Glossary for Regulatory Knowledge Guide
Glossary of Regulatory Terminology
510(k) Pre-Market Notification: The most common market application. The innovator proves their device is substantially equivalent to an existing device. If successful, the FDA will “clear” the device. Typically applicable for Class II (medium risk) devices.
510(k) Summary: A required overview of the similarities and differences between the subject device and its predicate. The summary includes an Indications For Use statement, and a brief summary of the testing that was carried out as part of the 510(k) application. These are publicly accessible for all 510(k)-cleared medical devices.
AI, Artificial Intelligence: the simulation of human process and decision making by computer systems
Benefit-Risk Ratio: the ratio of potential benefits and harms of a medical product. Benefits include the device’s impact on patient health and safety - how much the device can aid in improving patient function, preventing loss of function, or providing relief. Risks range from malfunctions that cause no harm, to serious events that could cause injury or death. In evaluating risks, the innovator should identify all of them - and take into account the severity and likelihood of each. Products with more risk should have more benefit (to maintain or improve the “Ratio”).
CE Mark: symbol of conformity with health, safety and environmental protection standards for products sold within the European Economic Area (Conformité Européenne).
Clinical Trial: voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of therapies, or new ways of using existing treatments.
CGMP, current good manufacturing practices: a quality system for FDA-regulated products to ensure product consistency and that applicable agency guidelines are met.
De Novo: A Market Authorization application for first-of-their-kind devices, whose risk level does not require a PMA. The innovator proves that their device is safe, and that future similar devices can safely utilize 510k. If successful, the FDA will “grant” the De Novo request for classification. Applicable for new devices that can be developed using methods suitable for Class II (medium risk) devices.
Design controls: a formal and documented methodology for product development activities.
FDA Pre-Market Application: materials submitted to FDA so that they can evaluate the safety and efficacy of a device before it is allowed to be sold.
Final finished form (FFF): term used for a device or device component that includes all manufacturing processes for the to-be-marketed device including packaging and sterilization, if applicable. Refers primarily to the physical configuration and materials of the device.
GLP, Good Laboratory Practices: A quality system for non-clinical health and environmental safety studies intended to establish processes and conditions under which an organization should plan, perform, monitor, record, archive, and report such studies.
IDE, Investigational Device Exemption: an FDA determination that allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data.
IFU, Indications for Use: The conditions or reasons or situations or contexts for someone to use the device. For example, the IFU of an MRI scanner could be “Images are derived from nuclear magnetic resonance properties. Additional contrast agents may be used. When interpreted by a trained physician, can yield information to aid in diagnosis.”
Intended Use: The general purpose of the device: what the device is meant to do. For example, the Intended Use of an MRI scanner is “make images of internal structures of the body”. It is worth noting that for the 510(k) pathway, the device and its predicate must have the exact same Intended Use.
IRB, Institutional Review Board: an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities.
ISO, International Organization for Standardization: an international organization which develops, documents, and updates standards for quality management systems, as well as a wide variety of specific technologies and processes.
ML, Machine Learning: An application of AI that provides systems the ability to learn and improve from data without being explicitly programmed. Generally, the “learning” can be supervised, semi-supervised, or unsupervised, which describes the amount of human involvement in updates to the system. Deep learning is a type of machine learning that is even more data driven; it is based on an extensive mathematical framework called an artificial neural network.
PMA, Pre-Market Approval: The most expensive (time/money/complexity) market application. The innovator proves their device is safe and effective. If successful, the FDA will “approve” the device. Typically applicable for Class III (high risk) devices.
Predicate device: when submitting a 510k application, all innovators must identify an existing device that is substantially equivalent (similar in technical characteristics, and identical in Intended Use) to the technology they have created. That existing device is called a predicate.
Pre-IDE Meeting: a type of pre-submission meeting between the innovators and FDA, for discussion of a significant-risk study protocol. These meetings help to clarify what FDA expects to review in an IDE submission (including clinical and pre-clinical data), that can streamline the IDE and clinical trial allowance process.
Pre-Submission Meeting, aka pre-sub, aka Q-sub: An opportunity for an innovator to obtain FDA feedback prior to an intended premarket submission. The meeting request should include specific questions regarding relevant review issues. Innovators are not limited to a single pre-submission meeting. Each pre-submission meeting should have one primary area of focus to help the innovator progress their device to its next value inflection point.
Product code: Product codes are created within each regulation to for convenience of keeping track of various sub-types of devices within the regulation. These abbreviations look like “NPL”. From the product classification database, one can find existing product codes by keyword, regulation, or other info. There are often multiple product codes within one regulation.
Prototype: a first, preliminary version of the device, from which other forms are developed or copied.
Regulations: Medical device regulations are established by FDA to classify the device based on type and description, as well as create the applicable review pathway for all future similar devices. Device regulation numbers look like “21 CFR 872.3930”. From that link you will find a description of a specific type of device (in this example, bone grafting material). You will also find its classification (pre-identified level of risk).
RWE, Real-World Evidence: the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data.
RWD, Real-World Data: the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources (health records, registries, patient-generated data, or data gathered from other sources).
Significant Risk (SR) and Non-Significant Risk (NSR) Device/Study: two designations for IRB/FDA authorized human studies. Per FDA, a SR device is an investigational device that: (1) is intended as an implant; (2) is for use in supporting or sustaining human life; (3) is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health; and/or (4) otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. NSR devices are those that do not meet any of these criteria.
Standards: Something established by authority, custom, as an acceptable model, example, or point of reference. Here often a test method, or test criteria.
Quality Management System, QMS: a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. Device manufacturers are required by law to have a QMS, and it will be inspected by FDA periodically.
Validation: As in software verification and validation (V&V). Validation is establishing that the software conforms with user needs and Intended Uses of the device. It is part of checking the quality of the finished device design. Validation is a holistic check on the use of the software system.
Verification: As in software verification and validation (V&V). Verification is establishing that the requirements have been fulfilled. Examples include software module and integration testing, or code walkthroughs and inspections. Verification is a specific check on a technical feature/component.
