Intended Use

Intended Use (also called "intended purpose" in EU terminology) is the manufacturer's objective intention regarding the use of a medical device, including the medical indication, patient population, part of the body or type of tissue applied to or interacted with, and clinical effect. The intended use is fundamental to medical device regulation, as it determines whether a product is a medical device, its risk classification, applicable regulatory pathway, and requirements for evidence.

Regulatory significance:

Determines if product is a medical device:
- Medical device definition centers on intended use/purpose
- If intended for medical purposes (diagnosis, prevention, treatment, monitoring), likely a medical device
- If intended for general wellness or non-medical purposes, may not be regulated as medical device
- Manufacturer's stated intent is primary factor, but actual marketing and use also considered

Determines device classification:
- EU MDR Classification Rules based on intended use (duration, invasiveness, body part)
- FDA classification based on intended use and technological characteristics
- Higher risk intended uses result in higher classifications (Class III vs. Class I)
- Changes to intended use can change classification

Determines regulatory pathway:
- Intended use dictates evidence requirements (clinical evaluation, performance testing)
- Affects submission type (510(k), PMA, CE marking route)
- Determines predicate device eligibility for substantial equivalence
- Influences review timeline and regulatory scrutiny level

Key components of intended use statement:

1. Medical indication:
- Disease, condition, or state being diagnosed, treated, prevented, or monitored
- Example: "For the treatment of Type 2 diabetes" or "For diagnosis of bacterial infections"

2. Patient population:
- Age groups (pediatric, adult, geriatric)
- Gender if relevant
- Specific populations (pregnant women, immunocompromised)
- Example: "For use in adult patients (18 years and older)"

3. Body part or tissue:
- Anatomical location where device is used
- Type of tissue or organ involved
- Example: "Applied to intact skin" or "Implanted in the femoral artery"

4. Clinical effect or purpose:
- How the device achieves its intended medical purpose
- Mechanism of action (if not pharmacological, immunological, or metabolic for EU)
- Example: "By measuring blood glucose levels" or "By providing structural support to damaged tissue"

5. Use environment:
- Professional use (healthcare facility) vs. lay user (home use)
- Point-of-care vs. laboratory use
- Example: "For use by healthcare professionals in clinical settings" or "For self-testing at home"

6. Duration of use:
- Transient (<60 minutes), short-term (60 min - 30 days), long-term (>30 days)
- Relevant for invasive devices under EU MDR classification rules
- Example: "For temporary use during surgical procedures" or "Intended for permanent implantation"

Intended use vs. indications for use:

Intended Use (Global, including EU):
- Broader term encompassing overall purpose
- Used in EU MDR and internationally
- Can include non-specific descriptions
- Example: "A surgical scalpel intended for cutting soft tissue during surgical procedures"

Indications for Use (FDA-specific):
- More specific description used by FDA
- Focuses on disease/condition and patient population
- Required format for FDA submissions
- Example: "The ABC Device is indicated for the relief of symptoms associated with osteoarthritis of the knee in adult patients who have failed conservative treatment"

See related term "Indications for Use" for FDA-specific requirements.

Writing an intended use statement:

Best practices:
- Be clear, specific, and concise
- Focus on medical purpose, not features
- Avoid overly broad or vague statements
- Support with appropriate evidence
- Align with labeling and promotional materials
- Consider regulatory precedents for similar devices

Example - Good intended use statements:

"The XYZ Monitor is intended for continuous monitoring of heart rate, blood pressure, and oxygen saturation in adult patients in hospital critical care settings."

"The ABC Test is an in vitro diagnostic device intended for qualitative detection of SARS-CoV-2 antigens in nasal swab specimens from individuals suspected of COVID-19 by their healthcare provider."

"The DEF Implant is intended for lumbar spinal fusion in skeletally mature adults with degenerative disc disease at one or two contiguous levels from L1-S1."

