Federal standards governing the safety and efficacy of medical products have been overseen in the United States by the FDA since the original 1906 Food and Drugs Act. The approach to medical product safety on the federal level has evolved over the years, but it was not until 1976 that the Medical Device Amendments were passed to ensure the safety and efficacy of medical devices. Today, many countries in addition to the U.S. have regulations governing the design, manufacturing, and sale of medical devices within their borders. Compliance with these regulations is mandatory, and non-compliance has far-reaching consequences, including fines, forced cessation of manufacture, import bans, and even criminal prosecution.
Because of the importance of regulatory compliance in the design and manufacture of medical devices, a wide array of standards and guidances has been developed by different governing and consulting bodies. Each standard is intended to meet the requirements of a particular regulation or group of regulations, or to provide further clarification on how a regulation is to be met. Because of the regulatory complexity of the international market for medical devices, certain standards are also intended to harmonize the regulations of different countries. Though the standards landscape can appear complex—there are at least 1,102 medical device standards recognized in the world today—a systematic approach to understanding which standards apply in a given setting is possible. This paper will focus on U.S. regulations, with mention given to a few of the standards outside of U.S. jurisdiction.
Multiple organizations have produced standards or guidances relevant to medical devices. It is helpful to understand the difference between these organizations in order to fully grasp the applicability of the standards produced by them. Some of the most important organizations include:
- International Medical Device Regulators Forum (IMDRF)—This is a voluntary group of medical device regulators from around the world whose goal is to promote international harmonization of medical device regulations among participating countries. These countries include Japan, the U.S., Russia, Canada, Australia, China, Brazil, and the EU. The IMDRF supersedes but builds on the similar work of the Global Harmonization Task Force (GHTF).
- International Standards Organization (ISO)—ISO has produced a number of standards (ISO 13485, ISO 14971, etc.) that are meant to guide medical device manufacturers towards regulatory compliance. Compliance with ISO standards is usually voluntary, as this organization has no official oversight of medical device manufacture in any country. However, many device manufacturers seek certification to an ISO standard, especially 13485, as an indication that they are compliant with regulatory standards and recognized best practices.
- International Electrotechnical Commission (IEC)—This organization prepares and publishes international standards for all electrical, electronic, and related devices, including medical devices. Each of its member countries has a vote in what goes into an IEC standard. Specific to medical devices, IEC standards include IEC 60601, IEC 62304, IEC 62366, IEC 80001, and others.
- United States Food and Drug Administration (FDA)—The FDA has legally-binding oversight of medical device design, approval, manufacture, and sale in the U.S. The specific branch of the FDA in charge of medical devices is the Center for Devices and Radiological Health (CDRH). Applicable medical device standards include CRF 21 Part 820, which is legally binding on device manufacturers, as well as numerous CDRH guidances which expound on what compliance with Part 820 means.
The FDA controls the medical device industry in the US through several processes: - Review and audit of a company’s quality management system
- Review and approval/rejection of new devices
- Control of labeling to ensure labeling matches intended use
- Monitoring and investigation of post-market device-related incidents
- It is important to note that Part 820 applies to all medical devices marketed in the United States, even if they are manufactured elsewhere. The FDA conducts inspections and issues citations of non-compliance to manufacturers outside the U.S. if their devices are exported to the U.S.
- Other international regulatory bodies—Each country is governed by its own set of medical device regulations. Of note, European Union countries have collaborated to produce a set of non-binding guidances that are meant to cover member-country regulations. These are named according to the convention Year/#/EEC. One such guidance is 92/42/EEC. Other IMDRF members recognize many standards in common, including IMDRF, GHTF, ISO, and IEC standards, but in the end each country regulates the medical device industry with its own regulations, so that Part 820 has no bearing on medical devices outside of the U.S., EEC guidances are irrelevant to a device sold only in the U.S., and so on.
Once you are familiar with the organizations that create and publish medical device standards, understanding which specific standards apply to a particular medical device manufacturer becomes easier. In the U.S., the best starting point is an understanding of CFR 21 Part 820.
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