Docstoc

NOTE

Document Sample
NOTE Powered By Docstoc
					IUPUI/Clarian Institutional Review Board (IRB) Checklist for Determining When an IDE is Required
Principal Investigator: IRB Study #: Study Title: When the principal intent of the investigational use of a test article is to develop information about the product's safety or efficacy, submission of an Investigational Device Exemption application (IDE) ordinarily must be submitted. However, in certain circumstances, FDA does not require an IDE. This checklist is intended to help you determine whether an IDE is required, and to document the basis of your conclusion so that the IRB will be fully informed.

NOTE:

Please type only in the gray boxes. To mark a box as checked, double-click the box, select “checked”, and click “OK”.
1. EMERGENCY RESEARCH Do you plan to conduct a study of a device involving an exception to the requirement that subjects give informed consent (ref. 21 CFR 312.2(b)(6) and 21 CFR 50.24)? YES. An IDE is required. Even if an IDE already exists for the same device, a separate IDE is required. An amen dment to an existing IDE may not be submitted (ref 21 CFR 50.24(d)). You do not need to continue with this checklist. NO. Please continue. 2. DEVICES Depending on the characteristics of the investigational device and the investigation, investigations of devices fall into one of three categories: exempt, studies of non-significant risk devices subject to abbreviated IDE requirements, or significant risk devices subject to full IDE requirements. Exempt studies are subject only to the clinical investigator disqualification regulations contained in 21 CFR 812.119. However, exempt studies must comply with FDA requirements for IRB review (ref. 21 CFR 56) and informed consent (ref. 21 CFR 50). Studies of non-significant risk devices are subject to abbreviated IDE requirements. An IDE submission is not required under the abbreviated requirements, but the requirements for labeling, informed consent, monitoring, records and reports, and promotion al practices contained in FDA regulations still apply (ref. §812.2(b)). In addition, the concept of "non-significant risk" to determine whether abbreviated IDE procedures are appropriate should not be confused with "minimal risk" to determine whether expedited IRB review is appropriate. For a device s tudy to be eligible for expedited IRB review, it must be a non-significant risk device AND present no more than minimal risk to the subject (ref. §56.110). Studies of significant risk devices are subject to the full IDE requirements found in 21 CFR 812. Some of the questions below require the exercise of scientific/medical judgment. When judgment is required to answer a question, space is provided for you to explain how you reached your conclusion. This information will enable the IRB to review your determination about the need for an IDE. 1. Will the study investigate a device that is the subject of a cleared 510(k) (ref §812(c)(1))? NO. Go to section 2. YES. Please answer the following question. 1.a. Will the device be used in the study in accordance with the FDA-cleared indications for the device (ref. §812(c)(1))? YES. This study is exempt. You do not need to submit an IDE for this study. You do not need to continue with the checklist. NO. Please continue to section 2.

IUPUI/Clarian Institutional Review Board (IRB) Checklist for Determining When an IDE is Required
2. Will the study investigate a diagnostic device? NO. Go to section 3. YES. Please answer the following questions. 2.a. Is the test device non-invasive (ref. §812.2(c)(3)(i))? NO YES 2.b. Does the test device require an invasive sampling procedure that presents a significant risk (ref. §812.2(c)(3)(ii)? NO YES Please explain: 2.c. Does the test device, by design or intention, introduce energy into a subject (ref. §812.(c)(3)(iii)): NO YES 2.d. Will the study compare the test device to another, medically established diagnostic product or proced ure (ref. §812.2(c)(3)(iv))? NO YES 2.e. Will the test device be labeled for research or investigational use only, in accordance with FDA requirements (ref. §809.10(c)(2))? NO YES If you answered NO to questions 2.a, 2.b, and 2.c and YES to questions 2.d and 2.e, the study is exempt from the IDE regulations. You do not need to submit an IDE for this study. You do not need to continue with this checklist. If you answered YES to questions 2.a, 2.b, or 2.c and NO to EITHER question 2.d or 2.e, please continue to section 3. 3.a. Will the study only investigate consumer preferences with respect to the device? YES NO 3.b. Will the study test a modification of an approved or cleared device? YES NO If you answered YES to either question, the study is exempt from the IDE regulations. You do not need to submit an IDE for this study. You do not need to continue with this checklist. If you answered NO to both questions, please continue to section 4. 4. Is the study an investigation of two or more devices in commercial distribution? NO. Go to section 5. YES. Please answer the following questions. 4.a. Is the study intended to determine safety or effectiveness of the devices when used together? YES NO IDE Checklist – Page 2 of 7 v05/01/09

