FDA Rule Resources for Laboratories

AMP maintains the following list of resources as a service to our membership and the molecular laboratory community. Check back often - this page will update when new information becomes available.  

If you need specific guidance or assistance with compliance with the FDA medical device regulations,  

AMP encourages you to seek out licensed counsel and/or certified regulatory affairs professionals.

Quick links to sections below 

AMP Resources              Code of Federal Regulations  Regulatory Education Resources (non-FDA)

FDA Center for Devices and Radiological Health (CDRH)      FDA Final Rule Informational / Impact of Final Rule Resources

STAGE 1: Medical Device Reporting (MDR), Correction & Removal Reporting, & Complaint File

STAGE 2: Registration & Listing, Labeling, Investigational Device Exemption (IDE)

STAGE 3: Quality System Requirements (QSR), Design Controls, Purchasing Controls, Acceptance Activities, Corrective & Preventative Actions, Records Requirements

STAGE 4: Premarket Approval (PMA) Required for High-risk In Vitro Diagnostics (IVDs)

New York State DOH LDT 3rd Party Review Program         FDA CDER Medical Device Digital Health Resources Molecular Testing Validation Resources

AMP Resources 

AMP Members, use the CHAMP community when you have questions for your AMP colleagues Visit CHAMP

AMP Resource Center on the FDA Final Rule on LDTs 

Q & A WITH THE FDA  

AMP will collect your professional questions, send them to the FDA, and anonymously post the answers received below.  

Site-specific questions? Contact LDTFinalRule@fda.hhs.gov, licensed counsel, and/or certified regulatory affairs professionals. 

SUBMIT POLICY / REGULATORY QUESTIONS

SUBMIT LABORATORY PRACTICE / COMPLIANCE QUESTIONS 

Questions sent to FDA: (updated 9/30/2024) 

• Policy / regulatory - TBD 

• Laboratory practice / compliance – TBD 

Replies from the FDA: (updated 9/30/2024) 

• Policy / regulatory - TBD 

• Laboratory practice / compliance – TBD 

WEBINARS 

5/9/2024: Final Rule: FDA Rule Medical Device; Laboratory Developed Tests Slides 

9/16/2024: A Discussion on the Recent AMP Lawsuit Filing Slides 

PRACTICE GUIDELINES  

Code of Federal Regulations 

Federal Register - Medical Devices; Laboratory Developed Tests (FDA Final Rule, 5/6/2024) 

Code of Federal Regulations (CFR) Title 21 Part 803 -- MEDICAL DEVICE REPORTING key terms are defined 

Final Rule on Electronic Medical Device Reporting (eMDR) 

Proposed Rule: Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices (9/25/2024) 

Regulatory Education Resources (non-FDA) 

DOCUMENTS (see stages below for additional resources) 

Navigating FDA’s LDT Final Rule: Key Terminology Every Clinical Lab Should Know (Today’s Clinical Lab) 

WEBINARS (see stages below for additional resources) 

Regulatory Education for Industry (REdI) Annual Conference 2024 (5/29-30/2024) 

• CDRH (Devices) Innovation in Medical Product Development (Day 1 of 2)   

• CDRH (Devices) Innovation in Medical Product Development (Day 2 of 2)  

Professional Association Sponsored 

• Final Rule: FDA Rule Medical Device; Laboratory Developed Tests  slides (AMP) 

• The U.S. Food and Drug Administration’s rule on laboratory developed tests — What it means for you (ADLM) 

• Countdown to Compliance: What You Need to Know About the FDA’s New Rule (AAPath)* 

• Navigating the FDA Approval Process: Successes and Pitfalls from Complex NGS and MPX (AAPath)* 

• Preparing for Implementation of FDA's Laboratory-Developed Test Final Rule (CAP) 

• Overview of FDA Laboratory Developed Test Final Rule (ASCP)* 

• Update on the Regulation of LDTs: FDA, VALID Act, CLIA Modernization, and More (ACMG) 

Assorted sponsors 

• LDT vs IVD: Adapting to the New FDA Regulations (MCRA)  

• What the FDA’s Proposed Rule to Regulate Lab-Developed Tests Means for Hospitals and Health Systems  

• FDA Regulatory Pathways and Programs  

• FDA Releases Laboratory-Developed Tests Final Rule  

FDA Center for Devices and Radiological Health (CDRH) 

