Creighton University



1. Purpose

This policy documents the procedures for review of medical device studies in accordance with 21 CFR 50, 56, and 812.

1. Clinical investigations of medical devices must comply with the FDA informed consent and IRB regulations (21 CFR 50 and 56). Except for certain low-risk devices, each manufacturer that wishes to introduce a new medical device to the market must submit a pre-market notification to the FDA. The FDA reviews these notifications to determine whether the new device is “substantially equivalent” to a device that was marketed prior to the passage of the Medical Device Amendment of 1976 and the Safe Medical Devices Act of 1990 (“pre-amendments device”). If the new device is deemed substantially equivalent to a pre-amendment device, it may be marketed immediately and is regulated in the same regulatory class as the pre-amendment device to which it is equivalent. If the FDA determines that the new device is not substantially equivalent to a pre-amendment device, it must undergo clinical testing and pre-market approval before it can be marketed, unless it is reclassified into a lower regulatory class.

2. Clinical investigations undertaken to develop safety and efficacy data for medical devices must be conducted according to the requirements of the Investigational Device Exemption (IDE) regulation (21 CFR 812). Certain clinical investigations of devices may be exempt from the IDE regulation (21 CFR 812.12[c]). An investigational device must be categorized as either “significant risk” or “non-significant risk,” unless exempt from the IDE regulation.

2. Definitions

1. A medical device is defined as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory that is:

1. recognized in the official National Formulary or the United States Pharmacopoeia, or any supplement to them

2. 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

3. intended to affect the structure or any function of the body of man or other animals, and that does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals, and that is not dependent upon being metabolized for the achievement of any of its primary intended purposes

2. If a medical device is also a radiation-emitting product (e.g., laser products with medical claims), the device is subject to FDA regulation for both medical devices and radiation-emitting products.

3. Determining the Risk Category of an Investigational Device

The sponsor of a proposed study involving an investigational device makes the initial determination of whether the device presents a non-significant or significant risk. If the sponsor determines the device presents a non-significant risk, the study should be submitted to the IRB for review. If the sponsor determines the device presents a significant risk, the sponsor must first apply for an IDE from the FDA before submitting to the IRB.

After the risk determination has been made, the IRB shall review the research study using the same criteria (21 CFR 56.111) applied to any research involving an FDA-regulated product. To ensure that risks to the participants are reasonable in relation to the anticipated benefits, the risks and benefits of the investigation shall be compared to the risks and benefits of alternative devices or procedures. Minutes of IRB meetings shall document the rationale for approval or disapproval of the clinical investigation.

4. EXEMPTIONS FROM THE IDE REQUIREMENT

1. The device fulfills one of the IDE exemption categories (21 CFR 812.2[c]):

1. A device, other than a transitional device, in commercial distribution immediately before May 28, 1976, when used or investigated in accordance with the labeling in effect at that time.

2. A diagnostic device, if the sponsor complies with applicable requirements in 21 CFR 809.10(c) and if the testing:

1. Is noninvasive

2. Does not require an invasive sampling procedure that presents significant risk

3. Does not by design or intention introduce energy into a participant

4. Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure.

3. 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 participants at risk.

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.

4. ABBREVIATED IDE REQUIREMENT

1. The device fulfills the requirements for an abbreviated IDE (21 CFR 812.2[b][1]):

2. The device is not a banned device

3. The sponsor labels the device in accordance with 21 CFR 812.5

4. The sponsor obtains IRB approval of the investigation after presenting the reviewing IRB with a brief explanation of why the device is not a significant risk device, and maintains such approval

5. The sponsor ensures each investigator participating in an investigation of the device obtains from each participant under the investigator’s care consent under 21 CFR 50 and documents it, unless documentation is waived

6. The sponsor complies with the requirements of 21 CFR 812.46 with respect to monitoring investigations

7. The sponsor maintains the records required under 21 CFR 812.140(b)(4) and (5) and makes the reports required under 21 CFR 812.150(b)(1) through (3) and (5) through (10)

8. The sponsor ensures that participating investigators maintain the records required by 21 CFR 812.140(a)(3)(i) and make the reports required under 812.150(a)(1), (2), (5), and (7)

