Sponsors need not submit a PMA or Premarket Notification 510(k), register their establishment, or list the device while the device is under investigation. About the Ozempic (semaglutide) shortage 2022 and 2023 additional records and reports (a description of any records or reports of the investigation other than those required in Subpart G of the IDE regulations). The Company Cover Letter of each submission should identify the submission type, for example, "Original IDE Application," "IDE Supplement," "IDE Report," etc. [25.34(g)], Copies of all informed consent forms and all related information materials to be provided to subjects as required by 21 CFR 50, Protection of Human Subjects. A submission that only responds to SDCs will be considered a request to modify the protocol and be tracked as a Supplement. 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? Manufacturing: Inadequate or missing description of the controls used to ensure that the devices are produced consistently and as designed. A Feasibility Study of Sequential Hepatic Internal Radiation and Systemic Ipilimumab and Nivolumab in Patients With Uveal Melanoma Metastatic to Liver. The majority of IDE studies are conducted to collect safety and or Impact of Fever Prevention in Brain Injured Patients, Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest (EROCA), Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction to Reduce Infarct Size (DTU): A Prospective Feasibility Study, Da Vinci SP Surgical System, Endowrist SP Instruments, and Accessories, Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH), Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia, IN.PACT AV Access Paclitaxel-Coated PTA Balloon Catheter, A Multi-Center, Randomized, Pivotal Study Evaluating AMPLEX Compared To Autogenous Bone Graft in Subjects Indicated for Arthrodesis Surgery Involving the Hindfoot or Ankle, Clinical Study of the BioVentrix Revivent TC System for Treatment of Left Ventricular Aneurysms, LEADERS FREE II: BioFreedom Pivotal Study. Design: Inadequate characterization or description of the device and its operation due to inadequate or omitted: Description of materials (including biocompatibility information), Description of function - how does device and/or components/subsystems work together to achieve desired function, Validation testing for subsystems and main system. e. installation, Environmental Impact Assessment: [812.20(b)(9)], An environmental impact assessment or a claim for categorical exclusion is no longer required. A Prospective Global Randomized Trial Assessing the Safety and Efficacy of the BuMA Supreme Biodegradable Drug Coated Coronary Stent System for Coronary Revascularization in Patients With Stable Coronary Artery Disease or Non-ST Segment Elevation Acute A Prospective, Multicenter, Non-Blinded, Non-Randomized Early Feasibility Study of the Relay Branch Thoracic Stent-Graft System in Subjects With Thoracic Aortic Pathologies Requiring Treatment Proximal to the Origin of the Innominate Artery, The OPTIMIZE Trial to Assess the Procedural and Clinical Value of the Svelte IDS and RX Sirolimus Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions in a Randomized Study, An Open Label, Single Arm Pilot Study of OncoSil, Administered to Subjects With Unresectable Locally Advanced Pancreatic Adenocarcinoma, Given in Combination With Gemcitabine or Gemcitabine+Nab-paclitaxel Chemotherapies, Prospective, Randomized, Double-Blinded, Controlled Multi-Center Clinical Trial Evaluating the Use of Non-Invasive CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures, A Multi-center, Randomized, Within-subject-controlled, Open Label Study of the Safety and Effectiveness of VEST, Venous External Support, Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Cardiva Mid-Bore Venous Vascular Closure System (VVCS), Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST - MST), Evaluation of the Surfacer System Approach to Central Venous Access, Multicenter Early Feasibility Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 Transcather Heart Valve With the Alterra Adaptive Prestent, Haploidentical CD34+ Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant for Treatment of High-risk Hematologic Disorders, Medtronic TAAA Debranching Stent Graft System, Cardiogenic Shock Intravascular Cooling Trial (CHILL-SHOCK), Operative Procedures vs. Endovascular Neurosurgery for Untreated Pseudotumor Trial (OPEN-UP), Deep Brain Stimulation to Relieve Depression, RELIEF Study: A Prospective, Multicenter Study of REflux Management With the LINX System for Gastroesophageal REFlux Disease After Laparoscopic Sleeve Gastrectomy, Assessment of the Carillon Mitral Contour System in Treating Functional Mitral Regurgitation Associated With Heart Failure, STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation, Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II, Endograft Repair of Thoracoabdominal Aortic Aneurysms (TAAA), Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial, A Prospective, Randomized, Multi-Center, Open-Label Pilot Study of