RegAI: Intended Purpose

Intended Purpose Statement Form for Medical Devices

When introducing a new medical device to the market or revising the scope of an existing one, it’s crucial to have a clear and precise intended purpose statement. This statement outlines the primary objective of the device, its target audience, mode of operation, and any limitations associated with its use. The statement helps regulatory authorities understand the classification, risk profile, and appropriate regulatory pathway for the product.

To streamline the process and ensure that all relevant details are included, we’ve designed a structured form. This form uses the following info to guide you in providing the necessary information:

  • DEVICE PRODUCT NAME: The official name or designation of your medical device.
  • MEDICAL CONDITION OR DISEASE: The specific medical condition or disease the device addresses.
  • TARGET POPULATION: The primary users or beneficiaries of the device.
  • FUNCTION ACTION: The core function or action the device performs.
  • BODY PART OR SYSTEM: The part of the body or bodily system the device interacts with or affects.
  • MODE OF INTERACTION: Describes how the device interacts with the body (e.g., invasive, non-invasive, implantable).
  • DURATION OF USE: Specifies how long the device can or should be used.
  • LIMITATIONS OR EXCLUSIONS: Any situations or conditions under which the device should not be used or any associated risks.

By filling out the form using these placeholders, you’ll be guided to craft a concise and clear intended purpose statement, essential for regulatory compliance and effective communication to healthcare professionals and patients. Please provide as much information as possible.

Remember to consult with your regulatory and clinical teams to ensure that the resulting statement meets your region’s specific requirements and reflects your device’s true capabilities and limitations.

Intended Purpose Form: