The term “medical device”, as defined by the U.S. Food and Drug Administration (FDA) covers a broad spectrum of objects. Tongue depressors, gauze pads, and surgical masks all qualify as medical devices, as do blood chemistry analysis kits, electronic health monitoring devices, medical imaging equipment, and implantable devices such as pacemakers and artificial joints.
But how can you be certain that the infrared thermometer you just bought at the pharmacy is any good? One word: Standards. Various national and international device standards for safety, efficacy, and quality govern the design, development, and manufacture of medical devices.
Medical device manufacturing companies must adhere to these standards in order to market and sell their products. In this article, we review some of the important standards for medical devices.
The relevant medical device standards are divided into two broad areas:
- Quality management
- Safety and efficacy
It’s impractical for any medical device regulatory or standards body to inspect every device and evaluate its quality. Instead, they evaluate the effectiveness of each manufacturer’s quality management system. In the U.S., quality management systems for medical devices are regulated by Title 21, Part 820 of the Code of Federal Regulations (abbreviated as 21 CFR 820), as published in the Federal Register.
This set of regulations covers a wide range of quality-related practices for medical device manufacturers. A manufacturer must be able to show that they have, among other things:
- A standard device design process that documents all design inputs, outputs, reviews, and approvals
- A change control process for modifying product designs, quality assurance processes, and manufacturing processes
- A risk management process for objective evaluation and mitigation of risk
- A system for documenting, tracking, and resolving customer complaints
- A process for implementing corrective and preventative actions (CAPAs)
- Supply-chain traceability for all product components and testing and manufacturing equipment
- Verification and validation processes that document the testing of new products against their requirements and intended use
- A training management process to show that employees have been trained on the processes they perform
In the European Union (EU) and other countries, medical device manufacturers are required to achieve certification in International Standards Organization (ISO) standard 13485. Similar to ISO 9001, which defines general quality standards, ISO 13485 defines specific standards for the medical device industry.
The ISO 13485 requirements are substantially similar to those of 21 CFR 820, and incorporate the risk management requirements of ISO 14971.
ISO 13485 certification is performed by independent certification providers who evaluate each manufacturer by means of an annual audit of the company’s quality records. FDA inspectors perform similar audits, although the frequency can vary.
Safety and Efficacy
The Food, Drug, and Cosmetic Act of 1938 and the 1976 medical device amendments require manufacturers to show that their medical device products are safe and effective for their intended uses in order to sell them in the U.S.
The FDA classifies medical devices according to their risk levels. Class I devices are simple, low-risk devices such as adhesive bandages. Class II devices, such as diagnostic testing kits, are considered medium risk, whereas Class III devices are devices designated as having the highest potential for risk.
Class II and III devices must go through one of two evaluation and approval processes:
- Premarket Authorization (PMA), a stringent process of clinical trials for Class III devices and those Class II devices that are unlike other devices on the market
- Premarket Notification (PMN), a less-demanding process for Class II devices that are substantially the same as other devices on the market (note that some Class I devices also require PMN, while some Class II devices are exempt)
A PMA can take years to complete and cost a company millions of dollars to conduct the required clinical trials and provide all the required documentation. By contrast, the PMN (also known as a “510(k)” in the medical device industry) costs much less and involves less-extensive clinical evaluation.
In either case, an application and supporting documentation must be submitted to the FDA for evaluation. Approved devices can then be marketed in the U.S. Similar evaluation and approval processes exist in other countries, and manufacturers must meet those national standards to sell their products in those countries.
Bottom Line: Patient Safety
Most patients–indeed, many physicians–lack the expertise and resources required to evaluate the safety, efficacy, and quality of medical devices. Thus, it became necessary to develop standards for device manufacturers to meet, as well as processes for evaluating their compliance.
The resulting medical devices guidance, regulations, recognized consensus standards, and other guidance documents are intended to assure patients and their doctors that a given medical device will do what it’s designed to do and is free from major design errors.
But this regulatory environment can be complex. RBC Medical Innovations specializes in helping medical device companies navigate this environment and bring your products to market faster and with fewer hiccups. Contact us today to learn how we can help you with your challenges in medical device manufacturing.