IUPUI/Clarian Institutional Review Board (IRB) Checklist for Determining When an IDE is Required
4.b. Does the use of the devices together put subjects at risk? YES NO Please explain: If you answered NO to both questions, the study is exempt from the IDE regulations. You do not need to submit an IDE for this study. You do not need to continue with this checklist. If you answered YES to either question, please continue to section 5. 5. Is your device a custom device (ref. §812.3(b))? NO. Go to section 6. YES. Please answer the following question. 5.a. Is the custom device being studied to determine the safety and effectiveness of the device for commercial distribution? NO. The study is exempt from the IDE regulations. You do not need to submit an IDE for this study. You do not need to continue with this checklist. YES. Please continue to section 6. 6. Significant and Non-Significant Risk Devices 6.a. Is the device a banned device (ref. §812.2(b) & 21 CFR 895)? YES NO 6.b. Is the device an implant (a device placed into a surgically or naturally formed cavity of the human body, and intended to remain there for a period of 30 days or more) (ref. §812.3(d)) that presents a potential for serious risk to the health, safety, or welfare of the subject (ref. §812(m)(1))? YES NO 6.c. Is the device purported or represented to be for use in supporting or sustaining human life and presents a potential for seri ous risk to the health, safety, or welfare of a subject (ref. §812.3(m)(2))? YES NO 6.d. Is the device for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preven ting impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject (ref. §812.3(m)(3))? YES NO If you answered YES to any of the questions above, your device is a significant risk device and an IDE must be submitted for this study. You do not need to continue with this checklist. If you answered NO to all of the questions above, please continue to section 7. 7. Does your device present a potential for serious risk to the health, safety, or welfare of a subject in a way other than those described in Section 6 (ref 21 CFR 812.3(m)(4))? YES NO Please explain:

Points to Consider: A risk determination should be based on the device itself, and the proposed use of the device. A device may pose a significant risk for IDE Checklist – Page 3 of 7 v05/01/09

IUPUI/Clarian Institutional Review Board (IRB) Checklist for Determining When an IDE is Required
some uses, but not for others. A risk determination should consider the nature of the harm that may result from the use of the device. What is the risk to the subject if the device fails? A risk determination should consider whether the subject will need to undergo an additional procedure as part of the investigational study, such as a surgical procedure. FDA has published a list of examples of significant risk devices, and non-significant risk devices (see Appendix A for list). The inclusion of the type of device you are studying on one of the lists may be helpful in determining whether your device is a significant or non-significant risk device. However, it should be noted that inclusion of a device on the list of non-significant risk devices is not a final determination because the evaluation of risk must reflect the proposed use of the device in a study. If you answered YES to question 7, your device is a significant risk device and an IDE must be submitted for this study. If you answered NO to question 7, you have concluded that the device used in the study is a non-significant risk device. The IRB will review your conclusion and notify you if it concludes that the device is a significant risk device requiring the submiss ion of an IDE (ref. §812.65(a)(5)). If the IRB agrees with your conclusion that the device is a non-significant risk device, you may follow abbreviated IDE requirements (ref. §812.2(b)). The abbreviated IDE requirements do not require submission of an IDE to FDA. However, you must still comply with the following FDA regulations: 21 CFR 812.5 – Labeling of Investigational Device 21 CFR 812.46 – Monitoring Investigations 21 CFR 812.140– Records and Reports 21 CFR 812 150 – Records and Reports 21 CFR 812.7 – Prohibition of Promotion and other Practices You should review these regulations and ensure your compliance with them. X. EXAMPLES OF NSR AND SR DEVICES The following examples may help sponsors and IRBs in making SR and NSR determinations. The list includes many commonly studied medical devices. Inclusion of a device in the NSR list is not a final determination because the evaluation of risk must reflect the proposed use of a device in a study. A. Nonsignificant Risk Devices              Caries Removal Solution 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 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) Dental Filling Materials, Cushions or Pads made from traditional materials and designs Denture Repair Kits and Realigners Digital Mammography Electroencephalography (e.g., new recording and analysis methods, enhanced diagnostic capabilities, measuring depth of anesthesia if anesthetic administration is not based on device output) Externally Worn Monitors for Insulin Reactions Functional Non-Invasive Electrical Neuromuscular Stimulators v05/01/09

