FDA Requirements for New Medical Devices

medical device is defined, in part, as any health care product that does not achieve its primary intended purposes by chemical action or by being metabolized. Medical devices include, among other things, surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins. Medical devices also include diagnostic aids such as reagents and test kits for in vitro diagnosis (IVD) of disease and other medical conditions such as pregnancy. Investigators interested in studying a new medical device are required to address additional information in KRP when completing the IRB application or when requesting an amendment to an IRB-approved study.

  • Except for certain low risk devices, each manufacturer who wishes to introduce a new medical device to the market must submit a pre-market notification to FDA.
  • FDA reviews these notifications to determine if the new device is "substantially equivalent" to a device that was marketed prior to passage of the Medical Device Amendments of 1976 and the Safe Medical Devices Act of 1990 (i.e., a "pre-amendments device").
  • If the new device is deemed substantially equivalent to a pre-amendments device, it may be marketed immediately and is regulated in the same regulatory class as the pre-amendments device to which it is equivalent.
  • The pre-market notification requirement for new devices and devices that are significant modifications of already marketed devices is set forth in section 510(k) of the Act.
  • Devices determined by FDA to be substantially equivalent are often referred to as "510(k) devices."
  • If the new device is deemed not to be substantially equivalent to a pre-amendments device, it must undergo clinical testing and pre-market approval before it can be marketed unless it is reclassified into a lower regulatory class.

An investigational device is a medical device which is the subject of a clinical study designed to evaluate the effectiveness and/or safety of the device.

  • Clinical investigations undertaken to develop safety and effectiveness data for medical devices must be conducted according to the requirements of the FDA IDE regulations.
  • An approved IDE permits a device that otherwise would be required to comply with a performance standard or to have pre-market approval to be shipped lawfully for the purpose of conducting investigations of that device.
  • An IDE study may not necessarily commence 30 days after an IDE submission to FDA.
  • Certain clinical investigations of devices (e.g., certain studies of lawfully marketed devices) may be exempt from FDA IDE regulations.
  • The exemption applies only to investigations in which "510(k)'d" products are being used in accordance with the labeling cleared by FDA.
  • Investigation of an off-label use of a 510(k) product takes it outside this exemption.

Non-significant Risk and Significant Device Classification

Unless exempt from IDE regulations, an investigational device must be categorized as either "significant risk" (SR) or "non-significant risk" (NSR).

Risk Device Studies

If the sponsor considers that a study is NSR, the UCI investigator must ask the sponsor to provide the IRB with an explanation of its determination and any other information that may assist the IRB in evaluating the risk of the study. The sponsor should provide the IRB with:

  • a description of the device,
  • reports of prior investigations with the device,
  • the proposed investigational plan,
  • a description of patient selection criteria and monitoring procedures, as well as
  • any other information that the IRB deems necessary to make its decision.

The sponsor also should inform the UCI IRB whether other IRBs have reviewed the proposed study and what determination was made. The sponsor must inform the IRB of the FDA's assessment of the device's risk if such an assessment has been made. The IRB may also consult with the FDA for its opinion.

NSR studies do not require submission of an IDE application to the FDA. Instead, the sponsor is required to conduct the study in accordance with the "abbreviated requirements" of the FDA IDE regulations. Unless otherwise notified by the FDA, an NSR study is considered to have an approved IDE if the sponsor fulfills the abbreviated requirements.

Risk Device Studies

SR device studies must be conducted in accordance with the full IDE requirements of the FDA and may not commence until 30 days following the sponsor's submission of an IDE application to the FDA.

  • All SR risk studies require IRB full committee review.
  • The IRB's risk determination is based on the proposed use of a device in an investigation, and not on the device alone. In deciding if a study poses an SR, the IRB must consider the nature of the harm that may result from use of the device.
  • If the UCI IRB believes that a device study is SR, the investigation may not begin until both the IRB and FDA approve the investigation.
  • Documentation of the FDA IDE number must be submitted to the IRB before UCI IRB approval will be granted.
  • Researchers should be aware of the following requirement, per IDE regulations 21 CFR 812 §812.150:
    • Reports: “Significant risk device determinations. If an IRB determines that a device is a significant risk device, and the sponsor had proposed that the IRB consider the device not to be a significant risk device, the sponsor shall submit to FDA a report of the IRB's determination within 5 working days after the sponsor first learns of the IRB's determination.

