30 Medical Device Acronyms You Should Know

Navigating the medical device industry involves understanding a plethora of acronyms and specialized terms. Here’s a comprehensive guide to 30 key acronyms and terms that are crucial for professionals in this field. Each entry includes a brief explanation to help you grasp their importance and application.

1. 21 CFR Part 820

The section of the Code of Federal Regulations that sets forth the Quality System Regulation (QSR) for medical device manufacturers. It establishes requirements for a comprehensive quality system to ensure products consistently meet applicable requirements and specifications. Adhering to these regulations helps manufacturers minimize risks and ensure device safety and effectiveness.

2. 483

Form 483 is issued by the FDA to document and communicate concerns discovered during inspections. These observations point out conditions that may violate the Food, Drug, and Cosmetic Act or other related regulations. Companies receiving a Form 483 must respond with corrective actions to address the cited issues.

3. 510(k)

A premarket submission made to the FDA to demonstrate that a medical device is at least as safe and effective as a legally marketed device. A 510(k) is required for devices that do not require premarket approval but still need clearance before being marketed. The process involves comparing the new device to a predicate device already on the market.

4. ASL (Approved Supplier List)

A list of suppliers that have been evaluated and approved by a company for providing specific materials, components, or services. Maintaining an ASL helps ensure that incoming products meet quality and regulatory requirements. It also facilitates better supplier management and consistency in the supply chain.

5. CA (Competent Authority)

National regulatory bodies in the EU responsible for ensuring that medical devices comply with regulations. They oversee the approval and monitoring of devices within their jurisdiction. Competent Authorities play a crucial role in safeguarding public health by enforcing compliance and conducting inspections.

6. CAPA (Corrective and Preventive Action)

A system used to investigate and address the root causes of non-conformities or undesirable situations. CAPA ensures that problems are corrected and prevented from recurring, enhancing product quality and compliance. It involves identifying the issue, determining the root cause, implementing corrective actions, and verifying their effectiveness.

7. CGMP (Current Good Manufacturing Practice)

Regulations enforced by the FDA that provide guidelines for manufacturing, testing, and quality assurance to ensure that products are safe and effective. CGMPs cover various aspects of production, from raw material handling to finished product distribution. Compliance with CGMPs helps prevent contamination, mix-ups, and errors.

8. De Novo

A regulatory pathway for medical devices that are novel and do not have a predicate device for comparison. It provides a classification process for low to moderate risk devices that have no existing classification. The De Novo process allows for innovative devices to enter the market with appropriate controls.

9. Design Controls

A systematic process applied to the design and development of medical devices. It ensures that all requirements are met and that the final product is safe and effective for its intended use. Design controls include planning, input requirements, design verification, validation, and changes.

10. DFM (Design for Manufacturability)

A process that ensures a product is designed in a way that makes it easy and cost-effective to manufacture. It aims to simplify product design, reduce costs, and improve quality and reliability. DFM involves collaboration between design and manufacturing teams to optimize the production process.

11. DHF (Design History File)

A compilation of records that describe the design history of a finished device. It demonstrates that the design was developed following the approved design plan and regulatory requirements. The DHF includes design inputs, outputs, verification, validation, and design review documentation.

12. DHR (Device History Record)

Contains the production history of a device, including dates of manufacture, quantity manufactured, quantity released for distribution, and any acceptance records. It ensures that each device batch meets specified requirements. The DHR provides traceability and evidence of compliance with manufacturing standards.

13. DMR (Device Master Record)

A comprehensive document that contains all the information necessary to produce a medical device. It includes design specifications, quality assurance procedures, packaging, and labeling specifications. The DMR serves as a reference for manufacturing and quality control.

14. MDD (EU Medical Device Directive)

The previous set of regulations governing the safety and performance of medical devices in the EU. It has been replaced by the Medical Device Regulation (MDR). The MDD established essential requirements for devices to be marketed in the EU.

15. MDR (EU Medical Device Regulation)

The current regulation that governs the production and distribution of medical devices in the EU. It aims to improve the safety and effectiveness of medical devices and includes more stringent requirements than the MDD. The MDR emphasizes post-market surveillance, clinical evaluation, and transparency.

