weight management, fitness, relaxation, sleep, self-esteem, sexual function).
• Products referencing chronic disease risk reduction or living well with chronic conditions, supported by well-accepted scientific evidence (e.g., physical activity reducing hypertension risk, healthy diet supporting diabetes management).

2. Low-Risk Criteria

To qualify under this policy, products must:

• Be non-invasive (not penetrating the skin or mucous membranes).
• Not be implanted.
• Avoid risky technologies (e.g., lasers, radiation, neurostimulation).
• Avoid claims suggesting diagnosis, treatment, or medical management.

3. Regulatory Discretion

• The FDA’s Center for Devices and Radiological Health (CDRH) does not intend to enforce device requirements such as registration, premarket notification, labeling, QMS, or MDR for low-risk general wellness products.
• Products classified as medical devices (e.g., blood glucose monitors, ECG devices) must comply with full regulatory requirements.

4. Examples Provided

• Not considered devices: music apps for relaxation, fitness trackers, diet logging software, exfoliation tools for cosmetic use.
• Considered devices but not enforced: non-invasive wearables tracking pulse rate, oxygen saturation, or sleep patterns, marketed strictly for wellness.
• Excluded from low-risk category: invasive microneedle glucose monitors, tanning lamps, cosmetic implants, neurostimulation devices.

Industry Implications

• Digital Health & Wearables: Enables innovation for fitness trackers, sleep apps, and stress management tools when claims remain wellness-focused.
• Marketing & Labeling: Claims referencing diagnosis, treatment, or medical accuracy may trigger full device regulation.
• Quality Management Transition: Notes the transition from QSR to QMSR effective February 2, 2026, aligning with ISO 13485.
• Borderline Products: Products measuring physiological parameters must validate outputs and limit claims to wellness contexts.

Takeaway

The FDA’s updated guidance supports innovation in wellness technologies while protecting consumers from risky or misleading claims. Manufacturers should remain within wellness boundaries unless prepared to meet full medical device regulatory requirements.

As wearables and digital health tools continue to grow, alignment with this guidance will help companies innovate confidently while avoiding compliance risks.

Final Thought: Regulatory clarity sustains trust in the wellness-tech sector. This guidance draws a clear line between wellness innovation and medical device regulation.

Understanding the FDA's 2026 Guidance on Clinical Decision Support (CDS) Software

On January 6, 2026, the FDA issued updated guidance on Clinical Decision Support (CDS) Software, replacing the 2022 version. The guidance explains how the FDA interprets Section 520(o)(1)(E) of the FD&C Act to determine whether CDS functions are regulated as medical devices or qualify as Non-Device CDS.

Highlights of the 2026 Guidance

• Clarifies when CDS functions are excluded from the medical device definition under Section 520(o)(1)(E).
• Defines four statutory criteria for Non-Device CDS, focusing on data inputs, transparency, and clinician oversight.
• Emphasizes that CDS must support, not replace, clinical judgment.
• Provides examples distinguishing Non-Device CDS from Device CDS.
• Aligns with broader digital health policies and global regulatory trends.

Examples

Non-Device Clinical Decision Support

• Tools predicting risk using patient demographics and laboratory data.
• Treatment plan generators reviewed and finalized by healthcare professionals.

Device Clinical Decision Support

• Software interpreting ECG waveforms, genetic data, or continuous glucose monitor signals.
• Computer-assisted diagnostic systems analyzing medical images.

Importance

The guidance brings clarity to developers, regulators, and healthcare providers navigating AI-driven decision support. It promotes transparent and explainable CDS while safeguarding patient safety.

For developers, transparency in data sources and context is critical. For healthcare providers, the guidance clarifies when CDS tools function as support aids versus regulated devices.

Conclusion

The FDA’s 2026 CDS guidance marks a significant shift in digital health regulation. By clearly distinguishing Device CDS from Non-Device CDS, the FDA provides a structured framework for responsible and scalable innovation.

At Sushvin Consultancy, we assist clients in navigating these regulatory changes and comparing them with EU and UK frameworks.

For guidance, visit: https://lnkd.in/ghhvbEec

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The Therapeutic Goods Administration (TGA) has revised its guidelines for sponsors seeking consent to supply medical devices that do not fully comply with the Essential Principles (EPs). This approach ensures access to critical devices while maintaining patient safety.

Background

Under the Therapeutic Goods Act 1989, it is illegal to import, supply, or export medical devices that do not meet one or more Essential Principles. However, the TGA may grant temporary consent in exceptional circumstances if specific conditions are met.

• Safety and performance risks are mitigated.
• The benefits of continued supply outweigh the risks.
• The device is essential for patient care and no suitable alternatives are available.

What Consent Covers

• Medical devices and IVDs temporarily failing one or more Essential Principles.
• Exempt devices, such as vaping devices.
• Stock held overseas, onshore, or by the sponsor.

What Consent Does Not Cover

• Permanent supply of non-compliant devices.
• Devices already supplied to hospitals, distributors, or patients.
• Situations where risks cannot be adequately mitigated.
• Cost-saving measures such as over-labelling.
• Lapsed conformity assessment certificates.

Requirements

Sponsors must submit applications through the TGA Business Services portal. Applications must include the following information:

• Identification of unmet Essential Principles.
• Batch or lot numbers and supply volumes.
• The requested consent period.
• An explanation of the circumstances leading to non-compliance.
• Risk mitigation strategies and timelines to restore compliance.
• Evidence of market action, if applicable.

Applications are assessed on a case-by-case basis, with no fixed review timelines. Approval depends on the quality and completeness of the submission.

When to Apply

• A life-saving device has a defect with potential risks and no available alternatives.
• Instructions for Use (IFU) updates are delayed, requiring temporary consent for existing stock.

When Not to Apply

• Labels missing a warning that can be corrected through over-labelling before supply.
• Devices with expired conformity assessment certificates that still meet the Essential Principles.

Implications for Industry

• Audit Readiness: Sponsors must maintain detailed records of market actions and consent applications.
• Risk Management: Robust mitigation plans are critical for approval.
• Continuity of Care: Consent supports uninterrupted access to essential devices during temporary compliance gaps.
• Financial Considerations: Fees apply, with reduced charges for EP 13 (labelling) and EP 13A (patient information materials).

Conclusion

The updated guidance provides clearer structure for sponsors managing temporary non-compliance. It reinforces the TGA’s focus on patient safety while ensuring continuity of supply for essential medical devices.

At Sushvin Consultancy, we support sponsors in navigating complex regulatory pathways such as the TGA’s consent to supply process, ensuring compliance and sustained patient access.

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