Example - Problematic statements (too vague):

"Intended to improve patient health" - Too broad, no specific indication
"For use in hospitals" - Describes location, not medical purpose
"Advanced diagnostic system" - Describes technology, not clinical use

Impact on clinical evaluation and evidence:

Clinical evidence must support intended use:
- Clinical investigations designed around intended use claims
- Literature review focuses on same indication and population
- Post-market clinical follow-up monitors performance for intended use
- Any claims beyond demonstrated evidence can be considered off-label

Performance requirements derived from intended use:
- Specifications must enable device to fulfill intended use
- Testing protocols verify performance for stated purpose
- Risk analysis examines hazards related to intended use (and foreseeable misuse)

Regulatory authority review:
- Regulators assess if evidence supports intended use claims
- May request clarification or narrowing of overly broad intended use
- Can determine device is adulterated/misbranded if use not supported
- Post-market surveillance may reveal unapproved uses requiring action

Changes to intended use:

When intended use changes:
- Modifications expanding or changing medical indication
- Addition of new patient populations (e.g., pediatric extension)
- Change in body site or duration of use
- Alterations to clinical effect or mechanism

Regulatory implications:
- May require new regulatory submission (PMA supplement, new 510(k))
- Can change device classification, triggering different pathway
- Requires updated labeling, instructions for use
- May necessitate new clinical data or evaluation
- EU: May require Notified Body review and updated certificates

Off-label use:
- Use of device for purposes not included in approved/cleared intended use
- Not illegal for physicians to prescribe off-label in many jurisdictions
- Manufacturer cannot promote off-label uses
- Manufacturer may become aware through complaints or surveillance
- If significant, may prompt manufacturer to pursue regulatory approval for expanded use

Intended use in different regulatory frameworks:

EU MDR:
- Term: "Intended Purpose"
- Defined in Article 2(12): Information supplied by manufacturer on label, instructions, promotional materials
- Used in conjunction with manufacturer's claims
- Central to determining if product is medical device (Article 2(1))
- Basis for classification per Annex VIII rules

USA FDA:
- Term: "Intended Use"
- 21 CFR 801.4: Objective intent of manufacturer
- Determined by labeling claims, advertising, oral/written statements
- Inferred from circumstances surrounding distribution
- Central to 510(k) substantial equivalence determination

Canada Health Canada:
- Term: "Intended Use"
- Defined in Medical Device Regulations
- Basis for classification per Schedule to Regulations
- Must be clearly stated in device license application

Australia TGA:
- Term: "Intended Purpose"
- Aligns with Global Harmonization Task Force (GHTF) definition
- Critical for ARTG inclusion and classification
- Must be supported by conformity assessment evidence

Japan PMDA:
- Term: "Intended Use" (使用目的)
- Specified in approval/certification applications
- Determines regulatory category (pharmaceutical vs. medical device)
- Reviewed against clinical data in PMDA submissions

Common pitfalls:

Too broad:
- "For improving patient outcomes" - Not specific enough
- Harder to gather supporting evidence for wide claims
- May trigger higher classification than necessary

Too narrow:
- "Only for use in XYZ Hospital" - Unnecessarily restrictive
- Limits market and may not reflect actual capabilities
- May be difficult to justify such narrow scope

Inconsistency:
- Intended use in regulatory submission differs from labeling
- Marketing materials make claims beyond stated intended use
- Creates compliance risk and potential for misbranding

Unsupported claims:
- Intended use not backed by performance data or clinical evidence
- Regulators will question or reject submission
- Post-market enforcement actions possible

Failure to update:
- Intended use not revised when device design changes
- New uses emerge post-market but not incorporated
- Missed opportunities for label expansion

Strategic considerations:

Initial intended use:
- Balance between narrow (easier to support) and broad (larger market)
- Consider competitive landscape and predicate devices
- Align with clinical evidence readily available or feasible to generate
- Plan for potential future expansions

Lifecycle management:
- Monitor post-market use patterns and emerging applications
- Proactively pursue regulatory approval for common off-label uses
- Adapt intended use to evolving clinical practice and evidence
- Leverage real-world evidence to support expanded indications

Global harmonization:
- Use terminology and format accepted across jurisdictions
- Ensure intended use statement translates well into other languages
- Consider cultural and clinical practice differences in various markets
- Align with international standards (ISO, IEC) definitions

Intended use is the foundation of medical device regulation, shaping classification, evidence requirements, regulatory pathways, and post-market obligations. A well-crafted intended use statement, supported by robust evidence and consistently communicated, is essential for regulatory success and market access.