These modules provide industry with information that is comprehensive, interactive, and easily accessible. Assistant Director for Committee Management and Planning. (vii) Pharmacy's name, address, DEA registration number, and prescription number from which the prescription was originally filled. 827), the prescribing practitioner, and the practitioner administering the controlled substance, as applicable, shall maintain complete and accurate records of all controlled substances delivered, received, administered, or otherwise disposed of, under this paragraph (f), including the persons to whom the controlled substances were delivered and such other information as may be required under this chapter. (b) If the prescription is filled at a central fill pharmacy, the central fill pharmacy shall affix to the package a label showing the retail pharmacy name and address and a unique identifier, (i.e. 10903 New Hampshire Avenue CDR Daniel Bailey. Final Guidances on "Deciding When to Submit a 510(k) for a Change to an Existing Device" and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device"PresentationPrintable SlidesTranscript, 510(k) Format Guidance, Including Standards Form, and Extensions/Clinical Trial Form and 510(k)PresentationPrintable Slides, De Novo Final Rule: Overview and Guidance UpdatesPresentationPrintable Slides Transcript, De Novo ProgramPresentation Printable SlidesTranscript, Clinical Studies/Investigational Device Exemption (IDE), IDE BasicsPresentationPrintable Slides Transcript, Implementation of Final Rule on Human Subject Protection: Acceptance of Data from Clinical Investigations for Medical DevicesPrintable Slides Survey, Final Guidance on Adaptive Designs for Medical Device Clinical StudiesPresentation Printable Slides Transcript, An Update on the FDA's Medical Device Clinical Trials ProgramPresentation Printable Slides (Full, Part 1, Part 2) Transcript, Breakthrough Devices ProgramPresentation Printable Slides Transcript, Strengthening the Medical Device Clinical Trial EnterprisePresentationPrintable SlidesTranscript, IDEs for Early Feasibility Medical Device Clinical Studies, Including First in Human (FIH) StudiesPresentationPrintable SlidesTranscript, FDA Guidance: Design Considerations for Pivotal Clinical Investigations for Medical DevicesPresentationPrintable SlidesTranscript, Final Guidance on "Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies"PresentationPrintable SlidesTranscript, Evaluation of Sex-Specific Data in Medical Device Clinical StudiesPresentationPrintable SlidesTranscript, FDA Decisions for Investigational Device Exemption (IDE) Clinical InvestigationsPresentationPrintable SlidesTranscript, Clinical Studies/IDEPresentation Printable Slides Transcript, Post-Approval Study Requirements and Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act, Final Guidances (Updated 12/15/22)Presentation Printable Slides Transcript, Postmarket Surveillance under 522 Section of the Food, Drugs and Cosmetic (FD&C) ActPresentationPrintable SlidesTranscript, FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage DecisionsPresentationPrintable SlidesTranscript, Introduction to the Premarket Approval Application (PMA) ProgramPresentation Printable Slides Transcript, Premarket Approval Application (PMA) Program: Postapproval RequirementsPresentation Printable Slides Transcript, Humanitarian Use Device (HUD)/Humanitarian Device Exemption (HDE), Module 1: Office of Orphan Products DevelopmentPresentationPrintable SlidesTranscript, Module 2: Humanitarian Use Device (HUD): Program OverviewPresentationPrintable SlidesTranscript, Module 3: Humanitarian Device Exemption (HDE): Program Overview and Pre-approval ActivitiesPresentationPrintable SlidesTranscript, Module 4: Humanitarian Device Exemption (HDE): Post-approval ActivitiesPresentationPrintable SlidesTranscript, Humanitarian Device Exemption ProgramPresentation Printable Slides Transcript, Q-Submission Program for Medical Device SubmissionsPresentationPrintable Slides Transcript, Requests for Feedback: The Pre-Submission Program and Meetings with FDA StaffPresentationPrintable SlidesTranscript, Module 1: Standards OverviewPresentationPrintable SlidesTranscript, Module 2: Standards Resources and Premarket UsePresentationPrintable SlidesTranscript, Module 3: CDRH Standards Recognition ProcessPresentationPrintable SlidesTranscript, Module 4: How to Use Consensus Standards in Premarket SubmissionsPresentation Printable Slides Transcript, Module 5: The ASCA Pilot: Streamlining Conformity Assessment in Device SubmissionsPresentation Printable Slides Transcript, Webinar - ASCA Pilot: Streamlining Conformity Assessment in Device SubmissionsPresentation Printable Slides TranscriptTAKE OUR SURVEY - Tell us what you think about the webinar, Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final GuidancesPresentationPrintable Slides Transcript, Appropriate Use of Voluntary Consensus StandardsPresentation Printable Slides Transcript, Recognition and Withdrawal