16. FMEA (Failure Modes and Effects Analysis)

A systematic method for evaluating potential failure modes within a process and their effects on outcomes. It helps identify critical areas that need improvement to enhance product reliability. FMEA involves assessing the severity, occurrence, and detection of potential failures.

17. FTO (Freedom to Operate)

A legal assessment that evaluates whether a product can be marketed without infringing on existing patents. It helps companies avoid legal issues and potential litigation. Conducting an FTO analysis is crucial for protecting intellectual property and ensuring market access.

18. IDE (Investigational Device Exemption)

Allows a medical device to be used in a clinical study to collect safety and effectiveness data required for a premarket approval (PMA) application. It is critical for the development and approval of new medical devices. An IDE must be obtained before beginning clinical trials in the United States.

19. IFU (Instructions for Use)

Documentation provided by the manufacturer that explains how to use a medical device safely and effectively. It includes information on installation, operation, maintenance, and troubleshooting. Proper IFU ensures users can operate the device correctly and minimize risks.

20. IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification)

Three stages of validation for equipment and processes. IQ verifies proper installation, OQ confirms operational functionality, and PQ ensures consistent performance under real-world conditions. These qualifications are critical for ensuring equipment meets regulatory and operational standards.

21. IRB (Institutional Review Board)

A committee that reviews and approves research involving human subjects to ensure ethical standards are met. IRBs protect the rights and welfare of participants in clinical trials. They review study protocols, informed consent forms, and monitoring procedures.

22. IVD (In Vitro Diagnostic)

Medical devices used to perform tests on samples taken from the human body, such as blood or tissue, to diagnose diseases or conditions. IVDs are crucial for disease detection and monitoring. They must meet specific regulatory requirements to ensure accuracy and reliability.

23. MAUDE (Manufacturer and User Facility Device Experience)

An FDA database that collects reports of adverse events involving medical devices. It helps monitor device performance and identify potential safety issues. The MAUDE database is a valuable resource for post-market surveillance and trend analysis.

24. MDR (Medical Device Reporting)

A system used by the FDA to collect information about adverse events and malfunctions associated with medical devices. It helps ensure that devices remain safe and effective throughout their lifecycle. Manufacturers, importers, and device user facilities are required to report adverse events.

25. PMA (Premarket Approval)

The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. PMA is the most stringent type of device marketing application required by the FDA. It involves extensive clinical testing and documentation.

26. QMS (Quality Management System)

A structured system of procedures and processes covering all aspects of manufacturing, including quality control and assurance, to ensure products meet regulatory and customer requirements. A robust QMS helps organizations achieve compliance, improve efficiency, and enhance product quality.

27. SAMD (Software as a Medical Device)

Software intended to be used for medical purposes that perform these purposes without being part of a hardware medical device. SAMD includes applications for diagnostics, monitoring, and treatment. Regulatory requirements for SAMD focus on software validation and cybersecurity.

28. SOP (Standard Operating Procedure)

Detailed, written instructions to achieve uniformity in the performance of a specific function. SOPs are essential for maintaining quality and compliance in manufacturing and operational processes. They provide clear guidance to employees and ensure consistent execution.

29. UDI (Unique Device Identification)

A system used to mark and identify medical devices through their distribution and use. It helps improve patient safety by enabling more accurate reporting, reviewing, and analyzing of adverse event reports. The UDI system facilitates device traceability and recall management.

30. VAI (Voluntary Action Indicated)

An FDA inspection classification indicating that, while objectionable conditions were found, the agency does not deem regulatory actions necessary. It suggests that the company should voluntarily take corrective actions to address the issues identified. This classification is less severe than Official Action Indicated (OAI) but still highlights areas needing improvement to ensure compliance with regulations.

Understanding these acronyms and terms is essential for anyone working in the medical device industry. They provide a foundation for ensuring compliance, enhancing product quality, and safeguarding patient safety. By familiarizing yourself with these key concepts, you can navigate the regulatory landscape more effectively and contribute to the development of safe, reliable medical devices.