A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch Paclitaxel Coated Balloon Catheter, in Above the Knee Lesions, Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH), Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS) System for Pulmonary Artery Denervation (PDN) in Patients With Pulmonary Hypertension - US, Efficacy and Safety of LifeSeal Kit for Staple Line Sealing in Colorectal and Coloanal Anastomoses: A Prospective Randomized Study. Study Risk Determination (SRD) Q-Submission: If a SRD Q-Submission (Q-Sub) was submitted, provide the Q-Sub number and a copy of the determination letter provided by the FDA. Investigational Device Exemption (IDE) | FDA If files were not submitted by the sponsor, include a letter from the owner of the files that grants FDA permission to reference the files in its review of the current application. WebThe Pharmaceutical Benefits Advisory Committee (PBAC) considered whether the section 19A approved Ozempic product should be subsidised through the Pharmaceutical Benefits Scheme (PBS). A federal government website managed and paid for by the U.S. Centers for Medicare & Medicaid Services. Records must include documents demonstrating informed consent and, for any use of a device the investigator without informed consent, any written concurrence of a licensed physician and a brief description of the circumstances justifying the failure to obtain informed consent. The sponsor must demonstrate in the application that there is reason to believe that the risks to human subjects from the proposed investigation are outweighed by the anticipated benefits to subjects and the importance of the knowledge to be gained, that the investigation is scientifically sound, and that there is reason to believe that the device as proposed for use will be effective. A sponsor cannot begin a significant risk device investigation until FDA and IRB approval are granted. IDE Records | FDA IDE Records Sponsor Records for Significant Risk Device Does the informed consent form seek consent from the subject or a legally authorized representative, when appropriate (e.g., when the subject is a minor)? Prospective, Randomized, Controlled, Blinded Pivotal Study In Subjects Undergoing A Transforaminal Lumbar Interbody Fusion (TLIF) At One Or Two Levels Using Infuse Bone Graft and The Capstone Spinal System With Posterior Supplemental Fixation For Th Safety and Efficacy of the Slit Stent II Lacrimal Stent for the Treatment of Nasolacrimal Duct Obstruction, Combined Cortical and Subcortical Recording and Stimulation as a Circuit-Oriented Treatment for Obsessive-Compulsive Disorder, A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection, Continued Access Protocol To Evaluate the Effectiveness of the Portable Organ Care System (OCS) Liver for Preserving and Assessing Donor Livers for Transplantation, Chronic Total Occlusion Percutaneous Coronary Intervention CTO-PCI Study, A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of the Optilume BPH Catheter System in Men With Symptomatic BPH, Safety and Effectiveness of Posterior Cervical Stabilization System (PCSS) as an Adjunct to Posterior Cervical Fusion, When Used in Combination With ACDF in Treatment of Multi-level Cervical Degenerative Disease, The Citadel Embolization Device Feasibility Study, Endovascular Therapy for Low NIHSS Ischemic Strokes, Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression, Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain Using Summit RC+S, Magnetic Seizure Therapy In Bipolar Depression (MST-BpD), Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study, Safety and Effectiveness IDE Trial for Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation, ASSURE WCD Clinical Evaluation - Conversion Efficacy Study (ACE-CONVERT), A Prospective, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of PMX Cartridge in Addition to Standard Medical Care for Patients With Endotoxemic Septic Shock, Clinical Evaluation of the HemoCare Hemodialysis System for Home Nocturnal Hemodialysis, A Multicenter, Prospective, Randomized-controlled Trial to Assess the Safety and Feasibility of Cooling as an Adjunctive Therapy to Thrombectomy and Reperfusion in Patients With Acute Cerebral Ischemia and Stroke, Prospective, Multicenter Study Evaluating the Performance and Safety of FRAME, External Support for Lower Limb Autologous Grafts, The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study for Occlusive and Re-stenotic Fem-pop Revascularization - 2 Trial: TORUS 2, A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of the RECELL System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction, Study of the Safety and Effectiveness of the Motiva Implants Silicone Gel-Filled Breast Implants SmoothSilk/SilkSurface in Subjects Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, and Revision Surgery, Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: the PROMISE II Trial, A Prospective, Multi-Center, Randomized, Controlled, Single Blind Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure Patients, iCLAS for Persistent Atrial Fibrillation, Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory. Please refer to our eCopy Guidance Document regarding types of IDE submissions that are exempt from submitting an eCopy. The .gov means its official.Federal government websites often end in .gov or .mil. Recommendations for IDE Submitters, outlines recommendations for the submission process that ensure a smooth transition to these