of Voluntary Consensus Standards - Final GuidancePresentation Printable Slides Transcript, Safer Technologies Program: Draft GuidancePrintable SlidesTAKE OUR SURVEY - Tell us what you think about the webinar, Combination Product Updates for "Acceptance and Filing Reviews for Premarket Approval Applications" and "Refuse to Accept Policy for 510(k)s"PresentationPrintable SlidesTranscript, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical DevicesPresentationPrintable SlidesTranscript, Patient PreferenceInformationPresentationPrintable SlidesTranscript, Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical DevicesPresentationPrintable SlidesTranscript, How to Create and Submit an eCopyPresentation, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo ClassificationsPresentationPrintable SlidesTranscript, CDRH Final Guidance: Qualification of Medical Device Development ToolsPresentationPrintable SlidesTranscript, The Least Burdensome Provisions: Concept and Principles Final GuidancePresentation Printable Slides Transcript, Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device ExemptionsPresentation Printable Slides Transcript, Multiple Function Device Products: Policy and ConsiderationsPresentation Printable Slides Transcript, How is My Medical Device Classified?Presentation Printable Slides Transcript, Case Study: How is My Medical Device Classified?Presentation Printable Slides Transcript, 513(g) Requests for InformationPresentation Printable Slides Transcript, Final Guidance on Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory TypesPresentationPrintable SlidesTranscript, BIMO Part 1 - Introduction to the Bioresearch Monitoring ProgramPresentationPrintable Slides, BIMO Part 2 - Computerized Systems Used in Medical Device Clinical InvestigationsPresentationPrintable Slides, BIMO Part 3a - Institutional Review Board: Responsibilities in Making the Significant Risk and Non-significant Risk Device DeterminationPresentationPrintable Slides, BIMO Part 3b - Institutional Review Board: Humanitarian Use Devices (HUDs)PresentationPrintable Slides, BIMO Part 3c - Institutional Review Board: Compassionate and Emergency UsePresentationPrintable Slides, BIMO Part 4a - Preparing for an FDA Medical Device Sponsor InspectionPresentationPrintable Slides, BIMO Part 4b - Preparing for an FDA Clinical Investigator InspectionPresentationPrintable Slides, BIMO Part 4c - Preparing for an FDA Institutional Review Board InspectionPresentationPrintable Slides, BIMO Part 5a - Strategies for Sponsors to Build Quality into Device ResearchPresentationPrintable Slides, BIMO Part 5b - Strategies For Clinical Investigators to Build Quality into Device ResearchPresentationPrintable Slides, Preparing for a Clinical Investigator InspectionPresentationTranscript, Start Here! The FDA is currently developing draft guidance for public comment to help industry and FDA staff understand how the 21st Century Cures Act affects FDA's oversight of medical device software. Rather, individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so. To make corrections, see the HHS directory contact list. Dictionary: CDRH 2016-2017 Strategic Priority: Promote a Culture of Quality and Organizational Excellence Goal: Strengthen FDA's Culture of Quality within the Center for Devices and Radiological Health. WO32-5245 If such an application provides a hard-copy printout of each day's controlled substance prescription order refill data, that printout shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order. 10903 New Hampshire Avenue (b) A prescription for a Schedule III, IV, or V narcotic drug approved by FDA specifically for "detoxification treatment" or "maintenance treatment" must include the identification number issued by the Administrator under 1301.28(d) of this chapter or a written notice stating that the practitioner is acting under the good faith exception of 1301.28(e) of this chapter. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 51 FR 5320, Feb. 13, 1986; 62 FR 13965, Mar. (b) A pharmacy may fill an electronically transmitted prescription for a controlled substance provided the pharmacy complies with all other requirements for filling controlled substance prescriptions in this part and with the requirements of part 1311 of this chapter. Not more than one day's medication may be administered to the person or for the person's use at one time. 301-443-5807. 