Medical Devices

Investigational Device is a medical device that is the subject of a clinical study designed to evaluate the effectiveness and/or safety of the device. As further stated, a device is any healthcare product that does not achieve its primary intended purpose by chemical action or by being metabolized. IDE means an investigational device exemption in accordance with 21 CFR 812..

Significant Risk (SR). 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
  • Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

Non-Significant Risk (NSR). A non-significant risk device is an investigational device other than a significant risk device.

Humanitarian Use Device (HUD). Humanitarian Use Device is a device intended to benefit patients by treating or diagnosing a disease that affects fewer than 4,000 individuals in the United States per year.

The Principal Investigator/ Sponsor must indicate on the IRB application whether the research involves investigational devices. If so, the PI/ Sponsor must indicate if there is an IDE for the research and provide documented assurance from the sponsor that the manufacture and formulation of investigational or unlicensed test articles conform to federal regulations. Documentation of the IDE could be a:

  • intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject.
  • Letter from FDA.
  • Letter from industry sponsor.
  • Other document and/or communication verifying the IDE.

For investigational devices, NSR (Non-Significant Risk) device studies follow abbreviated IDE requirements and do not have to have an IDE application approved by the FDA. If a sponsor has identified a study as NSR, then the investigator must provide an explanation of the determination. If the FDA has determined that the study is NSR, documentation of that determination must be provided. If the research involves devices and there is no IDE, the PI must provide a rationale why it is not required.
The IRB will review the application and determine whether there is an IDE and if so, whether there is appropriate supporting documentation.

Exempted IDE Investigations:

For devices, an IDE is not necessary if:

  • The research involves a device, other than a transitional device, in commercial distribution immediately before May 28, 1976, when used or investigated in accordance with the indications in labeling in effect at that time;
  • The research involves a device that FDA has determined to be substantially equivalent to a device in commercial distribution immediately before May 28, 1976, and that is used or investigated in accordance with the indications in the labeling FDA reviewed under subpart E of 21 CFR 807 in determining substantial equivalence;
  • The research involves a diagnostic device, if the sponsor complies with applicable requirements in 21 CFR 809.10(c) and if the testing:
    a)
    Is noninvasive,
    b) Does not require an invasive sampling procedure that presents significant risk,
    c) Does not by design or intention introduce energy into a subject, and
    d) Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure;
  • The research involves a device undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution, if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk;
  • The research involves a device intended solely for veterinary use;
  • The research involves a device shipped solely for research on/or with laboratory animals and labeled in accordance with 21 CFR 812.5(c);

The research involves a custom device as defined in 21 CFR 812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution.

Examples of Non significant Risk devices (NSR):

  • Low Power Lasers for treatment of pain (Note: an IDE is required when safety and effectiveness data are collected which will be submitted in support of a marketing application.)
  • Caries Removal Solution
  • Daily Wear Contact Lenses and Associated Lens Care Products not intended for use directly in the eye (e.g., cleaners; disinfecting, rinsing and storage solutions)
  • Contact Lens Solutions intended for use directly in the eye (e.g., lubricating/rewetting solutions) using active ingredients or preservation systems with a history of prior ophthalmic/contact lens use or generally recognized as safe for ophthalmic use.
  • Conventional Gastroenterology and Urology Endoscopes and/or Accessories
  • Conventional Laparoscopes, Culdoscopes, and Hysteroscopes
  • Dental Filling Materials, Cushions or Pads made from traditional materials and designs
  • Denture Repair Kits and Realigners
  • Digital Mammography (Note: an IDE is required when safety and effectiveness data are collected which will be submitted in support of a marketing application.)
  • Electroencephalography (e.g., new recording and analysis methods, enhanced diagnostic capabilities)
  • Externally Worn Monitors for Insulin Reactions
  • Functional Electrical Neuromuscular Stimulators
  • General Biliary Catheters
  • General Urological Catheters (e.g., Foley and diagnostic catheters)
  • Jaundice Monitors for Infants
  • Magnetic Resonance Imaging (MRI) Devices within FDA specified parameters
  • Menstrual Pads (Cotton or Rayon only)
  • Nonimplantable Electrical Incontinence Devices
  • Nonimplantable Male Reproductive Aids with no components that enter the vagina
  • Ob/Gyn Diagnostic Ultrasound within FDA approved parameters
  • Transcutaneous Electric Nerve Stimulation (TENS) Devices for treatment of pain
  • Wound Dressings, excluding absorbable hemostatic devices and dressings (also excluding Interactive Wound and Burn Dressings)

More information about Medical Devices could be obtained on FDA website and here is a link.
 
 

Awards

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