What Is a Medical Device?
The FDA defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is 1) recognized in the official National Formulary, or the United States Pharmacopeia, or any, 2) supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or 3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes (21 U.S.C. 321(h)).” See Is the Product A Medical Device?
Device Regulations Overview
Clinical investigations of devices to determine safety and effectiveness must be conducted under an Investigational Device Exemption (IDE), meet the abbreviated requirement for an IDE, or be exempt from the IDE requirements. See 21 CFR 812, Frequently Asked Questions About Medical Devices and Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.
When device research is conducted under an IDE, the FDA will issue an IDE number. See IDE Approval Process. When device research is not conducted under an IDE, and the research does not meet the exempt from the IDE process requirements, the Board will determine if the device is of Significant Risk or Nonsignificant Risk. If the Board determines the device is of Significant Risk, an IDE must be obtained by the Sponsor. See Significant Risk and Nonsignificant Risk Medical Device Studies for a sample of device classifications
Who Is a Study Sponsor?
A Sponsor is a person who initiates a clinical investigation, but who does not actually conduct the investigation, i.e., the test article is administered or dispensed to or used involving, a subject under the immediate direction of another individual. A person other than an individual (e.g., corporation or agency) that uses one or more of its own employees to conduct a clinical investigation it has initiated is considered to be a sponsor (not a sponsor-investigator), and the employees are considered to be investigators.
A Sponsor-Investigator is an individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject. The term does not include any person other than an individual, e.g., corporation or agency. See 21 CFR 812.3 Definitions and The Sponsor: Responsibilities in Medical Device Clinical Trials.
Human Subject Protection and Device Research
Investigators are responsible for ensuring the clinical trial is conducted according to the study protocol, the investigator’s agreement with the study sponsor and applicable regulations. The investigator is also responsible for protecting the rights, safety and welfare of study participants at the investigator’s site and for the control of the device under investigation. For device research involving human subjects, the study sponsor or investigator must engage an IRB to review and approve the study and to oversee human subject protections throughout the life of the study. Investigators must ensure that the requirements for obtaining informed consent are met. See Protecting the Rights, Safety and Welfare of Study Subjects – Supervisory Responsibilities of Investigators.
Premarket Notification (PMN or 510k)
The Food, Drug and Cosmetic Act in section 510(k) requires registration of devices that are intended for market to demonstrate that the device to be marketed is at least as safe and effective (i.e., substantially equivalent) to a legally marketed device. This is known as a Premarket Notification (PMN) or 510[k]). The FDA will determine if the device is substantially equivalent to a device already approved. See 510(k) Clearances Overview and 510(k) Premarket Notification Database. See also Class I Device Exemptions, Class II Device Exemptions and Required Submission of Safety and Effectiveness Information for Certain Class III Devices.
Premarket Approval (PMA)
Class III medical devices are those devices that are used to support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. For these devices, the FDA has developed a premarket approval (PMA) review process which includes a scientific and regulatory review to evaluate the safety and effectiveness of these devices. The PMA holder must receive PMA approval prior to marketing the device. See Premarket Approval (PMA) Overview and Premarket Approval (PMA) Database.
In Vitro Diagnostic Devices
In vitro diagnostic products are medical devices such as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its after effects. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body (21 CFR 809.39(a)). See In Vitro Diagnostic (IVD) Device Studies-Frequently Asked Questions and Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable.
Humanitarian Use Device (HUD)/Humanitarian Device Exemption (HDE)
Some medical devices can be classified as a Humanitarian Use Device (HUD) which allows greater access to the device for patients with rare diseases and conditions. FDA defines HUD as a “medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.” See Humanitarian Device Exemption (HDE) Regulation: Questions and Answers (please note a draft update to this guidance was also posted in March 2014, see Draft FDA Guidance).