31, 2010]. | Note: For HHS OIG personnel inquiries, please proceed to https://oig.hhs.gov/ 31, 2010]. (g) An individual practitioner exempted from registration under 1301.22(c) of this chapter shall include on all prescriptions issued by him the registration number of the hospital or other institution and the special internal code number assigned to him by the hospital or other institution as provided in 1301.22(c) of this chapter, in lieu of the registration number of the practitioner required by this section. However, pharmacies electronically sharing a real-time, online database may transfer up to the maximum refills permitted by law and the prescriber's authorization. Sec. (2) Keep a record of the date of receipt of the transmitted prescription, the name of the licensed pharmacist filling the prescription, and dates of filling or refilling of the prescription; Authority: 21 U.S.C. 16071 Industrial Drive, HFZ-260. Unique Device Identification: Convenience Kits, Final GuidancePresentation Printable Slides Transcript, COVID-19 Transition Policy - (Updated module 04/27/23), COVID-19 Transition Policy for Devices, Final Guidances - Updated 04/27/23Presentation Printable Slides Transcript, Dental Devices Premarket SubmissionsPresentation Printable Slides Transcript, Final Guidance on "General Wellness: Policy for Low-Risk Devices". Welcome to CDRH Learn! For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. (g) Central fill pharmacies may not dispense controlled substances to a purchaser at retail pursuant to this section. (5) In the event that a pharmacy which employs such a computerized application experiences system down-time, the pharmacy must have an auxiliary procedure which will be used for documentation of refills of Schedule III and IV controlled substance prescription orders. (a) Prescriptions for controlled substances listed in Schedule III, IV or V may be transmitted electronically from a retail pharmacy to a central fill pharmacy including via facsimile. 1306.22 Refilling of prescriptions. Organizational Development Team, An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Office of Science and Engineering Laboratories, Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health, CDRH Management Directory by Organization, Associate Director for Scientific and Regulatory Programs, Associate Director for International Affairs, Associate Director for TPLC Advisory Program (TAP), Associate Director for Strategic Communications, Assistant Director for Quality Management Systems, Assistant Director for Process Improvement, Associate Director for Operations and Quality Management, Branch Chief for Technology and Learning Management, Branch Chief for Postmarket and Consumer Programs, Branch Chief for Freedom of InformationA, Branch Chief for Freedom of Information B, Deputy Officer Director and Deputy Executive Officer, Director for Management Systems and Analysis, Assistant Director for Inclusion and Wellness Strategy, Assistant Director for Advanced Acquisitions, Assistant Director for Simplified Acquisitions/Planning and Assistance, Assistant Director forTravel and Conference Management, Assistant Director for Space and Facilities Management, Assistant Director forCommittee Management and Planning, Assistant Director for Human Capital Management, Assistant Directorfor Budget Formulation, Assistant Director forFinancial Accountability, Associate Director for Guidance, Legislation and Special Projects, Associate Director for Regulatory Documents and Special Projects, Associate Director for Total Product Life Cycle Review Program Innovation, Associate Director andChief Medical Science Officer, Supervisor for Clinical and Scientific Policy Staff 1, Supervisor for Clinical and Scientific Policy Staff 2, Associate Director for Professional Development, Assistant Director for 510(k), DeNovo, 513(g), Device Determinations and Custom Devices Lifecycle, Assistant Director for PMA, HDE, Pre-submission and Device Tracking Lifecycle, Assistant Director for Imports and Registration and Listing, Assistant Director for FDA Inspections and Regulatory Audits, Assistant Director for Recalls and Shortages, Assistant Director for Regulatory Systems Management, Assistant Director for Tools and Templates, Assistant Director for Review Performance Analytics, Assistant Director for Market Intelligence Analytics, Assistant Director for Policy and Operations 1, Assistant Director for Policy and Operations 2, Assistant Director for Clinical Evidence Quality 1, Assistant Director for Clinical Evidence Quality 2, Assistant Director for Clinical Evidence Outcomes Research 1, Assistant Director for Clinical Evidence Outcomes Research 2, Assistant Director for Outreach and Partnerships, Assistant Director for Intraocular Lens and Accessory Devices, Assistant Director for Contact Lenses and Dry Eye Devices, Assistant Director for Retinal and Diagnostic Devices, Assistant Director for Glaucoma, Cornea, and Surgical Devices, Assistant Director for Implantable Dental Devices, Assistant Director for Restorative and Surgical Dental Devices, Assistant Director for Anesthesia Devices, Assistant Director for Respiratory Devices, Assistant Director for Sleep Disordered Breathing Devices, Associate Director Professional Development, Assistant Director for Blood Pressure and Flow Devices, Assistant Director for Cardiac Ablation, Mapping, and Imaging Devices, Assistant Director for External Heart Rhythm and Rate Devices, Assistant Director for Implantable Electrophysiology Devices, Assistant Director for Cardiac Occluders and Hemostasis Devices, Assistant