Wherever possible, FDA guidance is sorted on this webpage by the applicable FDA Rule compliance stage 

FDA MEDICAL DEVICE WEBSITES AND ONLINE RESOURCES 

FDA FINAL RULE: Federal Register - Medical Devices; Laboratory Developed Tests (5/6/2024) 

Laboratory Developed Tests (LDTs)  

Medical Devices  

Medical Device User Fees  

Medical Device Reporting (MDR): How to Report Medical Device Problems  

CDRHNews - News and Updates  

FDA CDRH Events (including webinars)  

Total Product Life Cycle Advisory Program (TAP) 

FDA WEBINARS  

CDRH Learn 

5/14/2024: Final Rule: Medical Devices; Laboratory Developed Tests 

6/5/2024: Draft Guidances on Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 (applicable to LDTs) and Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency (applicable to IVDs) 

7/16/2024: In Vitro Diagnostic Product (IVD): Classification 

10/24/2024: FDA’s Total Product Lifecycle Approach to In Vitro Diagnostic Products 

FDA PUBLISHED GUIDANCE DOCUMENTS 

Laboratory Developed Tests: Frequently Asked Questions 

Laboratory Developed Tests: Small Entity Compliance Guide 

Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564 - Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff 

FDA MEDICAL DEVICE DATABASES 

Establishment Registration & Device Listing 

Recognized Consensus Standards: Medical Devices 

Search for FDA Guidance Documents 

Clinical Laboratory Improvement Amendments (CLIA) 

Device Classification 

510(k) Premarket Notification 

Premarket Approval (PMA) 

Device Classification Under Section 513(f)(2)(De Novo) 

Manufacturer and User Facility Device Experience (MAUDE) Database 

CDRH Export Certificate Validation (CECV) 

CDRH FOIA Electronic Reading Room 

CFR - Code of Federal Regulations Title 21 

Humanitarian Device Exemption (HDE) 

Medical Product Safety Network (MedSun) Reports 

Post-Approval Studies (PAS)  

522 Postmarket Surveillance Studies  

Medical Device Recalls 

Total Product Life Cycle (TPLC) 

FDA Final Rule Informational / Impact of Final Rule Resources 

FDA MEDICAL DEVICE WEBSITES AND ONLINE RESOURCES 

CDRHNew - News and Updates 

FDA CDRH Events (including webinars)  

Total Product Life Cycle Advisory Program (TAP) 

Coronavirus (COVID-19) and Medical Devices 

Definitions and General Oversight: Laboratory Developed Tests FAQs 

Specific Test Categories or Technologies: Laboratory Developed Tests FAQs 

Phaseout Policy and Enforcement Discretion Policies: Laboratory Developed Tests FAQs 

Premarket Review: Laboratory Developed Tests FAQs 

Resources and Interactions with FDA: Laboratory Developed Tests FAQs 

Labeling: Laboratory Developed Tests FAQs 

Medical Device Reporting, Complaints, and Corrections & Removals Reporting: Laboratory Developed Tests FAQs 

Investigational Use: Laboratory Developed Tests FAQs 

FDA PUBLISHED GUIDANCE 

8/22/2024 Draft Guidance: Predetermined Change Control Plans for Medical Devices 

Proposed Rule: Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices (9/25/2024) 

FDA WEBINARS / CDRH LEARN MODULES  

5/20/24: Laboratory Developed Tests; Medical Devices: Final Rule Slides Transcript 

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

How is CDRH Structured? Slides Transcript 

Is My Product a Medical Device? Slides Transcript 

An Introduction to the Medical Device User Fee Program: MDUFA V Slides Transcript 

Standards 

• Module 1: Standards Overview Slides Transcript 

• Module 2: Standards Resources and Premarket Use Slides Transcript 

• Module 3: CDRH Standards Recognition Process Slides Transcript 

• Module 4: How to Use Consensus Standards in Premarket Submissions Slides Transcript 

• Module 5: The ASCA Pilot: Streamlining Conformity Assessment in Device Submissions Slides Transcript 

• Webinar - ASCA Pilot: Streamlining Conformity Assessment in Device Submissions Slides  Transcript 

• Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidances Slides Transcript 

• Appropriate Use of Voluntary Consensus Standards Slides Transcript 

• Recognition and Withdrawal of Voluntary Consensus Standards - Final Guidance Slides Transcript 

