Registering a medical device in the United States

In the US there is a body called FDA (Food & Drug Administration) who is responsible for managing the regulations and ensuring their implementation. Medical devices have to pass a series of checks depending on their type. These controls are usually the WFP and the 510(K).

  • FDA regulates medical devices, assessing its safety and effectiveness

  • FDA classifies devices by class, regulatory control, and application requirements

Device Regulations

  • Federal Code of Regulations 21 (cf): parts 800-1050

    • 800-861: Cross-sectoral device requirements

    • 862-1050: Specific device requirements

  • cf 21: parts 1-99

    • General medical requirements that also apply to medical devices

Device Classification

  • Based on the description and planned use of the device

  • Determines the scope of regulatory control

  • Class I, Ii, or III increases with the level of risk

  • Product codes: three letters to group devices with similar planned uses

  • Most Class I devices and some Class II devices are exempt from review if they are extremely low risk or very similar to existing devices. Anyway, these exempt devices must meet manufacturing and quality control standards.

  • Class II devices generally undergo a review 510(K), that focuses on determining whether the new device is "substantially equivalent" to an existing device. Reviews 510(K), usually, clinical trials are not required to demonstrate this substantial equivalence.

  • Manufacturers of Class III devices submit an application for pre-market approval (premarket approval, PMA). During the review of the application, FDA experts decide whether the new device is safe and effective for treating a specific disease or condition. The PMA process should include results from clinical studies, although the design of the specific study varies by device. For minor changes to existing Class III devices, WFP supplements are presented instead of a full WFP.

 

Quality System:
A Quality System is required according to the 21 CFR Part 820 et alters. whereas, compared to previous versions of the same standard, the requirements provided for by the latest version of the ISO 13485:2016 get closer to Regulating Quality Management Systems(QSR), the FDA has expressed its intention to harmonize QSR with international requirements, passing the QSR – 21 cf 820 to the ISO 13485:2016.


procedure:

In order to be marketed in the United States, all medical devices must be registered by the FDA. Production facilities undergo FDA inspections to ensure compliance with U.S. BPF requirements. In addition, all establishments where production operations are carried out, distribution, import and marketing of medical devices in the United States have to be reported and registered by the FDA, through establishment registration, in accordance with the 21 cf 807


applicant:

Foreign manufacturers who wish to market their medical devices in the United States must appoint a U.S.. Agent, i.e. a Local Representative responsible for communications with the FDA.


Steps to Follow to Introduce a New Product to the Market

  1. Establish the Product

    • Identify the product description (device)

    • Identify the purpose

    • Planned use (usually broad)

    • Indications of use (more specific)

    • Duration of use

    • population (age rank; illness)

  2. Check if your Product is a Medical Device

  3. Identify classification and regulatory course

    • Identify regulatory classification

    • The classification will usually indicate the regulatory course (type of pre-market application) your device requires

  4. Develop Valid Scientific Evidence
    • 21 cf 860.7(c)(1) – requires valid scientific evidence for safety and effectiveness

    • 21 cf 860.7(c)(2) – provides a valid definition of scientific evidence

  5. Prepare your Pre-Market Application

Each type has a number of

    • Processes

    • applicable laws and regulations

    • review time

    • cluster of evidence

Types of Pre-Market Applications

    • Investigative Device Waiver (ide)

    • Pre-market notification (510(K))

    • Pre-market Approval Application (PMA)

    • De Novo

    • Humanitarian Exemption from a Device (HDE)

Investigative Device Waiver (ide)

    • Clinical research on research devices

    • Collects safety and effectiveness data for future market requests

    • Requires approval Institutional Council Board

    • Protect human patients

Pre-market notification - 510(K)

    • The Market Request is for low- and moderate-risk devices

    • "Significant Equivalence" between a new device and a legally marketed device

 

Registering a medical device in the United States

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