Infuse Bone Graft With Mastergraft Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions, Corvia Medical Interatrial Shunt Device (IASD) System II, Revolution Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization, TECNIS Next-Generation Intraocular Lens, Models ZHR00 and ZQR00, Clinical Evaluation of the Cochlear Nucleus(R) CI532 Cochlear Implant in Adults, Phase III Study to Compare the Effectiveness of Magnetic Resonance Guided Focused Ultrasound With Computed Tomography Guided Radiofrequency Ablation for Treatment of Osteoid Osteomas, Healing Chronic Venous Stasis Wounds With Autologous Cell Therapy. Evaluation of Spinal Cord Ischemia and Mortality and Morbidity After Endovascular Repair of Pararenal and Thoracoabdominal Aortic Aneurysm Using Surgeon-Modified Endografts, Clinical Investigation of the TECNIS Next-Generation Intraocular Lens, Model DEN00V, Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial, Evaluation of the GORE VIAFORT Vascular Stent for Treatment of Symptomatic Inferior Vena Cava Obstruction With or Without Combined Iliofemoral Obstruction, Comparison of Left Bundle Branch Area Versus Right Ventricular Septal Pacing in Patients With High-degree Conduction Disease After Transcatheter Aortic Valve Replacement, A Phase II Trial of CD34+ Enriched Transplants From HLA-Compatible Related or Unrelated Donors for Treatment of Patients With Leukemia or Lymphoma, A Feasibility Study of the NEURESCUE Device as an Adjunct to In-Hospital Cardiac Arrest, Treatment of Ruptured Wide-Neck Aneurysms with Nautilus Device Assisted Occlusion (TORNADO). Scoreflex NC - Scoring PTCA Catheter: A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Safety and Device Procedural Success of the Scoreflex NC Scoring PTCA Catheter in Subjects With Stenotic Coronary Arter Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR), Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens, Prospective, Multicenter, Single-Arm, Global IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2 Coronary IVL Catheter in Calcified Coronary Arteries, Prospective, Trial Evaluating the Safety and Effectiveness of the Interscope Endorotor System for Direct Endoscopic Necrosectomy of Walled Off Pancreatic Necrosis, Evaluation of the Cardio Flow FreedomFlow Orbital Circumferential Atherectomy System to Treat Peripheral Artery Disease, Noninvasive Biomarkers to Advance Emerging DBS Electrode Technologies in Parkinson's Disease, BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction, A Post-approval Study of the Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System, SYNergy Stent System Implantation With Mandatory Intra-VascularUltra-Sound Guidance to Examine the Safety of Cessation of Dual Anti-Platelet Therapy in High Bleeding Risk Patients at One Month, Pivotal Study of the LUM Imaging System for Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patients With Breast Cancer, Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility, Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study), The "RADIANCE II" Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Generic types of device and manufacturing changes include changes to the control mechanism, principle of operation, energy type, environmental specifications, performance specifications, ergonomics of patient-user interface, dimensional specifications, software or firmware, packaging or expiration dating, sterilization, and the manufacturing process (including the manufacturing site). You should review 42 U.S.C. The sponsor must provide notice to FDA within 5-working days of making these changes. 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. This determination is made by the sponsor and must be based on credible information. Emergency Use FDA approval o Inclusion of this information should help speed FDA's administrative processing of the application. The investigator must submit to the sponsor and the reviewing IRB a report of any unanticipated adverse device effect as soon as possible but no later than 10 working days after the investigator first learns of the effect. purpose (the name and intended use of the device and the objectives and duration of the investigation), protocol (a written protocol describing the methodology to be used and an analysis of the protocol demonstrating its scientific soundness), risk analysis (a description and analysis of all increased risks to the research subjects and how these risks will be minimized; a justification for the investigation; and a description of the patient population including the number, age, sex, and condition), description of this device (a description of each important component, ingredient, property, and principle of operation of the device and any anticipated changes in the device during the investigation). b. processing Sponsors, IRBs, and investigators are required to permit authorized FDA employees reasonable access at reasonable times to inspect and copy all records of an investigation. A summary of the PBAC advice can be found on the PBS website. Before sharing sensitive information, make