Director for Circulatory Support Devices, Assistant Director for Heart Valve Devices, Assistant Director for Vascular and Endovascular Devices, Assistant Director for Coronary Interventional Devices, Assistant Director for Peripheral Interventional Devices, Assistant Director for Plaque Modification Devices, Assistant Director forRenal and Transplantation Devices, Assistant Director for Gastroenterology and Endoscopy Devices, Assistant Director for Obesity and Hepatobiliary Devices, Assistant Director for Obstetrical and Reproductive Health Devices, Assistant Director for Gynecological and Surgical Devices, Assistant Director for Urological Devices, Assistant Director for Incontinence and Female Urological Devices, Assistant Director for General Hospital Devices, Assistant Director for Human Factors and Reliability Engineering, Assistant Director for Robotic Assisted Surgery Devices, Assistant Director for Non-Light Based Energy Devices, Assistant Director for Light Based Energy Devices, Assistant Director for Cancer Diagnosis and Treatment Devices, Assistant Director for Personal Protective Equipment, Reprocessing and Disinfection Devices, Assistant Director for Plastic Surgery Implant Devices, Assistant Director for Plastic Surgery Skin and Wound Devices, Assistant Director for Disinfection and Reprocessing Devices, Assistant Director for Neurosurgical Devices, Assistant Director for Neurointerventional Devices, Assistant Director for Neurodiagnostic Devices, Assistant Director for Neurostimulation-Neurology Devices, Assistant Director for Neuromodulation-Psychiatry Devices, Assistant Director for Acute Injury Devices, Assistant Director for Neurodegenerative Devices, Assistant Director for Knee Arthroplasty Devices, Assistant Director for Hip Arthroplasty Devices, Assistant Director for Shoulder Arthroplasty Devices, Assistant Director for IntervertebralSpinal Fusion Devices, Assistant Director for Longitudinal Spinal Fusion Devices, Assistant Director for Restorative, Repair, Trauma and Fracture Fixation Devices, Assistant Director for Stereotaxic, Bone Growth Simulators and Fracture Fixation Device, Associate Director for Strategic Initiatives, Associate Director for Regulatory Programs, Chief Medical Officer and Associate Director for Medical Affairs, Assistant Director for Laboratory Improvements, Outreach and Analysis, Branch Chief for Cardio-Renal Diagnostics, Branch Chief for Immunology and Flow Cytometry, Branch Chief for Molecular Pathology and Cytology, Deputy Branch Chief for Molecular Pathology and Cytology, Deputy Branch Chief for Molecular Genetics, Branch Chief for Viral Respiratory and HPV, Deputy Branch Chief for Viral Respiratory and HPV, Branch Chief for General Viral and Hepatitis, Deputy Branch Chief for General Viral and Hepatitis, Branch Chief for General Bacterial and Antimicrobial Susceptibility, Deputy Branch Chief for General Bacterial and Antimicrobial Susceptibility, Branch Chief for Bacterial Respiratory and Medical Countermeasures, Deputy Branch Chief for Bacterial Respiratory and Medical Countermeasures, Chief Medical Officer for Radiological Health, Assistant Director for Program Management, Assistant Director for Information Management, Assistant Director for Diagnostic X-Ray Systems, Assistant Director for Electronic Products, Assistant Director for Mammography and Ultrasound, Assistant Director for Magnetic Resonance and Nuclear Medicine, Deputy OfficeDirector for Regulatory Engagement and Innovation, Associate Director for Strategic Initiative & Outreach, Assistant Director for Laboratory Support, Assistant Director for Financial and Resource Management, AssistantDirector for Chemical Characterization, Assistant Director for Sterility and Infection Control, Assistant Director for Electromagnetic and Electrical Safety, Assistant Director for Interoperable Patient Monitoring and Control Systems Team, Assistant Director for Orthopedics and Additive Manufacturing Team, Assistant Director for Software and High-Performance Computing, Assistant Director for Imaging PhysicsTeam, Associate Director for Resilient Supply Chain, Supervisor for Resilient Supply Chain Operations, Associate Director for Technology and Innovation, Associate Director for Digital Transformation, Chief Medical Officer for Health of Women, Chief Medical Officer for Pediatrics Special Populations, Assistant Director for All-hazards Readiness, Response Cybersecurity, Assistant Director for Patient Science and Engagement, Assistant Director for Partnerships to Advance InnovationRegulatory Science, Assistant Director for Standards and Conformity Assessment, Assistant Director for Digital Health Policy Leadership and Development, Assistant Director for Emerging Digital Health Technology Assessment and Strategy, Supervisor for Digital Health Center ofExcellence, Assistant Director for Business Transformation Services, Assistant Director for Technology Services.
How To Add Database In Intellij Community Edition,
Articles F
