由 home-healthhaven 
Medical devices can have a huge impact on public health and wellbeing. But how does a single great idea transform into a marketed device? This brief overview explains the basics of medical device clinical trials, known as IDE (Investigational Device Exemption), which is a key pathway for getting a medical device to the US market.
**What is a Medical Device?**
The Federal Food, Drug, and Cosmetic Act defines a medical device as a product intended for diagnosing, curing, mitigating, treating, or preventing disease without relying on chemical interactions or being metabolized. The development process of a medical device starts with its concept and design, focusing on mechanical, physical, and performance specifications.
Imagine an architect drafting different designs of a building before finalizing the blueprints. Similarly, developing a medical device involves creating multiple prototypes in a lab setting using the right tools and equipment. This process follows traditional quality engineering development models, ensuring the device meets all necessary requirements before human use. Devices using new materials or groundbreaking technology might need extra testing for biocompatibility. It’s important to follow the standards on the FDA website when planning a device.
Before testing a medical device on people, the risk level of its use in a study must be assessed. The sponsor, who initiates the study, is responsible for categorizing the study into one of three types: Significant Risk (SR), Non-Significant Risk (NSR), or Exempt.
– An SR device poses a serious risk to the health or safety of a subject and must follow all IDE regulations in 21 CFR Part 812.
– An NSR device only needs to comply with the abbreviated requirements in 21 CFR 812.2(b).
– Devices with the lowest risk level are exempt from 21 CFR Part 812.
An Institutional Review Board (IRB) ethically oversees clinical trials to ensure FDA regulation compliance and subject protection. The sponsor must present the initial risk determination to the IRB, which can alter it if necessary. The FDA assists with risk determinations, conducts ongoing reviews, and both the IRB and FDA must approve SR studies before enrolling subjects.
The FDA works closely with sponsors during device development, offering meetings to discuss study designs, safety, effectiveness, and timelines at no cost. These interactions help sponsors understand FDA requirements, foster familiarity with new technologies, and streamline the process to avoid delays.
Sponsors need to choose appropriate investigator sites that can perform procedures, conduct FDA-regulated research, and have access to eligible subjects. Training clinical site staff before subject enrollment is crucial to ensure everyone understands their responsibilities.
Physicians and clinical investigators have different roles. Physicians focus on patient care, while clinical investigators aim to protect human subjects and adhere to study protocols, which helps advance future medical care. Before enrolling subjects, eligibility criteria must be met, and subjects must sign an IRB-approved consent form detailing risks, benefits, and other key information.
Monitoring a study, as required by 21 CFR Part 812, involves sponsors tracking data collection and ensuring protocol adherence. Any errors must be promptly corrected. Upon study completion, sponsors need to:
1. Ensure all follow-ups are done.
2. Submit a final report to the FDA.
3. Maintain all documentation for future inspections.
After gathering and analyzing all data, if safety and effectiveness points meet required standards, the sponsor can begin preparing their marketing application. They’ll discuss submission details with the FDA, expecting inspections at manufacturing or research sites.
In summary, turning a great idea into an IDE involves a thorough process engaging the FDA early on. This process ensures public health protection and promotes medical innovation.