changes. The investigator must notify the sponsor and the reviewing IRB of any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency. Description of the Device: Are the following items provided and adequate? If a submission responds to both SDCs and deficiencies from an approval with conditions or disapproval letter, we will track it as an Amendment. Stakeholders include federal partners like the Department of Defense and the Centers for Disease Control and Prevention, as well as state and local public health agencies. Does the labeling contain adequate information for the purposes of the investigation, in accordance with 812.5(a), including the name and place of business of the manufacturer, packer, or distributor, the quantity of contents, and a description of all relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions? ), detailed description of the conduct of the trial, an analysis of the protocol demonstrating its scientific soundness, a description and analysis of all increased risks to the research subjects, the manner in which risks will be minimized, a description of patient population, including number, age, sex and condition, a description of each important component, ingredient and property, a description of any anticipated changes in the device during the investigation, the written procedure for monitoring the investigation, the name and address of the individual(s) who will monitor the study. Any plans to submit another IDE application for this device or a modification of this device. How many IRBs are currently reviewing the investigation or will review it in the future? WebFood Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Investigators commitment to provide sufficient and accurate financial disclosure information and update information if any relevant changes occur during the investigation and for one year following the completion of the study. Submission reasons tracked as Amendments: The FDA now tracks EUAs and PEUAs separately from IDEs. A submission intended to report the progress of a study also includes a request to change the study protocol. Information that must be included in the written agreement are found in 812.43, Certification that all investigators have signed the agreement, that the list of investigators includes all investigators participating in the study, and that new investigators will sign the agreement before being added to the study, A list of the names, addresses, and chairpersons of all IRBs that have or will be asked to review the investigation and a certification of IRB action concerning the investigation (when available), The name and address of any institution (other than those above) where a part of the investigation may be conducted, The amount, if any, charged for the device and an explanation of why sale does not constitute commercialization, Please note that an environmental assessment as required under 21 CFR 25.40 or a claim for categorical exclusion under 21 CFR 25.30 or 25.34 is no longer required. WebDatabases Premarket approval (PMA) is the FDA process of scientific and regulatory The following information must be included in an IDE application for a significant risk device investigation. The site is secure. Regulations pertaining to the Investigational Device Exemptions (IDE) 21 In addition, the changes may be subject to IRB review procedures under 21 CFR 56.110. If an investigator or sponsor transfers custody of the records to another person, FDA must be notified within 10 working days after the transfer occurs. If a sponsor intends to conduct an investigation that involves an exception to informed consent under 50.24 (see Informed Consent), the sponsor must submit a separate investigational device exemption (IDE) application [812.20(a)]. Changes to devices are deemed to occur on the date the device, manufactured incorporating the design or manufacturing change, is distributed to the investigator(s). Approved IDE Studies. Any plans to change the investigation, e.g., to expand the study size or indications, to discontinue portions of the investigation or to change manufacturing practices (NOTE: Actual proposals for these changes should be made in a separate IDE supplement). .gov Reports are now tracked as a distinct submission type and are no longer considered Supplements. These notices must be identified as a "notice of IDE change.''. Statement that the information provided is an original IDE submission. Multi-Center, Prospective, Randomized, Controlled Clinical Evaluation of the Safety and Effectiveness of the Sight Sciences VISCO360 Viscosurgical System in Canaloplasty Versus Selective Laser Trabeculoplasty in the Reduction of IOP in Primary Open Ang Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreatable Patients, SOLVE CRT, Closing the Loop on Tremor: A Responsive Deep Brain Stimulator for the Treatment of Essential Tremor, Pivotal Clinical Study to Evaluate the Safety and Effectiveness of MANTA Vascular Closure Device. Premarket Approval (PMA) - Food and Drug Administration The following IDE studies have met CMS standards for coverage. a written protocol describing the methodology to be used including: objectives, hypothesis to be tested, or question to be answered, description of the type of trial (i.e., controlled/open, double-blind/single-blind, etc. Waiver Requests: Identify any requests for waivers and include a justification for the waiver. Randomized, Multi-Center Pivotal Study for Sacral Nerve Stimulation to Treat