Abbreviated FDA requirements for NSR Devices

Below is a summary of the FDA abbreviated requirements [21 CFR 812.2(b)] for NSR device studies:

  • Sponsor and local investigator agree to provide the UCI IRB with a brief explanation of why the device is not a significant risk device, and to obtain and maintain UCI IRB approval;
  • Sponsor labels the device in accordance with FDA requirements;
  • Sponsor and local investigator ensure informed consent is obtained from each subject, unless documentation is waived by the IRB;
  • Sponsor and local investigator comply with the FDA requirements for monitoring investigations, maintaining records and filing reports; and
  • Sponsor complies with FDA regulations pertaining to the prohibition of promotion and other practices of the device.
  • The investigation does not involve a device that was approved under an IND (on or before July 16, 1980).

FDA Definitions for Device Studies

The following definitions will assist investigators with the significant risk and non-significant risk classification:

Noninvasive when applied to a diagnostic device or procedure, means one that does not by design or intention:

  • Penetrate or pierce the skin or mucous membranes of the body, the ocular cavity, or the urethra, or
  • enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the pharynx, the anal canal beyond the rectum, or the vagina beyond the cervical os.
  • Blood sampling that involves simple venipuncture is considered noninvasive, and the use of surplus samples of body fluids or tissues that are left over from samples taken for non-investigational purposes is also considered noninvasive.

Significant risk device means an investigational device that:

  • Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
  • Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;
  • Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
  • Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

Implant means a device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. FDA may, in order to protect public health, determine that devices placed in subjects for shorter periods are also "implants."

SR and NSR Examples

Below are several examples of SR and NSR devices.

Note: Inclusion of a device in the NSR category should not be viewed as a conclusive determination, because the proposed use of a device in a study is the ultimate determinant of the potential risk to subjects. It is unlikely that a device included in the SR category could be deemed NSR due to the inherent risks associated with most such devices.

Significant RiskNon-significant Risk
Surgical LasersDaily Wear Contact Lenses
Respiratory VentilatorsDental Filling Materials
Cardiac PacemakersConventional Urology Endoscopes
Laryngeal ImplantsGeneral Urological Catheters
Biliary StentsJaundice Monitors for Infants
Infusion PumpsMenstrual Pads & Tampons (Cotton or Rayon, only)
Intrauterine DevicesWound Dressings
Corneal ImplantsElectroencephalography

Investigational Use of Marketed  Medical Devices

The investigational use of approved, marketed devices requires consideration of whether an IND is required. When the principal intent of the investigational use of a medical device is to develop information about the product's safety or efficacy, submission of an IND or IDE may be required. Investigators interested in studying the above are also required to address additional information in Kuali Research (KR) Protocols when completing the IRB application or when requesting an amendment to an IRB-approved study.

Control of Investigational Devices

Research involving the use of investigational test articles (i.e., investigational drugs, biologics or devices) requires that the Investigator or other appropriate individual or entity (e.g., hospital pharmacy), provide appropriate control of test articles.

Note: An Investigational Device Accountability Log must be maintained, if the study includes a device.

UCIMC Policy for Control of Investigational Devices

Investigational devices are carefully regulated and must be appropriately managed by a qualified Investigator or other appropriate individual to ensure they are not co-mingled with similar approved devices. UCI Health Systems Control of Investigational Devices Policy can be found on the UCIMC website.

Lead Researcher (Investigator) Responsibilities

Lead Researchers (Investigators) conducting studies in which an investigational device will be used must ensure adequate control of the device. Adequate control and handling of investigational devices include all of the following:

  • The investigator must ensure that the investigational device is used only in accordance with the UCI IRB approved protocol, the signed agreement, the investigational plan and applicable FDA regulations.
  • The investigator must administer the investigational device only to participants under the investigator’s direct personal supervision or under the supervision of a sub-investigator directly responsible to the investigator.
  • The investigator must not supply the investigational device to any person not authorized to receive it.
  • The investigator must maintain the following accurate, complete, and current records relating to their participation in the clinical investigation (a sample Device Accountability Log is available). Specifically, records of receipt, use or disposition of a device that relate to:
    • The type and quantity of the device, the dates of its receipt, and the batch number or code mark.
    • The names of all persons who received, used, or disposed of each device.
    • Why and how many units of the device have been returned to the sponsor, repaired, or otherwise disposed of.
  • If the investigation is terminated, suspended, discontinued, or completed, the investigator must return any unused stock of the investigational device to the study sponsor, or otherwise provide for disposition of the unused stock as directed by the sponsor.