9. The sponsor complies with the prohibitions in 21 CFR 812.7

5. Non-significant Risk Determination

1. If the sponsor determines that the device presents a non-significant risk, the investigator shall provide the following information from the sponsor to the IRB along with the protocol and informed consent document:

1. Description of the device

2. Reports of prior investigation with the device

3. Proposed investigational plan

4. Description of patient selection criteria and monitoring procedures

5. Any other information the IRB deems necessary to make its decision

6. Statement regarding whether other IRBs have reviewed the proposed study and what determination was made

7. Any FDA assessment of the device’s risk, if such an assessment has been made

2. The IRB shall review the information provided and determine the risk. The determination should be based on the proposed use of the device in an investigation and not on the device alone. If, after review, the IRB agrees with the sponsor’s initial determination that the device presents a non-significant risk, the IRB shall continue with its review of the proposed study.

3. If the IRB does not agree that the device should be classified as a non-significant risk device, the review shall be put on hold and the IRB shall notify the Principal Investigator and the sponsor of its determination. The sponsor shall then be required to submit the device study to the FDA for review. If the FDA determines the device presents a non-significant risk, the IRB shall continue with its review of the study. If the FDA determines the device presents a significant risk, the sponsor shall then apply for an IDE from the FDA. The FDA has the ultimate authority in determining whether a device study presents a non-significant or significant risk.

4. If a non-significant risk device study qualifies as a “minimal risk” study, the IRB may choose to review it using the expedited review procedures outlined in IRB Policy, “Expedited Categories,”. In all other cases, the project shall be subject to full IRB review. If the IRB approves the study, the sponsor and Principal Investigator shall comply with the “abbreviated requirements” of the IDE regulation [21 CFR 812.2(b)], informed consent regulations, and IRB regulations. Unless otherwise notified by the FDA, a non-significant risk study is considered to have an approved IDE if the sponsor fulfills the abbreviated requirements. The abbreviated requirements address, among other things, the requirement for IRB approval and informed consent, recordkeeping, labeling, promotion, and study monitoring. Non-significant risk studies may commence immediately following IRB approval.

5. The minutes of IRB meetings shall document the rationale for the IRB’s determination of risk for investigational device studies.

6. Significant Risk Determination

The FDA must review any device categorized as a significant risk device either by the sponsor or by the IRB after initial review. If the FDA agrees the device presents a significant risk, the sponsor shall obtain an IDE from the FDA. The Principal Investigator shall have an IDE and IRB approval before proceeding with clinical studies. The IRB shall not give final approval until the IDE has been received from the FDA.

Significant risk device studies shall be conducted in accordance with the full IDE regulation [21 CFR 812] and shall not be commenced until: 1) 30 days after the FDA receives the IDE application or the FDA approves, by order, an IDE for the investigation, and 2) the IRB has approved the study. The FDA considers all significant risk studies to present more than minimal risk, and thus full IRB review is necessary.

7. Humanitarian Use Device (HUD)

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

1. Humanitarian Device Exemption (HDE)

1. A Humanitarian Device Exemption (HDE) is an FDA approval for a physician to use an HUD in the clinical treatment of patients. All the following FDA requirements must be met for FDA to approve an HDE:

1. The device is to be used to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year

2. The device would not otherwise be available unless an HDE application were approved

3. No comparable device, other than another HUD approved under the HDE regulation or a device being studied under an approved IDE, is available to treat or diagnose the disease or condition

4. The device will not expose patients to an unreasonable or significant risk of illness/injury, and the probable benefit to health from using the device outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.

8.2. Procedure

The Creighton University IRB (IRB-01) shall review and approve the use of all HUDs. The IRB does not generally require review/approval of each individual use of an HUD device as long as the uses of the device fall into the FDA-approved indication and IRB protocol approval, as applicable.

3. Initial IRB Review/Approval

1. HUD use shall be reviewed and approved by the full board prior to the initial use of the device at a facility operating under the jurisdiction of the Creighton University IRB. The physician requesting initial use of a HUD device shall include the following forms in addition to the Initial Application:

1. The HUD product labeling, clinical brochure, and/or other pertinent informational materials;

2. The FDA HDE approval letter; and

3. Information sheets (a research consent form is not required).

Note: Because the use of an HUD is for diagnosis or treatment purposes only, the HIPAA regulations for research are not applicable. Therefore, a HIPAA Research Authorization and/or Waiver of Authorization is not required.

4. Continuing IRB Review/Approval

1. Continuing review of HUD use by the IRB is required at least annually. For continuing review, IRBs may use the expedited review procedures (21 CFR 56.110)

2. Additional information regarding the FDA requirements for medical devices may be found online at under “science and research (medical devices).

8. EXAMPLES OF NON-SIGNIFICANT RISK DEVICES AND SIGNIFICANT RISK DEVICES

The following examples are provided to assist sponsors and Institutional Review Boards (IRBs) in determining the appropriate risk category (i.e., non-significant or significant) for medical devices. The list includes many commonly used medical devices. Inclusion of a device in the non-significant risk 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 participants. It is unlikely that a device included in the significant risk category could be deemed a non-significant risk device because of the inherent risks associated with most such devices.

Non-Significant Risk Devices

• LOW-POWER LASERS FOR TREATMENT OF PAIN

• 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 general hospital catheters (long-term percutaneous, implanted, subcutaneous, and intravascular)

• Conventional implantable vascular access devices (ports)

• Conventional laparoscopes, culdoscopes, and hysteroscopes

• Dental filling materials, cushions, or pads made from traditional materials and designs

• Dental repair kits and realigners

• Digital mammography (Note: an IDE is required when safety and effectiveness data that will be submitted in support of a marketing application are collected.)

• 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

• Manual image-guided surgery

• Menstrual pads (cotton or rayon, only)

• Menstrual tampons (cotton or rayon, only)

• Non-implantable electrical incontinence devices

• Non-implantable 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)

Significant Risk Devices

GENERAL MEDICAL USE

Catheters

• Urology – urologic with anti-infective coatings

• General hospital – except for conventional long-term percutaneous, implanted, subcutaneous, and intravascular

• Neurological – cerebrovascular, occlusion balloon

• Cardiology – transluminal coronary angioplasty, intra-aortic balloon with control system

Anesthesiology

• Breathing gas mixers

• Bronchial tubes

• Electroanesthesia apparatus

• Epidural and spinal catheters

• Epidural and spinal needles

• Esophageal obturators

• Gas machines for anesthesia or analgesia

• High-frequency jet ventilators greater than 150 BPM

• Rebreathing devices

• Respiratory ventilators

• Tracheal tubes

Cardiovascular

• Aortic and mitral valvuloplasty catheters

• Arterial embolization devices

• Cardiac assist devices: artificial heart (permanent implant and short-term use)

• Cardiomyoplasty devices, intra-aortic balloon pumps, ventricular assist devices

• Cardiac bypass devices: oxygenators, cardiopulmonary non-roller blood pumps, closed chest devices

• Cardiac pacemaker/pulse generators: antitachycardia, esophageal, external transcutaneous, implantable

• Cardiopulmonary resuscitation (CPR) devices

• Cardiovascular/intravascular filters

• Coronary artery retroperfusion systems

• Coronary occluders for ductus arteriosus, atrial and septal defects

• Coronary and peripheral arthrectomy devices

• Extracorporeal membrane oxygenators (ECMO)

• Implantable cardioverters/defibrillators

• Laser coronary and peripheral angioplasty devices

• Myoplasty laser catheters

• Organ storage/transport units

• Pacing leads

• Percutaneous conduction tissue ablation electrodes

• Peripheral, coronary, pulmonary, renal, vena caval, and peripheral stents

• Replacement heart valves

• Radiofrequency (RF) catheter ablation and mapping systems

• Ultrasonic angioplasty catheters

• Vascular and arterial graft prostheses

• Vascular hemostasis devices

Dental

• Absorbable materials to aid in the healing of periodontal defects and other maxillofacial applications

• Bone morphogenic proteins with and without bone, e.g., hyrdoxyapatite (HA)

• Dental lasers for hard tissue applications

• Endosseous implants and associated bone filling and augmentation materials used in conjunction with the implants

• Subperiosteal implants

• Tempormandubular joint (TMJ) prostheses

Ear, Nose, and Throat

• Auditory brainstem implants

• Cochlear implants

• Laryngeal implants

• Total ossicular prosthesis replacements

Gastroenterology and Urology

• Anastomosis devices

• Balloon dilation catheters for benign prostatic hyperplasia (BPH)

• Biliary stents

• Components of water treatment systems for hemodialysis

• Dialysis delivery systems

• Electrical stimulation devices for sperm collection

• Embolization devices for general urological use

• Extracorporeal circulation systems

• Extracorporeal hyperthermia systems

• Extracorporeal photopheresis systems

• Femoral, jugular, and subclavian catheters

• Hemodialyzers

• Hemofilters

• Implantable electrical urinary incontinence systems

• Implantable penile prostheses

• Injectable bulking agents for incontinence

• Lithotripters (e.g., electrohydraulic extracorporeal shock wave, laser, powered mechanical, ultrasonic)

• Mechanical hydraulic urinary incontinence devices

• Penetrating external penile rigidity devices with components that enter the vagina

• Peritoneal dialysis devices

• Peritoneal shunt

• Plasmapheresis systems

• Prostatic hyperthermia devices

• Urethral occlusion devices

• Urethral sphincter prostheses

• Urological stents (e.g., ureteral, prostate)

General and Plastic Surgery

• Absorbable adhesion barrier devices

• Absorbable hemostatic agents

• Artificial skin and interactive wound and burn dressings

• Injectable collagen

• Implantable craniofacial prostheses

• Repeat access devices for surgical procedure

• Sutures

• Collagen implant material for use in ear, nose, and throat; orthopedics; plastic surgery; and urological and dental applications

• Surgical lasers for use in various medical specialties

• Tissue adhesives for use in neurosurgery, gastroenterology, ophthalmology, general and plastic surgery, and cardiology

General Hospital

• Implantable vascular access devices (ports) – if new routes of administration or new design

• Infusion pumps (implantable and closed-loop – depending on the infused drug)

Neurological

• Electricoconvulsive therapy (ECT) devices

• Hydrocephalus shunts

• Implanted intracerebral/subcortical stimulators

• Implanted intracranial pressure monitors

• Implanted spinal cord and nerve stimulators and electrodes

Obstetrics and Gynecology

• Antepartum home monitors for non-stress tests

• Antepartum home uterine activity monitors

• Catheters for chorionic villus sampling (CVS)

• Catheters introduced into the fallopian tubes

• Cervical dilation devices

• Contraceptive devices

- Cervical caps

- Condoms (for men) made from new materials (e.g., polyurethane)

- Contraceptive in vitro diagnostics (IVDs)

- Diaphragms

- Female condoms

- Intrauterine devices (IUDs)

- New electrosurgical instruments for tubal coagulation

- New devices for occlusion of the vas deferens

- Sponges

- Tubal occlusion devices (bands or clips)

• Devices to prevent postoperative pelvic adhesions

• Embryoscopes and devices intended for fetal surgery

• Falloposcopes and falloposcopic delivery systems

• Intrapartum fetal monitors using new physiological markers

• New devices to facilitate assisted vaginal delivery

• Thermal systems for endometrial ablation

Ophthalmics

• Class III ophthalmic lasers

• Contact lens solutions intended for direct instillation (e.g., lubrication/rewetting solutions) in the eye using new active agents or preservatives with no history of prior ophthalmic/contact lens use or not generally recognized as safe for ophthalmic use

• Corneal implants

• Corneal storage media

• Epikeratophakia lenticules

• Extended-wear contact lens

• Eye valve implants (glaucoma implant)

• Intraocular lenses (IOLs) [21 CFR Part 813]

• Keratoprostheses

• Retinal reattachment systems: fluids, gases, perfluorocarbons, perfluorpropane, silicone oil, suflur hexafluoride, tacks

• Viscosurgical fluids

Orthopedics and Restorative

• Bone growth stimulators

• Calcium tri-phosphate hydroxyapatite ceramics

• Collagen and bone morphogenic protein meniscus replacements

• Implantable prostheses (ligament, tendon, hip, knee, finger)

• Computer-guided robotic surgery

Radiology

• Boron neutron capture therapy

• Hyperthermia systems and applicators

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download