Refractory Urgency Urinary Incontinence With Wireless Neuromodulation Technology, FlowTriever Pulmonary Embolectomy Clinical Study, A Prospective, Multi Center Pilot Study Evaluating Plaque Photoablation Using the RA-308 Excimer Laser in Subjects With Symptomatic Infrainguinal Lower Extremity Vascular Disease, COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV (COMPASSION S3), A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction (Athena), Self-Centering Guide Catheter Feasibility Study, Silver Nitrate-Coated Indwelling Pleural Catheter (SNCIPC), REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients (RESCUE), Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation, Analysis of Prostatic Arterial Embolization for Benign Prostatic Hyperplasia Using Embosphere Microspheres. A sponsor of a significant risk device study must submit a complete IDE application to FDA. The FDA tracks requests for a new protocol, changes to the approved protocol, or changes to the device, such as device design or manufacturing change, as supplements. Starting October 1, 2023, all 510(k) submissions, unless exempted*, must be submitted as electronic submissions using eSTAR. The validity of the data or information in the approved protocol, or the patient risk to benefit relationship relied upon to approve the protocol, The scientific soundness of the investigational plan. Provide the following information, if applicable: Q-Submissions/Pre-Submissions: Describe any discussions with the FDA about this device. Protocol: Are the following items provided and adequate? The .gov means its official.Federal government websites often end in .gov or .mil. Because FDA does require the information listed below, it is suggested that, at a minimum, the annual progress and final reports to the sponsor and the IRB include the following items: An official website of the United States government, : IDE Records | FDA - U.S. Food and Drug Administration A Phase II Study of Induction Systemic mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone Given Concurrently With Systemic mFOLFIRI as a First-Line Therapy in Patients With Unresectable Liver-Dominant Intrahepatic Cholangio EF-32: Pivotal, Randomized, Open-Label Study of Optune (Tumor Treating Fields, 200kHz) Concomitant With Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma, A Prospective, Multi-Center, Single Arm Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke: The EvaQ Study, Feasibility and Safety of Geniculate Artery Embolization for Treatment of Mild to Moderate Knee Osteoarthritis, An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System, Prophylactic Tumor Treating Fields in Management of Patients With Small Cell Lung Cancer, Harpoon Beating Mitral Valve Repair System, A Study of the Embolization of the Middle Meningeal Artery With ONYX Liquid Embolic System In the Treatment of Subacute and Chronic Subdural HEmatoma (EMBOLISE), Safety and Effectiveness of TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) for the Treatment of Drug Refractory, Symptomatic, Paroxysmal Atrial Fibrillation, EUS-guided Gastroenterostomy Versus Enteral Stenting for Palliation of Malignant Gastric Outlet Obstruction: A Randomized Clinical Trial, A Prospective, Multicenter Investigation of the da Vinci Xi Surgical System in Nipple Sparing Mastectomy (NSM) Procedures, An Open Label Study to HemoCare Hemodialysis System for Home Hemodialysis Prior to Market Authorization, A Clinical Investigation to Assess the Abbott Next Generation Drug Eluting Stent 48mm Everolimus Eluting Coronary Stent System (EECSS) in Treatment of de Novo Native Coronary Artery Disease. a statement of the investigator's commitment to: conduct the investigation in accordance with the agreement, the investigational plan, Part 812 and other applicable FDA regulations, and conditions of approval imposed by the reviewing IRB and FDA; supervise all testing of the device involving human subjects; and, ensure that the requirements for obtaining informed consent are met. The current mailing address for CDRHs DCC and a link to CBERs DCCs mailing address are provided on the eCopy Program for Medical Device Submissions webpage. Heres how you know. IDE Regulations | FDA - U.S. Food and Drug Each subsequent submission to an IDE will be assigned to the appropriate study, so that the FDA can track milestones in clinical trial development, IDE approval, study initiation, and study completion. Certification that all participating investigators have signed the agreement and that no investigator will be added until the agreement is signed. These records include: The following records must be maintained in one location and available for FDA inspection under 812.2(b): The sponsor must also maintain records concerning complaints and adverse device effects whether anticipated or not [812.140(b)(5)]. Feasibility Pilot of Hepatic Arterial Infusion Chemotherapy in a Rural Catchment Area, Using the Codman Vascular Catheter With the Synchromed II Pump, for Patients With Unresectable Colorectal Cancer Liver Metastases or Unresectable Intrahepatic Cholangio A Randomized Phase II Study of Systemic Chemotherapy With or Without HAI FUDR/Dexamethasone in Patients With Unresectable Intrahepatic Cholangiocarcinoma, Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea, The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) Study, Promoting Healing Of Nerves Through Electrical Stimulation. In order to facilitate FDA's handling of IDE