Cross-Cutting Premarket Policy 

• CDRH Portal Overview and Feature Walkthrough Slides Transcript 

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

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

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

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

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

• Multiple Function Device Products: Policy and Considerations Slides Transcript 

• Patient Preference?Information? Slides Transcript 

• 9/11/24: Predetermined Change Control Plans for Medical Devices, Draft Guidance Slides  Transcript 

• Safer Technologies Program: Draft Guidance Slides 

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

510(k) Third Party Review Program (intended for Third Party Review Programs) 

• 510(k) Third Party Review Program: Overview? Transcript 

• 510(k) Third Party Review Program: Final Guidance510(k) Third Party Review Program: Final Guidance Slides Transcript 

• Overview of the 510(k) Process: Guide for Third Party Reviewers  Slides Transcript 

• Deficiency Writing for Third Party Reviewers  Slides Transcript 

• Deficiency Writing for Third Party Reviewers: Examples  Slides Transcript 

De Novo 

• De Novo Final Rule: Overview and Guidance Updates Slides Transcript 

• De Novo Program Slides Transcript 

DOCUMENT RESOURCES 

Navigating FDA’s LDT Final Rule: Key Terminology Every Clinical Lab Should Know (Today’s Clinical Lab) 

Summary and analysis of Food and Drug Omnibus Reform Act of 2022 (Hyman, Phelps & McNamara, P.C.) 

ONLINE RESOURCES 

ADDITIONAL WEBINARS 

Professional Association sponsored 

• Final Rule: FDA Rule Medical Device; Laboratory Developed Tests  slides (AMP) 

• The U.S. Food and Drug Administration’s rule on laboratory developed tests — What it means for you (ADLM) 

• Countdown to Compliance: What You Need to Know About the FDA’s New Rule (AAPath)* 

• Navigating the FDA Approval Process: Successes and Pitfalls from Complex NGS and MPX (AAPath)* 

• Preparing for Implementation of FDA's Laboratory-Developed Test Final Rule (CAP) 

• Overview of FDA Laboratory Developed Test Final Rule (ASCP)* 

• Update on the Regulation of LDTs: FDA, VALID Act, CLIA Modernization, and More (ACMG) 

Assorted sponsors 

• LDT vs IVD: Adapting to the New FDA Regulations (MCRA)  

• What the FDA’s Proposed Rule to Regulate Lab-Developed Tests Means for Hospitals and Health Systems  

• FDA Regulatory Pathways and Programs  

• FDA Releases Laboratory-Developed Tests Final Rule  

STAGE 1: Medical Device Reporting (MDR), Correction & Removal Reporting, & Complaint File  

Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities, last accessed 9/19/2024 

FDA MedWatch Form 3500A  

FDA MedWatch Form 3500A Supplement – General Instructions for Form 3500A 

FDA MEDICAL DEVICE WEBSITES AND ONLINE RESOURCES 

FDA Electronic Submissions Gateway (ESG)  

For assistance with the registration or testing process, contact?ESGHelpDesk@fda.hhs.gov? 

• Setting up a WebTrader Account Checklist  

• ESG User Portal (https://esgportal.fda.gov/) 

• ESG Account Management Portal User Guide 

• ESG User Guide 

• Tutorials 

• WebTrader System Requirements 

• WebTrader Test website:https://esgtest.fda.gov/ 

• ESG WebTrader Production application: https://esg.fda.gov/ 

Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities 

Options for manufacturers and importers to electronically submit Medical Device Reporting (MDRs): 

• Web Interface using the eSubmitter application 

• AS2 Gateway-to-Gateway using HL7 ICSR XML 

Medical Device Reporting (MDR) - Contact Information for User Facilities and Manufacturers 

FDA Manufacturer and User Facility Device Experience (MAUDE) database 

Reporting Allegations of Regulatory Misconduct 

Allegations of Regulatory Misconduct Form 

CDRH FOIA: How to Get Records from CDRH 

Appendix G: Letters of Non-Repudiation Agreement 

Voluntary Malfunction Summary Reporting Program webpage 

Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices  

Medical Device Reporting, Complaints, and Corrections & Removals Reporting: Laboratory Developed Tests FAQs 

