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Regulatory Framework

Legal & Compliance

Effective: 1 June 2026Last updated: 1 June 2026

1. Nature and Regulatory Status

1.1 What Fesera Is and Is Not

Fesera is a digital health and wellness platform providing guided, self-administered, evidence-based rehabilitation content for adults with chronic non-specific low back pain. It is not a medical device, a clinical service, or a licensed healthcare facility.

Fesera does not

  • Diagnose medical conditions
  • Prescribe pharmaceutical treatments
  • Provide individual clinical consultations
  • Create a therapeutic relationship with users
  • Operate as a hospital or licensed clinic

Fesera does

  • Provide clinician-designed movement protocols
  • Use validated tools to screen for safety red flags
  • Classify pain patterns to personalize general programs
  • Provide evidence-grounded educational content
  • Prompt users to seek professional care when indicated

1.2 Is Fesera a Medical Device?

The answer, under current applicable frameworks across all our markets, is no. Here is the reasoning:

  • IMDRF SaMD Framework: The International Medical Device Regulators Forum (IMDRF) distinguishes between software that informs clinical management of an individual (regulated as SaMD) and software that provides general wellness information (not SaMD). Fesera provides a structured exercise programme for a population that has self-screened, positioning it as a general wellness tool.
  • Nigeria (NAFDAC): Nigeria's regulatory framework for software-based digital health tools is developing. Fesera is not currently required to register as a medical device with NAFDAC.
  • European Union (EU MDR 2017/745): Under MDCG 2019-11, general wellness software is not a medical device. Fesera falls into the general wellness category.
  • United Kingdom (MHRA): Fesera's wellness and self-rehabilitation positioning aligns with MHRA's distinction between medical device software and general wellness tools.
  • United States (FDA 21st Century Cures Act): Fesera falls within the enforcement discretion category for low-risk software that helps users self-manage a condition without providing specific treatment suggestions.

1.3 Nigerian Regulatory Compliance Summary

RegulationCompliance Status
NDPA 2023 (Data Protection)Compliant (See Privacy Policy)
FCCPA 2018 (Consumer Protection)Compliant transparent pricing and honest representations
NAFDAC Act (Medical Devices)Wellness software classification; active regulatory tracking
PCN ActNot a clinical practice; educational content only
CBN Payment RegulationsCompliant via Paystack payment engine

2. Clinical Safety Framework

Fesera operates on a clinical safety first principle, with multiple gates built into the assessment and architecture:

  1. Red Flag Screening Gate: Mandatory screening before any exercise protocol is recommended. Positive screens redirect users to emergency medical evaluation.
  2. Condition Scope Gate: Tailored exclusively for chronic non-specific low back pain.
  3. Pain Response Telemetry: Daily check-in scores modify daily session intensity or trigger Rest advisories via a deterministic rules engine.
  4. In-Programme Red Flag Prompts: Urgent advisories if new symptoms emerge during check-ins.
  5. Phase Progression Gates: Users cannot progress without meeting defined clinical readiness criteria.

2.1 Contraindications

The programme is not appropriate for individuals with any of the following conditions:

  • Active cancer or recent malignancy affecting the spine or adjacent structures
  • Vertebral fracture (including osteoporotic compression fracture)
  • Spinal infection (osteomyelitis, discitis, epidural abscess)
  • Cauda equina syndrome
  • Severe or rapidly progressive neurological deficit
  • Ankylosing spondylitis or other inflammatory spondyloarthropathy requiring active management
  • Recent spinal surgery without clearance from the treating surgeon (typically 6-12 weeks)
  • Unstable cardiovascular condition contraindicating moderate physical activity

3. Professional Basis and Clinical Credentials

Fesera protocols are designed by licensed physiotherapists and informed by established, peer-reviewed clinical research:

Tool / FrameworkApplication in Fesera
STarT Back Screening Tool (Keele University)Psychosocial risk stratification
McKenzie Method (MDT)Directional preference testing
McGill MethodCore endurance ratios & spine-sparing mechanics
Cochrane Collaboration (2021)Evidence base for active movement therapy
ICD-10 M54.5Condition scope definition

Note: Fesera is not formally affiliated with or accredited by the McKenzie Institute or any McGill-affiliated body. These frameworks are referenced based on published academic literature.

4. Platform Transparency: No AI Diagnosis

Fesera's classification and pain-response systems are rule-based algorithms, not artificial intelligence or machine learning. No user data is fed into a proprietary AI model for diagnostic purposes. All programme decisions, classification, progression, and session modification are based on deterministic clinical logic reviewed and approved by a licensed physiotherapist.

5. Medical Disclaimer

All content on the Fesera platform is provided for self-guided educational and movement rehabilitation purposes only. It does not constitute medical diagnosis or individual clinical treatment. Always consult a qualified physician if you experience severe symptoms or red flag conditions.

6. Contact for Legal and Compliance

For compliance or legal questions, reach out to our team: