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学校获得的好处似乎显而易见:它们有了优秀的毕业生任教,否则这些学生将会直接进入咨询行业。
此外,由于该机构的一些业务涉及为政府提供教育方面的建议,此类员工的专长是很宝贵的。
技术在法律界并不是一个新现象——许多律所已经与人工智能和机器学习企业建立了合作伙伴关系,有些律所还建立了自己的“孵化器”,或者投资了法律科技初创公司。但这一趋势已经达到临界水平,并将在2018年急剧加速。
大力优化外商投资环境。
《中国文化遗迹》杂志是一本新创立的期刊,专门把发表在《文物》杂志上的原创文章翻译成英文。其创刊号上就发表了这座1700年墓地的发现。
The Family Hub has three internal cameras that connect to your phone to help you see what you do and don't have inside the fridge. So it's basically a $6,000 alternative to classic grocery list written on paper with a pencil.
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美联储上个月公布了今年放缓购债步伐的时间表。美联储计划在每一次政策会议上将购债规模减少100亿美元,直到今年年底不再进行购债。自从2012年末以来,美联储每个月都买入850亿美元美国国债和住房抵押贷款支持证券。
布莱恩·肯德罗拉是纽约Stack's Bowers Galleries 拍卖行的行长,他透露这次拍卖吸引了来自6个国家的6名竞拍者。在星期四举行的拍卖会上,中标者是一名匿名的亚洲收藏家。
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MDUFA Small Business Program, Registration and Listing

An Introduction to FDA's Regulation of Medical Devices
Presentation   Printable Slides   Transcript

How is CDRH Structured?
Presentation   Printable Slides   Transcript

Is My Product a Medical Device?
Presentation   Printable Slides   Transcript

Medical Device User Fee Amendments of 2017 (MDUFA IV): An Introduction
Presentation   Printable Slides   Transcript


MDUFA Small Business Program

Suggested tip before you watch this module:  Gather the materials you'll need to prepare Form FDA 3602 or Form FDA 3602A.  They are identified under the Device Advice section: "二线楼市疯狂:2小时卖完866套房 买到如同中彩票".

How to Complete Form FDA 3602: MDUFA Small Business Qualification and Certification for a Business Headquartered in the United States
Presentation   Transcript

How to Complete Form FDA 3602A: MDUFA Foreign Small Business Certification Request For a Business Headquartered Outside the United States
Presentation   Transcript


Registration and Listing

Regulatory Overview of Device Establishment Registration and Listing
Presentation   Printable Slides

Paying the Annual Registration User Fee via the Device Facility User Fee (DFUF) Website
Presentation   Printable Slides

FURLS Device Registration and Listing Module for Annual Registration
Presentation

FURLS Device Registration and Listing Module for Initial Registration
Presentation

510k, De Novo, IDE, PMA, HUD/HDE, Q-Submissions, Standards, Classification

Premarket Notification (510k)

The 510(k) Program
Presentation   Printable Slides   Transcript

The Special 510(k) Program: Final Guidance
Presentation   Printable Slides   Transcript

Special 510(k) Program Pilot
Presentation   Printable Slides   Transcript

Safety and Performance Based Pathway Criteria for Certain Device Types Final Guidances (New module 9/24/20)
Presentation   Printable Slides   Transcript
TAKE OUR SURVEY - Tell us what you think about the webinar

Safety and Performance Based Pathway Performance Criteria
Presentation   Printable Slides   Transcript

Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics
Presentation   Printable Slides   Transcript

Quality in 510(k) Review Program Pilot 
Presentation   Printable Slides   Transcript

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" 
Presentation   Printable Slides   Transcript

510(k) Format Guidance, Including Standards Form, and Extensions/Clinical Trial Form and 510(k)
Presentation   Printable Slides

510(k) Electronic Submission Pilot Program
Printable Slides   Transcript


De Novo

De Novo Program
Presentation   Printable Slides   Transcript

Acceptance Review for De Novo Classification Requests
Presentation  Printable Slides    Transcript     Survey

De Novo Classification Process (Evaluation of Automatic Class III Designation)
Presentation   Printable Slides   Transcript


中国央行调查:近半居民预期下季度房价“基本不变”

IDE Basics
Presentation   Printable Slides   Transcript

Implementation of Final Rule on Human Subject Protection: Acceptance of Data from Clinical Investigations for Medical Devices
Printable Slides    Survey

Final Guidance on Adaptive Designs for Medical Device Clinical Studies
Presentation   Printable Slides   Transcript

An Update on the FDA's Medical Device Clinical Trials Program
Presentation    Printable Slides (Full, Part 1, Part 2)    Transcript

Breakthrough Devices Program
Presentation   Printable Slides   Transcript

Early Feasibility Study (EFS) Program
Presentation

Strengthening the Medical Device Clinical Trial Enterprise
Presentation   Printable Slides   Transcript

IDEs for Early Feasibility Medical Device Clinical Studies, Including First in Human (FIH) Studies
Presentation   Printable Slides   Transcript

FDA Guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices
Presentation   Printable Slides   Transcript

Final Guidance on "Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies"
Presentation   Printable Slides   Transcript

Evaluation of Sex-Specific Data in Medical Device Clinical Studies
Presentation   Printable Slides   Transcript

FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
Presentation   Printable Slides   Transcript

Clinical Studies/IDE  
Presentation   Printable Slides   Transcript

Postmarket Surveillance under 522 Section of the Food, Drugs and Cosmetic (FD&C) Act
Presentation   Printable Slides   Transcript

FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions
Presentation   Printable Slides   Transcript


微利时代下2017年中国家居建材业如何迎接挑战?

Introduction to the Premarket Approval Application (PMA) Program
Presentation   Printable Slides   Transcript

Premarket Approval Application (PMA) Program: Postapproval Requirements
Presentation   Printable Slides   Transcript


The June announcement of collaboration between Google and fashion designer Diane von Furstenberg to create a new line of Google Glass underscored Silicon Valley’s current strategy to enlist the fashion elite to sanction wearables as de rigueur.

Module 1: Office of Orphan Products Development
Presentation   Printable Slides   Transcript

Module 2: Humanitarian Use Device (HUD): Program Overview
Presentation   Printable Slides   Transcript

Module 3: Humanitarian Device Exemption (HDE): Program Overview and Pre-approval Activities
Presentation   Printable Slides   Transcript

Module 4: Humanitarian Device Exemption (HDE): Post-approval Activities
Presentation   Printable Slides   Transcript

Humanitarian Device Exemption Program
Presentation   Printable Slides   Transcript


Q-Submissions

Q-Submission Program for Medical Device Submissions
Presentation   Printable Slides   Transcript

Requests for Feedback: The Pre-Submission Program and Meetings with FDA Staff
Presentation   Printable Slides   Transcript


Standards 

Module 1: Standards Overview
Presentation   Printable Slides   Transcript

Module 2: Standards Resources and Premarket Use
Presentation   Printable Slides   Transcript

Module 3: CDRH Standards Recognition Process
Presentation   Printable Slides   Transcript

Appropriate Use of Voluntary Consensus Standards
Presentation   Printable Slides   Transcript

Recognition and Withdrawal of Voluntary Consensus Standards - Final Guidance (New module - 10/15/20)
Presentation   Printable Slides   Transcript
TAKE OUR SURVEY - Tell us what you think about the webinar

Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidances (New module - 10/22/20)
Presentation   Printable Slides   Transcript


Cross-Cutting Premarket Policy

Safer Technologies Program: Draft Guidance
Presentation   Printable Slides   Transcript

Combination Product Updates for "Acceptance and Filing Reviews for Premarket Approval Applications" and "Refuse to Accept Policy for 510(k)s" 
Presentation   Printable Slides   Transcript

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
Presentation   Printable Slides   Transcript

Patient Preference Information 
Presentation   Printable Slides   Transcript

Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices
Presentation   Printable Slides   Transcript

How to Create and Submit an eCopy
Presentation

Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications
Presentation   Printable Slides   Transcript

CDRH Final Guidance: Qualification of Medical Device Development Tools
Presentation   Printable Slides   Transcript

The Least Burdensome Provisions: Concept and Principles Final Guidance
Presentation   Printable Slides   Transcript

Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions
Presentation   Printable Slides   Transcript

Multiple Function Device Products: Policy and Considerations (New module 9/10/20)
TAKE OUR SURVEY - Tell us what you think about the webinar
Presentation   Printable Slides   Transcript


Classification

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 Information
Presentation   Printable Slides   Transcript

Final Guidance on Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types 
Presentation   Printable Slides   Transcript


Bioresearch Monitoring (BIMO)

BIMO Part 1a - Good Clinical Practice 101: An Introduction
Presentation   Printable Slides

BIMO Part 1b - Introduction to the Bioresearch Monitoring Program
Presentation   Printable Slides

BIMO Part 2a - The Sponsor: Responsibilities in Medical Device Clinical Trials
Presentation   Printable Slides

BIMO Part 2b - The Clinical Investigator: Responsibilities in Medical Device Trials
Presentation   Printable Slides

BIMO Part 2c - Computerized Systems Used in Medical Device Clinical Investigations
Presentation   Printable Slides

BIMO Part 3a - Institutional Review Board: Responsibilities in Making the Significant Risk and Non-significant Risk Device Determination
Presentation   Printable Slides

BIMO Part 3b - Institutional Review Board: Humanitarian Use Devices (HUDs)
Presentation   Printable Slides

BIMO Part 3c - Institutional Review Board: Compassionate and Emergency Use
Presentation   Printable Slides

BIMO Part 4a - Preparing for an FDA Medical Device Sponsor Inspection
Presentation   Printable Slides

BIMO Part 4b - Preparing for an FDA Clinical Investigator Inspection
Presentation   Printable Slides

BIMO Part 4c - Preparing for an FDA Institutional Review Board Inspection
Presentation   Printable Slides

BIMO Part 5a - Strategies for Sponsors to Build Quality into Device Research
Presentation   Printable Slides

BIMO Part 5b - Strategies For Clinical Investigators to Build Quality into Device Research
Presentation   Printable Slides

Preparing for a Clinical Investigator Inspection
Presentation   Transcript

Quality System, Exporting, Device Recalls, MDR, Inspection - Global Harmonization

Overview of the Quality System

Start Here! Overview of the Quality System
Presentation   Printable Slides   Transcript

Production and Process Controls
Presentation   Printable Slides   Transcript

Production and Process Controls, Part 2
Presentation   Printable Slides   Transcript

Documents, Change Control, and Records
Presentation   Printable Slides   Transcript

Design Controls 
Presentation   Printable Slides   Transcript

Management Controls 
Presentation   Printable Slides   Transcript

Purchasing Controls
Presentation   Printable Slides   Transcript

Process Validation
Presentation   Printable Slides   Transcript

Corrective and Preventive Actions
Presentation   Printable Slides   Transcript

Nonconforming Product
Presentation   Printable Slides   Transcript

Complaint Files
Presentation   Printable Slides   Transcript


Exports and Imports

Exporting Medical Devices
Presentation   Printable Slides   Transcript

Importing Medical Devices Into the United States
Presentation   Printable Slides   Transcript


General Policy

Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency
Presentation   Printable Slides   Transcript

Final Guidance: Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance and Enforcement Decisions
Presentation   Printable Slides   Transcripts


Medical Device Recalls

Distinguishing Medical Device Recalls from Medical Device Enhancements
Presentation   Printable Slides   Transcript

Introduction to Medical Device Recalls: Industry Responsibilities
Presentation   Printable Slides

Recall Module 21 CFR Part 806: Medical Devices; Reports of Corrections and Removals
Presentation   Printable Slides

Electronic Submission of 806 Reports of Corrections and Removals
Printable Slides

Recall Communication: Medical Device Model Press Release
Presentation   Printable Slides   Transcript

Recall Communication: Medical Device Model Recall Notification Letter
Presentation   Printable Slides   Transcript

Medical Device Recalls: Guidance for Industry
Presentation


Medical Device Reporting (MDR)

Overview of Medical Device Reporting
Presentation   Printable Slides   Transcript

Medical Device Reporting for Mandatory Reporters
Presentation   Printable Slides   Transcript

Electronic Medical Device Reporting (eMDR)
Presentation   Printable Slides   Transcript

Final Guidance on Medical Device Reporting for Manufacturers 
Presentation   Printable Slides   Transcript


我国新型建筑材料的发展趋势及应用

Primer - International Medical Device Regulators Forum (IMDRF) Medical Device Single Audit Program (MDSAP) Pilot
Presentation   Printable Slides   Transcript

1. Introduction to MDSAP
Presentation

2. MDSAP Management
Presentation

3. MDSAP Device Marketing Authorization and Facility Registration
Presentation

4. MDSAP Measurement, Analysis and Improvement
Presentation

5. MDSAP Medical Device Adverse Events and Advisory Notices Reporting
Presentation

6. MDSAP Design and Development
Presentation

7. MDSAP Production and Service Controls, part 1
Presentation

8. MDSAP Production and Service Controls, part 2
Presentation

9. MDSAP Production and Service Controls, part 3
Presentation

10. MDSAP Purchasing
Presentation

1. Unique Device Identification (UDI) System Regulatory Overview
Presentation   Printable Slides   Transcript

2. Global Unique Device Identification Database (GUDID) Account Request: Preparation and Process
Presentation   Printable Slides   Transcript

3. The GUDID Device Identifier (DI) Record
Presentation   Printable Slides   Transcript

4. GUDID HL7 SPL Submission Option
Presentation   Printable Slides   Transcript

5. Optimizing GUDID Data Quality
Presentation   Printable Slides   Transcript

6. Unique Device Identification: Direct Marking of Devices Final Guidance
Presentation   Printable Slides   Transcript

7. Unique Device Identification: Convenience Kits, Final Guidance
北京两共有产权房项目完成申购审核
Presentation   Printable Slides   Transcript

Device-Specific Topics

Dental Devices Premarket Submissions
Presentation   Printable Slides   Transcript

Personal Protective Equipment
Presentation   Printable Slides   Transcript

Within days of becoming Prime Minister of Great Britain, Winston Churchill (Gary Oldman) must face one of his most turbulent and defining trials: exploring a negotiated peace treaty with Nazi Germany, or standing firm to fight for the ideals, liberty and freedom of a nation.

Please note that the 21st Century Cures Act (12/13/2016) clarified FDA's regulation of medical software. The new law amended the definition of "device" in the Food, Drug and Cosmetic Act to exclude certain software functions, including some of those in this presentation.

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. If you have questions about how the 21st Century Cures Act affects your products, or if you have comments on how the FDA should regulate medical software, please email digitalhealth@fda.hhs.gov.

Presentation   Printable Slides   Transcript

Digital Health Software Precertification (PreCert) Pilot Program
Presentation   Printable Slides   Transcript

Overview of the Final Order calling for PMAs for AEDs
Presentation   Printable Slides   Transcript

Self Monitoring Blood Glucose Systems for Over-the-Counter Use & Blood Glucose Monitoring Systems for Prescription Point-of-Care Use 
Presentation   Printable Slides   Transcript


Animal-Related Policy

Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Final Guidance
Presentation   Printable Slides   Transcript


Biocompatibility

Final Guidance on "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
Presentation   Printable Slides   Transcript

Color Additives
Presentation   Printable Slides   Transcript


Collaboration

Collaborative Communities: Addressing Healthcare Challenges Together
Presentation   Printable Slides   Transcript


Custom Devices

Custom Device Exemption
Presentation   Printable Slides   Transcript

Technical Considerations for Additive Manufactured Medical Devices
Presentation   Printable Slides   Transcript


Digital Health

Please note that the 21st Century Cures Act (12/13/2016) clarified FDA's regulation of medical software. The new law amended the definition of "device" in the Food, Drug and Cosmetic Act to exclude certain software functions, including some of those in this presentation.

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. If you have questions about how the 21st Century Cures Act affects your products, or if you have comments on how the FDA should regulate medical software, please email digitalhealth@fda.hhs.gov.

Digital Health Software Precertification (Pre-Cert) Pilot Program
Presentation   Printable Slides   Transcript

Digital Health
Presentation   Printable Slides   Transcript

Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices Final Guidance
Presentation   Printable Slides   Transcript

Clinical Decision Support Software: Draft Guidance
Presentation   Printable Slides   Transcript

Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Final Guidance
Presentation   Printable Slides   Transcript

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Presentation   Printable Slides   Transcript

Postmarket Management of Cybersecurity in Medical Devices Final Guidance 
Presentation   Printable Slides   Transcript

PreCertification (Pre-Cert) Pilot Update
Presentation   Printable Slides   Transcript

Digital Health Center of Excellence Listening Session #1 (New module 10/19/20)
Presentation   Printable Slides   Transcript
TAKE OUR SURVEY - Tell us what you think about the webinar

Digital Health Center of Excellence Listening Session #2 (New module 11/12/20)
Printable Slides


Human Factors

Applying Human Factors and Usability Engineering to Medical Devices
Presentation   Printable Slides   Transcript


Home Use

FDA's Home Use Medical Device Initiative
Presentation   Printable Slides

Promoting Patient Safety with Home Use Devices
Presentation   Printable Slides

Home Use Medical Devices: New Risks
Presentation   Printable Slides

Medical Devices in the Home: Design Considerations and Guidance for Industry
Presentation   Printable Slides   Transcript


In Vitro Diagnostics

Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
Presentation   Printable Slides   Transcript

Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product
Presentation   Printable Slides   Transcript

Final Guidances on Next Generation Sequencing-based Tests
Presentation   Printable Slides   Transcript

Clinical Laboratory Improvement Amendments (CLIA)
Presentation   Printable Slides   Transcript

CLIA Waiver Applications Draft Guidances
Presentation   Printable Slides   Transcript

3D Printed Swabs
Presentation   Printable Slides   Transcript

Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency
Presentation   Printable Slides   Transcript

Clinical Laboratory Improvement Amendments (CLIA) Waiver Applications Final Guidances
Presentation   Printable Slides   Transcript

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - March 25, 2020
Presentation   Printable Slides   Transcript

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - April 1, 2020
Presentation   Transcript

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - April 8, 2020
Presentation   Transcript

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - April 15, 2020
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Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - April 22, 2020
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Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - April 29, 2020
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Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - May 6, 2020
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Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - May 13, 2020
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Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - May 20, 2020
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Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - May 27, 2020 (New module 6/3/20)
Presentation   Transcript

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - June 3, 2020 (New module 6/17/20)
Presentation   Transcript

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - June 10, 2020 (New module 6/25/20)
Presentation   Transcript

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - June 17, 2020 (New module 6/25/20)
Presentation   Transcript

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - June 24, 2020 (New module 6/29/20)
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Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - July 1, 2020 (New module 7/7/20)
Presentation   Transcript

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - July 8, 2020 (New module 7/16/20)
Presentation   Transcript

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - July 8, 2020 (New module 7/21/20)
Presentation   Transcript

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - July 22, 2020 (New module 7/28/20)
Presentation   Transcript

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - July 29, 2020 (New module 8/6/20)
Presentation   Transcript

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - August 5, 2020 (New module 8/10/20)
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Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - August 12, 2020 (New module 8/20/20)
Presentation   Transcript

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - August 19, 2020 (New module 8/27/20)
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Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - August 26, 2020 (New module 9/3/20)
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Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - September 2, 2020 (New module 9/9/20)
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Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - September 9, 2020 (New module 9/22/20)
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Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - September 16, 2020 (New module 9/21/20)
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Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - September 23, 2020 (New module 9/30/20)
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Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - September 30, 2020 (New module 10/7/20)
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Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - October 7, 2020 (New module 10/19/20)
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Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - October 14, 2020 (New module 10/19/20)
Presentation   Transcript

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - October 21, 2020 (New module 10/27/20)
Presentation   Transcript

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - October 28, 2020 (New module 11/9/20)
Presentation   Transcript


Neurological Devices

Regulatory Advice for Investigators and Sponsors of Neurological Devices and the Path to Initiating Human Studies
Presentation   Printable Slides   Transcript

Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to Premarket Approvals 
Presentation   Printable Slides   Transcript

Regulatory Overview for Developers and Sponsors of Neurological and Physical Medicine Devices: An Introduction to the De Novo Pathway (New module 8/27/20)
Presentation   Printable Slides   Transcript

Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to Humanitarian Device Exemptions (HDEs) 
Presentation   Printable Slides   Transcript

FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder
Presentation   Printable Slides   Transcript


张家口家居市场“外在”热闹难掩“实质”低迷

Respirators for Health Care Personnel Use during COVID-19 Pandemic - June 9, 2020 (New module 6/9/20)
Presentation   Printable Slides   Transcript

Respirators for Health Care Personnel Use during COVID-19 Pandemic - June 23, 2020 (New module 6/23/20)
Presentation   Printable Slides   Transcript 

Respirators for Health Care Personnel Use during COVID-19 Pandemic - July 7, 2020 (New module 7/16/20)
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Respirators for Health Care Personnel Use during COVID-19 Pandemic - July 21, 2020 (New module 7/30/20)
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FDA’s Surgical Masks Umbrella EUA - August 18, 2020 (New module 8/27/20)
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CDC/NIOSH's Surgical N95 Respirator Guidance - September 1, 2020 (New module 9/1/20)
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Gowns and Other Apparel for Use by Health Care Personnel in COVID-19 Pandemic (New module 9/15/20)
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Respirators and Other PPE for Health Care Personnel Use (New module 10/14/20)
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Protective Barrier Enclosure Emergency Use Authorizations (EUAs) (New module 10/23/20)
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Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic (Updated module 11/5/20)
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Enforcement Policy for Personal Protective Equipment (PPE) During COVID-19: Immediately in Effect Guidance
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Gowns - Regulatory Responsibilities
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Reprocessing

Webinar - Duodenoscope Sampling and Culturing
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Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
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Sterility

FDA Innovation Challenges: Identify Sterilization Alternatives and Reduce Ethylene Oxide Emissions
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Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Final Guidance
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How to Get Your Electronic Product on the U.S. Market 
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Electronic Product Certification and Quality Testing Programs
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Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Final Guidance
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Pediatric Information for X-ray Imaging Device Premarket Notifications
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Phantom Image Scoring (For MQSA Inspectors)
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eSubmitter Tutorial Presentations
中国涂料月度产量增速水平持续下滑   郑州小区业主被通知搬离:开发商拖欠2千万工程款

510(k) Third Party Review Program: Overview 
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X-Ray Systems
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510(k) Third Party Review Program: Final Guidance510(k) Third Party Review Program: Final Guidance
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Overview of the 510(k) Process: Guide for Third Party Reviewers
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Deficiency Writing for Third Party Reviewers
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Deficiency Writing for Third Party Reviewers: Examples
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November 2019 Industry Basics Workshop: 513(g) Requests for Information and Custom Device Exemption
Full Presentation   Workshop Page

November 2018 Industry Basics Workshop: Production and Process Controls; and Documents, Change Control, and Records
Full Presentation   Workshop Page

November 2017 Industry Basics Workshop: Quality System - Nonconforming Product and Complaint Files
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November 2016 Industry Basics Workshop: Quality System - Management Controls and Design Controls 
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March 2016 Industry Basics Workshop: Unique Device Identification (UDI) Part II, Submitting Information to GUDID 
Full Presentation   Workshop Page

January 2016 Industry Basics Workshop: Unique Device Identification (UDI) Part I
Full Presentation   Workshop Page

November 2015 Industry Basics Workshop: Purchasing Controls and Process Validation
Full Presentation   国务院常务会议:要求积极财政政策要更加积极

November 2014 Industry Basics Workshop: IDE, 510(k), de novo, CAPA, eMDR
Full Presentation   2015年家居消费争议数据解读 警惕装修雷区  

Contact Us

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Center for Devices and Radiological Health
Food and Drug Administration
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Silver Spring, MD 20993

1-800-638-2041
301-796-7100
DICE@fda.hhs.gov



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