The Medical Device Amendments of 1976 regulates consumer access to new and improved devices, while keeping unsafe or ineffective ones off the market. Medical device compliance standards are overseen by the U.S. Food and Drug Administration, which conducts reviews through its Center for Devices and Radiological Health. Device manufacturing is complex, but modern quality management software tools can help navigate and streamline the process. Quality managers at any medical device manufacturing company are expected to adhere to current good manufacturing practices, or CGMPs. These were authorized in the Federal Food, Drug, and Cosmetic Act, a regulation that took effect in 1978. The CGMPs cover the methods, facilities, and controls used in the manufacture, package, storage, label, installation, and service processes. Read on for a primer on medical device compliance.
Medical device standards: classification, PMS and 501(k)
The following are important medical device compliance standards for manufacturers to consider:
Device Classification
The 1976 amendments separated pre-amendment devices into three categories. Each is subject to general controls, which include registration, device listing, pre-market notification, and requirements to follow good manufacturing practices. The three classes are:
- Class I: Safety and efficacy of the device is assured through general controls. Such devices carry a low risk of illness or injury to a patient, and are exempt from quality system regulation and pre-market notification requirements.
- Class II: Devices are considered moderate risk and are subject to special controls. These cover labeling, post-market surveillance, and mandatory performance standards
- Class III: There is insufficient information to assure safety through general or special controls support. Generally, the category covers life-sustaining or life-supporting devices.
Pre-Market Approval (PMA)
A PMA is based on FDA approval of the device per scientific evidence of its safety and effectiveness. Device descriptions and summaries of clinical and nonclinical data must be included, as should use indications and manufacturing process descriptions.
510(K) Notification
A 510(k) notification is required for any device considered to be of moderate risk. Changes in product design or new indications sought by manufacturers might trigger such notification. Traditional 510(k) submissions usually involve pre-clinical studies. Abbreviated and special 510(k)s arose from the Food and Drug Administration Modernization Act of 1997 to expedite FDA review of routine device submissions. Other standards apply to device labeling, post-marketing surveillance, inspection, and compliance. However, there are more recent changes that manufacturers must follow.
Changes to Medical Device Compliance Regulations
The Safe Medical Devices Act of 1990 revised the CGMP regulation to include design controls and ensure consistency with international standards. Introducing a framework, the regulation applied the same approach as the CGMP to give manufacturers flexibility based on the type of device they produced. Manufacturers are required to develop their own quality systems under the law. More recent changes:
FDA Amendments Act of 2007
Amended previous acts and added reporting and safety requirements for manufacturers that produce devices for children. It also added a requirement for public registration of clinical trials for medical devices and their results.
FDA Safety and Innovation Act of 2012
Aside from reauthorizing and creating new user fee programs, the legislation modified pre-market and post-market device regulation, including post-market surveillance and studies, device recall, and tracking.
How Quality Management Software Can Help Medical Device Compliance
Regulatory medical device compliance presents many challenges to medical device manufacturers. Quality management software can help manufacturers as it can prevent global nonconformance and its consequences. For example, Cority’s enterprise quality management software offers modules for mobile audits, risk management, and customer complaint management. It provides tools for automated change management to ensure alterations are effectively communicated. Anything less, and the manufacturer incurs the costs of poor product quality. Cority also features modules for managing documentation, inspections & SPC, and equipment maintenance, which make standard production and corrective actions more time and cost-effective. It covers process flow, supplier quality, and employee training & competency. Leveraging Cority, medical device manufacturers can adhere to all aspects of regulatory compliance and manage the components of their processes.