applications, the following recommendations are offered: The sponsor should assure that the device, all preclinical testing, and the investigational plan are described and provide adequate justification for the initiation of the clinical trial. Report of prior investigations ( 812.27). Study Progress. Because changes to the study protocol require FDA approval prior to implementation and would be deemed approved if a decision is not made within the 30-day review period, the FDA will prioritize review of the change request over review of the report. For more information on FDAs inspection program, see IDE Enforcement of Good Clinical Practices (GCP) Regulations. Post-Approval Studies (PAS) Database - Food and Drug Other Reports: The investigator must provide accurate, complete, and current information about any aspect of the investigation upon request from the reviewing IRB or FDA. The sponsor of an IDE may modify the device and/or clinical protocol without approval of a new IDE application or IDE supplement if the modifications meet certain criteria. Establishment Registration & Device Listing - Food and Drug ( There are no IDE application forms. If the change or deviation may affect the scientific soundness of the investigational plan or the rights, safety or welfare of the subject, the sponsor is required to obtain prior IRB approval and also to obtain FDA approval for a significant risk device investigation by submitting an IDEsupplement. The FDA will continue to review IDE submissions within 30 days and EUA submissions as quickly as possible. Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D): A Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate DrugSorb-ATR Removal of Apixaban and Rivaroxaban to Reduce Likelihood of Serious B A Randomized, Single-Blinded, Non-Inferiority Study Comparing AGN1 Local Osteo-Enhancement Procedure (LOEP) SV Kit Treatment of Vertebral Compression Fragility Fractures to PMMA Bone Cement Treatment, Prospective Randomized Multi-center Controlled Clinical Investigation Comparing Patent Foramen Ovale (PFO) Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion, Randomized, Two-arm, Multicenter Study to Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery, Feasibility of Hemodialysis With the GARNET Device in Chronic Hemodialysis Patients With a Bloodstream Infection. Investigational Devices - Human Research Protection Program Multi-center, Single Arm Continuing Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) for the Management of the Femoral Venotomy After Catheter-based Interventions Performed Via 6-12 Fr Procedural Sheaths With Single o RELIEVE-HF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure, Prospective, Randomized, Multi-Center Study to Evaluate Treatment of Subjects With Occlusive Disease With a Novel Paclitaxel-Coated Angioplasty Balloon in Below-The-Knee (BTK) Arteries - ILLUMENATE BTK, Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects With Mitral Annular Calcification, An Open-Label Clinical Study to Assess the Performance of the Dialyzer With Endexo in End-Stage Renal Disease Subjects, Task and Physiological Specific Stimulation for Recovery of Autonomic Function, Voluntary Movement, and Standing Using Epidural Stimulation and Training After Severe Spinal Cord Injury, A Randomized Trial Comparing the Drug-Eluting Stent (DES) Below-the-Knee (BTK) Vascular Stent System (DES BTK Vascular Stent System) vs Percutaneous Transluminal Angioplasty (PTA) Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia, PHIL dAVF: Study of PHIL Embolic System In The Treatment of Intracranial Dural Arteriovenous Fistulas, OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI, Next-Generation TECNIS Symfony Extended Range of Vision IOL, ROBUST III - Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease - A Randomized Control Trial, LC Bead LUMI for Prostatic Artery Embolization: A Pilot Study, Evaluation of the Tissue Genesis Icellator Cell Isolation System to Treat Erectile Dysfunction, The Mount Sinai Diabetic Foot Ulcer Prospective Trial, A Multicenter, Single-arm Study of Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis With Lumen-Apposing Metal Stents, FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of Ventricular Tachycardia (LESS-VT) Study, A 2x2 Factorial Randomized Controlled Trial of Colchicine and Spironolactone in Patients With ST-elevation Myocardial Infarction (STEMI) / SYNERGY Stent Registry - CLEAR-SYNERGY (OASIS-9), A Validation of the Assisted Fluid Management Feature, A Multi-Center, Prospective Clinical Trial To Evaluate The Safety And Effectiveness of the CT LUCIA 611p Posterior Chamber Intraocular Lens For Correction of Aphakia Following Cataract Removal, EVOLVE 48: A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of the SYNERGY 48 mm Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s), Randomized Controlled Pivotal Trial of Autologous Bone Marrow Cells Using the CardiAMP Cell Therapy System in Patients With Refractory Angina Pectoris and Chronic Myocardial Ischemia (CardiAMP CMI Trial), Treatment With Intent to Generate Endovascular Reperfusion, Safety and Feasibility of Adipose Derived Regenerative Cells (ADRCs) in the Treatment of Deep Partial Thickness and Full Thickness Thermal Wounds (RELIEF), MIND: A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage, INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage: A Prospective Multicenter Registry, INVEST: A Single Arm, Feasibility Study of Minimally Invasive