FDA PUBLISHED GUIDANCE 

Code of Federal Regulations (CFR) Title 21 Part 803 -- MEDICAL DEVICE REPORTING key terms are defined 

Final Rule on Electronic Medical Device Reporting (eMDR) 

Questions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA Staff 

Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers; Guidance for Industry and Food and Drug Administration Staff 

Recalls, Corrections and Removals (Devices) 

FDA WEBINARS / CDRH LEARN MODULES  

Complaint Files (presentation) 

8/22/2024: In Vitro Diagnostic Products (IVDs) - MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint Requirements 

12/3/2024: Webinar – Registration & Listing Requirements for In Vitro Diagnostic Products (IVDs), Including Laboratory Developed Tests (LDTs)  

Registration and Listing 

• Device Registration and Listing: An Introduction – Part 1 Slides Transcript 

• Device Registration and Listing: An Introduction – Part 2 Slides Transcript 

• Paying the Annual Registration User Fee via the Device Facility User Fee (DFUF) Slides 

Medical Device Reporting (MDR) 

• Overview of Medical Device Reporting Slides Transcript 

• Medical Device Reporting for Mandatory Reporters Slides Transcript 

• Electronic Medical Device Reporting (eMDR) Slides Transcript 

• Final Guidance on Medical Device Reporting for Manufacturers Slides Transcript 

• eMDR eSubmitter and WebTrader Tutorial Transcript 

Medical Device Recalls 

• Introduction to Medical Device Recalls Slides Transcript 

• Distinguishing Medical Device Recalls from Medical Device Enhancements Slides Transcript 

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

• Electronic Submission of 806 Reports of Corrections and Removals Slides 

Inspections - Global Harmonization 

• (1A) Introduction to the MDSAP Program Slides Transcript 

• (1B) Overview of the MDSAP Audit Process Slides Transcript 

• (2) MDSAP: Management Process Slides Transcript 

• (3) MDSAP: Device Marketing Authorization and Facility Registration Slides Transcript 

• (4) MDSAP: Measurement, Analysis and Improvement Process Slides Transcript 

• (5) MDSAP: Medical Device Adverse Events and Advisory Notices Reporting Process Printable Slides Transcript 

• (6) MDSAP: Design and Development Process Slides Transcript 

• (7) MDSAP: Production and Service Controls Process, Part 1 Slides Transcript 

• (8) MDSAP: Production and Service Controls Process: Part 2 Slides Transcript 

• (9) MDSAP: Production and Service Controls Process: Part 3 Slides Transcript 

• (10) MDSAP: Purchasing Process Slides Transcript 

QUESTIONS ABOUT MEDICAL DEVICE REPORTING, including interpretation of MDR policy 

DOCUMENT RESOURCES 

Navigating FDA’s LDT Final Rule: Key Terminology Every Clinical Lab Should Know (Today’s Clinical Lab) 

ONLINE RESOURCES 

ADDITIONAL WEBINARS 

Understanding Post-Market Surveillance (PMS) for Medical Devices  

STAGE 2: Registration & Listing, Labeling, Investigational Device Exemption (IDE)  

FDA WEBSITES AND ONLINE RESOURCES 

FDA Establishment Registration & Device Listing Database 

Labeling: Laboratory Developed Tests FAQs 

Investigational Use: Laboratory Developed Tests FAQs 

FDA PUBLISHED GUIDANCE 

Device Registration and Listing 

In Vitro Diagnostic Device Labeling Requirements 

Device Labeling 

Investigational?Device Exemption (IDE) | FDA 

Proposed Rule: Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices (9/25/2024) 

FDA WEBINARS / CDRH LEARN MODULES 

9/24/2024: Labeling Requirements for In Vitro Diagnostic Products (IVD), including LDTs, Under 21 CFR 809.10(b) 

Clinical Studies/Investigational Device Exemption (IDE) 

• IDE Basics Slides Transcript 

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

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

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

• Breakthrough Devices Program, Updated Final Guidance [2023] Slides Transcript 

• Breakthrough Devices Program [2019] Slides Transcript 

• Strengthening the Medical Device Clinical Trial Enterprise Slides Transcript 

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

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

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

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

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

• Clinical Studies/IDE Slides Transcript 

• Post-Approval Study Requirements and Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act, Final Guidances Slides Transcript 