sure you're on a federal government site. SELUTION SLR 014 BTK: A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Effectiveness of the SELUTION SLR 014 Drug Eluting Balloon in the Treatment of Below-the-Knee (BTK) Atherosclerotic Disease in Patients With Chr A Prospective, Multi-Center Investigation of the da Vinci SP Surgical System in Pulmonary Lobectomy and Thymectomy for Benign and Malignant Disease, Pre-pectoral Tissue Expander to Implant Breast Reconstruction with and without Mesh Assistance: Multicenter Randomized Controlled Trial, RNS System Responsive Thalamic Stimulation for Primary Generalized Seizures (NAUTILUS) Study, A Feasibility Evaluation of the Muse Magnetic Resonance Guided Focused Ultrasound System, A Prospective Multicenter Study of Transbronchial Microwave Ablation Using Robotic Assisted Bronchoscopy in Subjects with Oligometastatic Tumors in the Lung, Early Feasibility Clinical Study of the Nervive VitalFlow Stimulation System for Treatment of Acute Ischemic Stroke Patients, Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial, The Revitalize Trial: Reducing Vaginal Atrophy With Fractional CO2 Laser for Breast Cancer Survivors, Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism, Study on the Safety and Effectiveness of APrevent VOIS Implants for Treatment in Patients With Unilateral Vocal Fold Paralysis (UVFP) - a Two-Part, Open-Label, Non-Randomized Multicenter Study, Use of the Impella ECP in Patients Undergoing an Elective or Urgent High-Risk Percutaneous Coronary Intervention, Clinical Investigation of the Safety and Effectiveness of FINEVISION HP Trifocal IOL, Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia, Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System (AdmIRE), A Prospective, Randomized, Controlled, Interventional Clinical Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical MonoPoint Reperfusion System for Aspiration Embolectomy in Acute Ischemic Stroke Patients (SUMMIT MAX), Stage 2B of: A Pivotal, Prospective, Three-Stage, Single-Arm Study of Focal Ablation of the Prostate With NanoTherm Therapy System for a Limited-Volume, Clinically Localized, Intermediate-Risk Prostate Cancer, Prospective, Multi-center, Randomized Trial of the Protect PNS for Refractory Overactive Bladder (OAB) GUARDIAN Study, A Randomized Cross-Over Trial of Deep Brain Stimulation (DBS) of the Posterior Subthalamic Area (PSA), Ventral Intermediate Nucleus of the Thalamus (VIM), and VIM+PSA on Essential Tremor (ET), The SEAL TO HEAL Study: Study to EvALuate Time TO HEmostasis of AbsorbaSeaL, A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating Bilateral-Subthalamic Nucleus Deep Brain Stimulation in Subjects with Early Stage Parkinsons Disease, Use of the Impella ECP in Patients Undergoing an Elective High-Risk Percutaneous Coronary Intervention: An Early Feasibility Study, A Prospective, Multi-Center, Open-Label Assessment of Efficacy and Safety of Quanta SC+ for Home Hemodialysis, Early Feasibility Study of the Vivasure PerQseal+ (PerQseal Plus) Vascular Closure Device when used to Achieve Hemostasis of Common Femoral Arteriotomies Created by 14 to 22 F Sheaths in Patients Undergoing Percutaneous Transcatheter Procedures, Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) - FASTR Trial, Bariatric Embolization of Arteries With Imaging Visible Embolics, A ProspEctive, Single ARm, Multi-center Clinical InveStigation to EValuatE the Safety and Effectiveness of AMDS in the TREatment of Acute DeBakey Type I Dissection: PERSEVERE, Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever, Prospective Multicenter MANTA Vascular Closure Device Ultrasound Guided Closure Study, Mepitel Film for the Reduction of Radiation Dermatitis in Breast Cancer Patients Undergoing Post-Mastectomy Radiation Therapy: A Randomized Phase III Clinical Trial, Flow Regulation by Opening the SepTum in Patients With Heart Failure; a Prospective, Randomized, Sham-controlled, Double-blind, Global Multicenter Study, Assessment of Implantable CCM in the Heart Failure Group With Higher Ejection Fraction, Treatment of Persistent Atrial Fibrillation With the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System, A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon (EXPANSE-PTCA), A Prospective, Multicenter, Pivotal Study With Randomized Controlled Prophylactic and Independent Therapeutic Cohorts to Evaluate the Safety and Efficacy of an Absorbable Vena Cava Filter for Pulmonary Embolism Prevention, Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions, Epidural Prefrontal Cortical Stimulation (EpCS) in Severe Treatment Resistant Depression, SEAM Trial: Sutureless End to End Anastomosis by Magnetic Compression: A Study to Evaluate Safety and Effectiveness of Self-Forming Magnet (SFM) Anastomosis Device: A Historically Controlled Propensity Matched Study, A Multicenter, Prospective, Open-label, Randomized Controlled Clinical Trial to Compare the Safety and Effectiveness of the VitaSmart Liver Machine Perfusion System With Static Cold Storage for Organ Preservation Prior to