Endoscopic Surgical Treatment With Apollo for Supratentorial Intracerebral Hemorrhage (ICH), Confirmatory Clinical Study to Support the Effectiveness and Safety of Oxiplex for the Reduction of Pain and Symptoms Following Lumbar Surgery, Local Field Potential (LFP) Beta Adaptive Deep Brain Stimulation (aDBS) Feasibility Study, Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Gemcitabine and Nab-paclitaxel for Front-line Treatment of Locally-advanced Pancreatic Adenocarcinoma, Wearable Sensor Driven Closed-loop Deep Brain Stimulation for Essential Tremor, Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation, PQ Bypass System for Femoropopliteal Bypass II, Metabolic Mapping and Cardiac Resynchronization (Aim 1), A Non-Randomized Study Evaluating the Use of the ReFlow Medical Wingman Catheter to Cross Chronic Total Occlusions in Infrainguinal Peripheral ArTeries. This determination is made by the sponsor and must be based on credible information. b. processing Report of Prior Investigations ( 812.27): Are the following items provided and are they comprehensive and adequate to justify the proposed investigation? Therefore,separate initial submissions for reports and requests to change the device or study will result in more timely IDE submission review. Summary of any new adverse information (since the last progress report) that may affect the risk analysis; this includes preclinical data, animal studies, foreign data, clinical studies, etc. The .gov means its official.Federal government websites often end in .gov or .mil. The case history of each individual must document that informed consent was obtained prior to participation in the study. An official website of the United States government, : Statement that submission is an original IDE application. Submission reasons tracked as Reports include: The FDA tracks any IDE submission sent as a response to deficiencies communicated in an FDA disapproval, approval with conditions, or deficient report letter as an IDE Amendment to that submission. Correspondent Information: If the organization submitting the application is not the sponsor, such as a consultant or a lawyer, include contact information for the correspondent organization or individual. Case histories include case report forms and supporting data, including signed and dated consent forms and medical records, including progress notes of the physician, the individuals hospital chart(s), and the nurses notes. Emergency Use FDA approval o Approved IDE Studies | CMS Devices@FDA - Food and Drug Administration [25.34(g)]. October 3, 2022 - The FDA is announcing that you may now send electronic copy (eCopy) or electronic Submission Template And Resource (eSTAR) premarket submissions online through the CDRH Customer Collaboration Portal ("CDRH Portal"). An important part of reaching that goal is to better track milestones in clinical trial development, Investigational Device Exemption (IDE) approval, study initiation, and study completion. A Prospective, Multicenter Clinical Trial of the Implantable Miniature Telescope in Pseudophakic Eyes With Central Vision Impairment Associated With End-Stage Macular Degeneration. There are no preprinted forms for an IDE application; however, an IDE application must include certain required information. [ 812.5(a))], Note: The device may not be promoted as safe and effective for the use for which it is being investigated. Does the consent process involve a "short form" written consent [21 CFR Part 50.27(b)(2))]. The WAVE Study, A Prospective, Multi-Center Investigation of the da Vinci SP Surgical System in Colorectal Procedures for Benign and Malignant Disease, Evaluation of Applaud Medical's Acoustic Enhancer With Laser Lithotripsy System in the Treatment of Urinary Stones, The Safety and Effectiveness of DuraSorb for Reinforcement in Patients Undergoing Prosthetic Breast Reconstruction, Evaluation of the Safety and Efficacy of the Carag Bioresorbable Septal Occluder (CBSO) to Treat Patients With Clinically Significant Secundum Atrial Septal Defect, Combined Infusion System to Deliver Chemotherapy Regionally to the Liver, A Randomized, Open Label, Cross-over Feasibility Study for Heparin-free Hemodialysis With the Dialyzer With Endexo in End-Stage Renal Disease (ESRD) Subjects, A Pilot Protocol Evaluating Safety of the Medtronic Pump and Codman Catheter for the Delivery of Hepatic Arterial Infusion (HAI) Chemotherapy in Patients With Advanced Colorectal Carcinoma or Cholangiocarcinoma, Multicenter Randomized Assessment of the Firehawk Rapamycin TARGET Eluting Cobalt Chromium Coronary Stent System - North American Trial, Prospective, Open-Label, Multi-Center Single-Arm Trial Designed to Assess the Safety, Performance and Efficacy of the NeVa Stent Retriever in the Treatment of Large Vessel Occlusion Strokes, Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation, The DETOUR2 Continued Access Clinical Trial - The Detour Endovascular Technique for Long OcclUsive Fem-pop Revascularization - Continued Access Clinical Trial, IMPact on Revascularization Outcomes of intraVascular Ultrasound Guided Treatment of Complex Lesions and Economic Impact (IMPROVE), Early Feasibility Study for the Foldax Tria Aortic Heart Valve, Esophagus Deviation and Radiofrequency Ablation of Atrial Fibrillation - EASY AF STUDY, A Study to Evaluate the Corvia Medical, Inc. IASD System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure.

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