IDE Checklist – Page 4 of 7

                

General Biliary Catheters General Urological Catheters (e.g., Foley and diagnostic catheters) for short term use (< 28 days) Jaundice Monitors for Infants Low Power Lasers for treatment of pain 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) Nonimplantable Electrical Incontinence Devices Nonimplantable Male Reproductive Aids with no components that enter the vagina Ob/Gyn Diagnostic Ultrasound within FDA approved parameters Partial Ossicular Replacement Prosthesis (PORP) Total Ossicular Replacement Prosthesis (TORP) Transcutaneous Electric Nerve Stimulation (TENS) Devices for treatment of pain (except for chest pain/angina) Ureteral Stents Urethral Occlusion Device for less than 14 days Wound Dressings, excluding absorbable hemostatic devices and dressings (also excluding Interactive Wound and Burn Dressings that aid or are intended to aid in the healing process) B. Significant Risk Devices

1. General Medical Use  Catheters for General Hospital Use - except for conventional long-term percutaneous, implanted, subcutaneous and intravascular  Collagen Implant Material for use in ear, nose and throat, orthopedics, plastic surgery, 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 2. 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 Ventilators greater than 150 BPM  Rebreathing Devices  Respiratory Ventilators and new modes of ventilation  Tracheal Tubes 3. Cardiovascular  Annuloplasty Rings  Aortic and Mitral Valvuloplasty Catheters  Arterial Embolization Devices  Atherectomy and Thrombectomy Catheters  Cardiac Assist Devices: artificial hearts, ventricular assist devices, intra-aortic balloon pumps, cardiomyoplasty devices  Cardiac Bypass Devices: oxygenators, cardiopulmonary blood pumps, axial flow pumps, closed chest devices (except Class I cardiovascular surgical instruments), heat exchangers, catheters/cannulae, tubing, arterial filters, reservoirs  Cardiac Mapping and Ablation Catheters  Cardiac Pacemaker/Pulse Generators: antitachycardia, esophageal, external

                   

transcutaneous, implantable Cardiopulmonary Resuscitation (CPR) Devices Cardiovascular Intravascular (vena cava) Filters Coronary Artery Retroperfusion Systems Distal Embolic Protection Devices Extracorporeal Counterpulsation Devices Extracorporeal Membrane Oxygenators (ECMO) Implantable Cardioverters/Defibrillators Intravascular Brachytherapy Devices Intravascular Stents Laser Angioplasty Catheters Organ Storage/Transport Units Pacing Leads Percutaneous Conduction Tissue Ablation Electrodes Percutaneous Transluminal Angioplasty Catheters Replacement Heart Valves Transcatheter Cardiac Occluders for atrial and ventricular septal defects, patent foramen ovale and patent ductus arteriosus Transmyocardial Revascularization, Percutaneous Myocardial Revascularization Devices Ultrasonic Angioplasty Catheters Vascular and Arterial Graft Prostheses Vascular Hemostasis Devices

4. Dental  Absorbable Materials to aid in the healing of periodontal defects and other maxillofacial applications  Bone Morphogenic Proteins with and without bone, e.g., Hydroxyapatite (HA)  Dental Lasers for hard tissue applications  Endosseous Implants and associated bone filling and augmentation materials used in conjunction with the implants  Subperiosteal Implants  Temporomandibular Joint (TMJ) Prostheses 5. Ear, Nose And Throat  Absorbable Gelatin Sponge  Auditory Brainstem Implants

List taken from FDA Information Sheet Guidance – SR and NSR Medical Device Studies (Jan 2006)

Page 5

         

Cochlear Implants Endolymphatic Shunt Tubes with or without valve ENT Cements/Adhesives Implantable Bone Conduction Hearing Aids Implantable Middle Ear Hearing Device Injectable Teflon Paste Laryngeal Implants Synthetic Polymer Materials Tissue Autofluorescent Devices Vocal Cord Medialization (Augmentation) Devices

depending on the infused drug) 9. Neurological  Electroconvulsive Therapy (ECT) Devices  Hydrocephalus Shunts  Implanted Intracerebral/Subcortical Stimulators  Implanted Intracranial Pressure Monitors  Implanted Spinal Cord and Nerve Stimulators and Electrodes  Neurological Catheters (e.g., cerebrovascular, occlusion balloon, etc.)  Transcutaneous Electric Nerve Stimulation (TENS) Devices for treatment of chest pain/angina 10. Obstetrics And Gynecology  Abdominal Decompression Chamber  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)  Cryomyolysis  Devices to Prevent Post-op Pelvic Adhesions  Embryoscopes and Devices intended for fetal surgery  Endometrial Ablation Systems  Falloposcopes and Falloposcopic Delivery Systems  Fundal Pressure Belt (for vaginal assisted delivery)  Gamete and Embryo Surgical Systems  Intrapartum Fetal Monitors using new physiological markers  New Devices to Facilitate Assisted Vaginal Delivery  Operative Hysteroscopy and Laparoscopy  Uterine Artery Embolization 11. Ophthalmics  Aniridia Intraocular Lenses (IOLs) or Rings (for iris reconstruction)  Capsular Tension Rings  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 Storage Media  Extended Wear Contact Lens (i.e., including a single overnight use)  Glaucoma Treatment Devices (e.g., trabeculoplasty devices, devices that treat ciliary bodies, devices that

6. 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 or Thermal Ablation Devices  Retention Type (Foley) Balloon Catheters for long term use (> 28 days)  Suprapubic Urological Catheters and accessories  Urethral Occlusion Devices for greater than 14 days use  Urethral Sphincter Prostheses  Urological Catheters with anti-microbial coatings  Urological Stents (e.g., urethral, prostate, etc.) 7. General And Plastic Surgery  Absorbable Adhesion Barrier Devices  Absorbable Hemostatic Agents  Artificial Skin and Interactive Wound and Burn Dressings  Breast Implants  Injectable Collagen  Implantable Craniofacial Prostheses  Repeat Access Devices for surgical procedures  Sutures 8. General Hospital  Implantable Vascular Access Devices (Ports) - if new routes of administration or new design  Infusion Pumps (implantable and closed-loop -

List taken from FDA Information Sheet Guidance – SR and NSR Medical Device Studies (Jan 2006)

Page 6

   



 



raise or lower intraocular pressure, aqueous shunt/drainage devices, etc.) Implants for Refractive Purposes (e.g., intraocular lenses, corneal implants, scleral expansion bands, etc.) Intraocular Lenses (IOLs) Keratoprostheses Refractive Surgical Devices (e.g., lasers, electrical current devices, thermal and non-thermal keratoplasty devices, ablation devices, expansion rings, treatment of ciliary bodies, etc.) Retinal Disease Treatment Devices (e.g., electrical stimulation devices to treat macular degeneration, lasers to ablate epiretinal membranes and vitreous strands, etc.) Retinal Prosthesis (implant) Retinal Reattachment Devices (e.g., fluids, gases, perfluorocarbons, perfluorpropane, silicone oil, sulfur hexafluoride, balloon catheter for retinal reattachment) Viscosurgical Fluids (viscoelastics)

12. Orthopedics And Restorative  Anti-Adhesion Gels  Bone Growth Stimulators  Bone Morphogenetic Proteins/Biodegradable Scaffolds combination products, with or without allograft/autograft combinations and with or without metallic implant  Bone Void Fillers (hydroxyapatite and other materials)  Bovine Collagen Meniscus Implants  Computer Guided Robotic Surgery  Implantable Peripheral Neuromuscular Stimulators  Implantable Prostheses (ligament, tendon, hip, knee, finger)  Implantable Spinal Devices  Injectable Sodium Hyaluronate 13. Radiology  Boron Neutron Capture Therapy  Hyperthermia Systems and Applicators

Also see the FDA Information Sheet Guidance on “Frequently Asked Questions about Medical Devices.”

List taken from FDA Information Sheet Guidance – SR and NSR Medical Device Studies (Jan 2006)

Page 7


				
DOCUMENT INFO
Shared By:
Categories:
Stats:
views:11
posted:1/30/2010
language:English
pages:7