Devices in various industries must follow device compliance policies, and manufacturers must provide documentation to prove their adherence to these regulations. Understanding what device compliance is and how to record it helps companies improve their products’ quality and safety.
What Is Device Compliance?
Device compliance refers to the state of devices meeting the standards and regulations for the industry. Achieving device compliance is beneficial for:
- Manufacturers: Manufacturers can promote the development and production of quality devices while reducing costs and increasing profits.
- Customers: Customers will be satisfied with the integrity of the product and the competitiveness in the market.
- Organizations: Organizations that use these products — such as a drug manufacturer or hospital — can be confident they will perform as intended.
Different policies exist across industries for device compliance with the American Society for Testing and Materials (ASTM) and the Food and Drug Administration (FDA). Companies must adopt these standards for safety and efficacy.
FDA Device Compliance
The Food and Drug Administration (FDA) protects public health by regulating device compliance and conducting other tasks. This entity has many standards and regulations for various industries. For example, it regulates many medical devices such as pacemakers, prosthetics and surgical implants. The FDA also has standards for the equipment in food and dietary supplement processing. Failure to adhere to FDA standards may result in an inspection citation and actions from the FDA to enforce these laws.
Device Compliance Standards for ASTM
The American Society for Testing and Materials (ASTM) is an organization that develops and publishes technical standards to make procedures safer for various industries. ASTM standards are in place for many systems, products, services and materials. ASTM does not enforce its standards. Companies can adopt the standards that apply to their industry, require ASTM compliance for particular contracts or generate material data sheets that outline ASTM requirements.