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

Humanitarian Use Device (HUD)/Humanitarian Device Exemption (HDE) 

• HDE Module 1: Office of Orphan Products Development Slides Transcript 

• HDE Module 2: Humanitarian Use Device (HUD): Program Overview Slides Transcript 

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

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

• Humanitarian Device Exemption Program Slides Transcript 

DOCUMENT RESOURCES 

Navigating FDA’s LDT Final Rule: Key Terminology Every Clinical Lab Should Know (Today’s Clinical Lab) 

ONLINE RESOURCES 

ADDITIONAL WEBINARS 

STAGE 3: Quality System Requirements (QSR), Design Controls, Purchasing Controls, Acceptance Activities, Corrective & Preventative Actions, Records Requirements  

FDA PUBLISHED GUIDANCE 

QS Regulation/Medical Device Current Good Manufacturing Practices (CGMP) 

Medical Device Reporting, Complaints, and Corrections & Removals Reporting: Laboratory Developed Tests FAQs 

WEBINARS / CDRH LEARN MODULES 

Overview of the Quality System (Start here!) 

• Overview of the Quality System Slides Transcript 

• Production and Process Controls Slides Transcript 

• Production and Process Controls, Part 2 Slides Transcript 

• Documents, Change Control, and Records Slides Transcript 

• Design Controls Slides Transcript 

• Risk Basics for Medical Devices Slides Transcript 

• Application of Risk Management Principles for Medical Devices Slides Transcript 

• Management Controls Slides Transcript 

• Purchasing Controls Slides Transcript 

• Process Validation Slides Transcript 

• Corrective and Preventive Actions Slides Transcript 

• Nonconforming Product Slides Transcript 

• Complaint Files Slides Transcript 

Quality Management System Regulation (8/30/24) 

• Overview of Quality Management System Regulation Slides Transcript 

• Navigating the Quality Management System Regulation Slides Transcript 

Exports and Imports 

• Exporting Medical Devices Slides Transcript 

• Importing Medical Devices Into the United States 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 Slides Transcript 

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

• 9/17/24: Remanufacturing of Medical Devices, Final Guidance Slides Transcript 

• Computer Software Assurance for Production and Quality System Software, Draft Guidance Slides Transcript 

FDA RECOGNIZED STANDARDS (not an exhaustive list) 

CLSI^$ 

• CLSI - Crosswalk of Documents Referenced Within FDA Accreditation Checklists FREE 

• CLSI EP36 Harmonization of Symbology and Equations, 1st Edition FREE 

• CLSI QSRLDT Quality System Regulations for Laboratory-Developed Tests: A Practical Guide for the Laboratory, 2nd Ed FREE 

• CLSI QMS01 A Quality Management System Model for Laboratory Services, 5th Edition 

• CLSI QMS01CL Gap Analysis Checklists, 1st Edition 

• CLSI QMS02 Developing and Managing Laboratory Documents, 7th Edition 

• CLSI QMS02QG Ten Rules for Laboratory Document Management Quick Guide, 7th Edition 

• CLSI QMS03 Training and Competence Assessment, 4th Edition 

• CLSI QMS04 Laboratory Design, 3rd Edition 

• CLSI QMS05 Qualifying, Selecting, and Evaluating a Referral Laboratory, 3rd Edition 

• CLSI QMS06 Quality Management System: Continual Improvement, 3rd Edition 

• CLSI QMS11 Nonconforming Event Management, 2nd Edition 

• CLSI QMS12 Development and Use of Quality Indicators for Process Improvement and Monitoring of Laboratory Quality, 2nd Edition 

• CLSI QMS13 Quality Management System: Equipment, 1st Edition 

• CLSI QMS14 Quality Management System: Leadership and Management Roles and Responsibilities, 1st Edition 

• CLSI QMS15 Laboratory Internal Audit Program, 2nd Edition 

• CLSI QMS16 Laboratory Personnel Management, 1st Edition 

• CLSI QMS17 External Assessments, Audits, and Inspections of the Laboratory, 2nd Edition 

• CLSI QMS18 Process Management, 2nd Edition 

• CLSI QMS19 Customer Focus in a Quality Management System, 1st Edition 

• CLSI QMS20 The Cost of Quality in Medical Laboratories, 2nd Edition 

• CLSI QMS21 Purchasing and Inventory Management, 1st Edition 

• CLSI QMS22 Management of Paper-based and Electronic Laboratory Information, 1st Edition 