Liver Transplantation, The Cardiac Pulmonary Nerve Stimulation (CPNS) Pilot Study, Dorsal Root Ganglion Stimulation Outcomes for the Treatment of Mechanical Knee Pain Among Patients With Osteoarthritis of the Surgical and Non-surgical Knee, ACCEL Absorbable Hemostat Powder Clinical Trial, Advanced Impella SmartAssist System for Patient Monitoring & Treatment: An Early Feasibility Study, A Prospective, Multicenter, Single-arm Investigation of the Ringer Perfusion Balloon Catheter Performed Under an Exception From Informed Consent (EFIC) (Ringer IDE Study), Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II, An Early Feasibility Study Assessing the Safety, Technical Performance, and Efficacy of the Electrolytic eCLIPs Bifurcation System for the Treatment of Intracranial Bifurcation Aneurysms. 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. 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. If another method of assessment was used, the notice must include a summary of the information which served as the credible information supporting the change. Data from beginning of the study should be reported, unless otherwise indicated. A suggested format is provided below. The investigator must submit progress reports to the sponsor, the monitor, and the reviewing IRB at regular intervals but no less than on a yearly basis. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. A sponsor cannot begin a significant risk device investigation until FDA and IRB approval are granted. 5-day Notice: The sponsor must submit a notice of the change to the IDE no later than 5-working days after making the change. [ 812.5(a))], Note: The device may not be promoted as safe and effective for the use for which it is being investigated. 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. All changes to the basic principles of operation of a device are considered to be significant changes that should be submitted in an IDE supplement. How many IRBs have approved the investigation? In this case, the reporting requirement would not have been met and a separate report would be required. Final Report: The investigator must submit a final report to the sponsor and to the reviewing IRB within 3 months after termination or completion of the investigation. ), 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. 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. For a protocol change, the notice must include a description of the change (cross-referenced to the appropriate sections of the original protocol); an assessment supporting the conclusion that the change does not have a significant impact on the study design or planned statistical analysis; and a summary of the information that served as the credible information supporting the sponsor's determination that the change does not affect the rights, safety, or welfare of the subjects. 812.7(b) prohibits the commercialization of an investigational device by charging subjects or investigators for a device a price larger than necessary to recover costs of manufacture, research, development, and handling. Share sensitive information only on official, secure websites. These notices must be identified as a "notice of IDE change.". Sign up to get the latest information about your choice of CMS topics. The site is secure. IDE Records | FDA - U.S. Food and Drug Administration [812.7(d)], Informed Consent Materials: [21 CFR 50, 812.25(g)]. A Multicenter, Prospective, Randomized, Clinical Trial Comparing the Safety and Effectiveness of the BAGUERAC Cervical Disc Prosthesis to the Mobi-C Cervical Disc for the Treatment of Patients With Symptomatic Cervical Disc Disease at Two Contiguous L Randomized Clinical Evaluation of the AccuCinch Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study, Functional Electrical Stimulation of the Bilaterally Paralyzed Human Larynx, A Multicenter Study to Assess the Safety and Effectiveness of the Genio Dual-sided Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnea in Adults Subjects, Genicular Artery Embolization for the Treatment of Moderate to Severe Osteoarthritic Knee Pain, A Multicenter, Prospective, Randomized, Clinical Trial Comparing the Safety and Effectiveness of the BAGUERAC Cervical Disc Prosthesis to the Mobi-C Cervical Disc for the Treatment of Patients With Symptomatic Cervical Disc Disease at a Single Level, Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System, A Multi-arm, Multi-Center, Non-Randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUS Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch, The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM), Prospective Pilot Study of Robot-Assisted Nipple Sparing Mastectomy (RNSM), Physiologic Accelerated Pacing as a Treatment in Patients With Heart Failure With Preserved Ejection Fraction, Safety and Effectiveness Evaluation of Boston Scientific's Single Shot LUMINIZE RF Balloon Catheter in the Treatment of Symptomatic, Drug Refractory Paroxysmal Atrial Fibrillation, Randomized Prospective Trial of Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer.