GLOSSARY

Medical Device Regulations

Definition

In the United States, the FDA establishes medical device regulations for medical device companies that wish to sell and market their products, including those for medical device quality management.

When a medical device manufacturer creates a medical device, it must be approved for sale by the FDA before it can be marketed or sold in the United States. The FDA establishes medical device regulations to ensure that medical devices available in the United States are both safe and effective for the end user. These regulations are a critical aspect of patient and consumer safety, but they can also benefit medical device companies. The FDA quality system requirements (QSR), for example, help manufacturers ensure that they built a device that consumers will want to purchase and that can therefore succeed in the marketplace.

What Medical Device Regulations Exist in the United States?

If your medical device company is developing a new product to be sold in the United States, you must be aware of the most important regulations established by the FDA. These regulations are published in Chapter 21 of the Code of Federal Regulations (CFR) and can be viewed in their entirety on the FDA website.

21 CFR Part 820 - FDA Quality System Regulations

Medical device companies who wish to market their products in the United States must be fully aware of and in compliance with the FDA Quality System Requirements found in 21 CFR Part 820, which sets forth the full requirements for medical device quality systems. In Part 820, the FDA provides guidelines for manufacturers to establish and maintain documented processes that control product design and development, product realization, corrective and preventive actions (CAPA), risk management activities, supplier controls and more.

The FDA conducts compliance audits of medical device companies, reviewing their policies and procedures, as well as technical documentation to ensure that the implemented quality system is effective and that the medical device regulations are being followed.

21 CFR Part 11 - Electronic Records; Electronic Signatures

In the past, medical device companies used rooms full of filing cabinets to manage quality documentation (many still do to this day). In today's digital age, an increasing number of medical device companies have adopted electronic quality management systems (eQMS) with automated, built-in document control and management features. In 21 CFR Part 11, the FDA supports this transition by establishing regulations for medical device companies that choose to manage and approve quality records in an electronic format.

The purpose of 21 CFR Part 11 is to establish equivalency between paper-based quality systems and electronic record systems, in order to ensure that medical device companies can guarantee the authenticity and security of quality data.

21 CFR Part 803 - FDA Medical Device Reporting

In addition to the medical device regulations for quality management, the FDA has created a mandate for reporting on medical device adverse events or malfunctions. Under 21 CFR Part 803, medical device manufacturers, importers and device user facilities are legally required to report to the FDA when they become aware of any adverse event involving a medical device that they brought to market. Medical device reporting regulations ensure that manufacturers are performing adequate follow-up measures when adverse events occur. The reporting regulations also allow the FDA to issue warnings to the public about potentially dangerous devices.

Greenlight Guru Supports Compliance with Medical Device Regulations

Greenlight Guru's eQMS Software has been purpose-built for 1-to-1 compliance with the electronic record-keeping requirements of 21 CFR Part 11 and the quality system regulations set forth in 21 CFR Part 820. Medical device companies that choose Greenlight Guru benefit from using a quality management software platform that provides full compliance with medical device regulations.

With enhanced visibility and control over all processes, integrated design controls and risk management and built-in workflows for managing CAPAs, complaints and nonconformance events, Greenlight Guru helps medical device companies ensure audit readiness and reduce time to market. Greenlight Guru lifts the regulatory burden from manufacturers so they can dedicate their time and resources toward building true quality into their medical device processes.