• CLSI QMS23 General Laboratory Equipment Performance Qualification, Use, and Maintenance, 2nd Edition 

• CLSI QMS24 Using Proficiency Testing and Alternative Assessment to Improve Medical Laboratory Quality, 3rd Edition 

• CLSI QMS25 Handbook for Developing a Laboratory Quality Manual, 1st Edition 

• CLSI QMS26 Managing Laboratory Records, 1st Edition 

• CLSI QMS29 Management Review, 1st Edition 

• CLSI MM20 Quality Management for Molecular Genetic Testing, 1st Edition 

• CLSI POCT07 Quality Management: Approaches to Reducing Errors at the Point of Care, 1st Edition FREE for a limited time 

• CLSI EPLDT Quick Guide Validating Performance Claims for Laboratory-Developed Tests, 1st Edition FREE 

• CLSI EP19 A Framework for Using CLSI Documents to Evaluate Medical Laboratory Test Methods, 3rd Edition FREE 

ISO Documents^$

• Full catalogue of ISO documents (CLSI) 

• ISO 15189:2022 Medical laboratories — Requirements for quality and competence 

• ISO 15198:2004 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer 

• ISO 15194:2009 In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation 

• ISO 21474-1:2020 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation (CLSI)  

• ISO 21474-1:2020 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation (CLSI) 

• ISO 17511-Ed2:2020 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples, 2nd Edition 

• ISO 22367:2020 Medical laboratories — Application of risk management to medical laboratories 

• ISO 23640:2011 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents 

• ISO 35001:2019 Biorisk Management for Laboratories and Other Related Organizations 

• ISO/TS 20914:2019 Medical laboratories — Practical guidance for the estimation of measurement uncertainty 

OTHER WEBINARS 

CLSI Quality Management Systems webinars (multiple) 

ISO15189WR Medical Laboratories—Requirements for Quality and Competence: Changes from the Third Edition (2012) to the Fourth Edition (2022) Webinar 

QMSR to ISO  

QMSR Masterclass  

Unpacking FDA Guidance: Quality System Considerations and Content of Premarket Submissions   

QSR to QMSR: The Rewrite of 21 CFR Part 820 & Key Considerations for FDA Compliance (Greenlight Guru)   

DOCUMENT RESOURCES 

Navigating FDA’s LDT Final Rule: Key Terminology Every Clinical Lab Should Know (Today’s Clinical Lab) 

ONLINE RESOURCES 

CLSI^$

• CLSI LQMS Online Package LQMS - Laboratory Quality Management System Certificate Program PKG 

• CLSI LQMSO Les Paquete digital de Programa de Certificación del CLSI en el Sistema de Gestión de la Calidad en el Laboratorio 

• CLSI QMS15OL Laboratory Internal Auditing Course 

• CLSI Cost of Quality Course 

ADDITIONAL WEBINARS 

STAGE 4: Premarket Approval (PMA) Required for High-risk In Vitro Diagnostics (IVDs)  

FDA WEBSITES AND ONLINE RESOURCES 

FDA Device Classification Database 

Definitions and General Oversight: Laboratory Developed Tests FAQs 

Specific Test Categories or Technologies: Laboratory Developed Tests FAQs 

Phaseout Policy and Enforcement Discretion Policies: Laboratory Developed Tests FAQs 

Premarket Review: Laboratory Developed Tests FAQs 

Resources and Interactions with FDA: Laboratory Developed Tests FAQs 

FDA PUBLISHED GUIDANCE 

Premarket Submissions: Selecting and Preparing the Correct Submission | FDA 

The Special 510(k) Program 

Deciding When to Submit a 510(k) for a Change to an Existing Device 

8/22/2024 Draft Guidance: Predetermined Change Control Plans for Medical Devices 

Proposed Rule: Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices (9/25/2024) 

FDA WEBINARS / CDRH LEARN MODULES 

Risk Basics for Medical Devices  

Application of Risk Management Principles for Medical Devices  

6/11/2024: Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances Slides Transcript 

8/18/2024: In Vitro Diagnostic Product (IVD): Classification Slides Transcript 

Classification 

• How is My Medical Device Classified? Slides Transcript 

• Case Study: How is My Medical Device Classified? Slides Transcript 

• 513(g) Requests for Information Slides Transcript 

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

Premarket Approval Application (PMA) 

• Introduction to the Premarket Approval Application (PMA) ProgramSlides Transcript 

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

Premarket Notification (510k) 

• The 510(k) Program Slides Transcript 

• CDRH's New Draft Guidances to Continue to Modernize the 510(k) Program Slides Transcript 

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

• Safety and Performance Based Pathway Criteria for Certain Device Types Final Guidances Slides Transcript 

• Safety and Performance Based Pathway Performance Criteria Slides Transcript 

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

Q-Submissions 

• Q-Submission Program for Medical Device Submissions Slides Transcript 

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

Cross-Cutting Premarket Policy 

• CDRH Portal Overview and Feature Walkthrough Slides Transcript 

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

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

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

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

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

• Multiple Function Device Products: Policy and Considerations Slides Transcript 

• Patient Preference Information Slides Transcript 

• 9/11/24: Predetermined Change Control Plans for Medical Devices, Draft Guidance Slides Transcript 

• Safer Technologies Program: Draft Guidance Slides 

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

De Novo 

• De Novo Final Rule: Overview and Guidance Updates Slides Transcript 

• De Novo Program Slides Transcript 

DOCUMENT RESOURCES 

Navigating FDA’s LDT Final Rule: Key Terminology Every Clinical Lab Should Know (Today’s Clinical Lab) 

ONLINE RESOURCES 

ADDITIONAL WEBINARS 

LDT vs IVD: Adapting to the New FDA Regulations (MCRA)  

Understanding the FDA Pre-Market Approval (PMA) Process for Medical Devices (eLeap)  

10 Steps to Preparing Your 510(k) Submission (and How to Avoid the Common Pitfalls) (Greenlight Guru)  

Unpacking FDA Guidance: Quality System Considerations and Content of Premarket Submissions  

New York State DOH LDT 3rd Party Review Program

Only laboratories that hold a New York State clinical laboratory permit are authorized to perform testing on specimens originating from New York. Review of LDT begins after the clinical laboratory permit application has been submitted. LDT review is not offered as a stand-alone service.

NYSDOH RESOURCES 

Obtain a NYS Clinical Laboratory Permit 

Certificate of Qualification & Laboratory Director Requirements 

Application Procedures for Test Approval 

Tiered Evaluation of Laboratory Developed Tests Policy

• Submission checklist

• Risk Attestation Form

• Genetic Testing Molecular Checklist 

• Guidelines for Germline Variant Detection Using Next Generation Sequencing (NGS) 

• Microbiology Molecular Checklist 

• MALDI-TOF Assays in Microbiology Checklist 

• Validation of Next Generation Sequencing (NGS) Methods for Identification and/or Characterization of Infectious Agents 

• Oncology Molecular Checklist 

• Guidelines for Somatic Variant Detection Using Next Generation Sequencing (NGS) 

DOCUMENT RESOURCES 

Sept 2024: NYS Clinical Laboratory Association Newsletter – FDA’s Final Rule Regulating LDTs (Jane Pine Wood) 

FDA CDER Medical Device Digital Health Resources 

FDA MEDICAL DEVICE WEBSITES AND ONLINE RESOURCES 

3/13/2024: Draft Guidance: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act  

09/27/2023: Final Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices  

FDA Digital Health and Artificial Intelligence Glossary – Educational Resource 

Playbook for Threat Modeling Medical Devices 

1/02/2023: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions  

Next Steps Toward Managing Legacy Medical Device Cybersecurity Risks (FDA via contract with MITRE) 

Software as a Medical Device (SaMD)  

Artificial Intelligence and Machine Learning in Software as a Medical Device website 

Listing of Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices  

Good Machine Learning Practice for Medical Device Development: Guiding Principles  

Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles  

Guidances with Digital Health Content  

Cybersecurity in Medical Devices Frequently Asked Questions (FAQs)  

Your Clinical Decision Support Software: Is It a Medical Device?  

FDA WEBINARS / CDRH LEARN MODULES 

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

Clinical Decision Support Software, Final Guidance Transcript 

Content of Premarket Submissions for Device Software Functions, Final Guidance Slides Transcript 

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Final Guidance Slides Transcript 

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

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions Slides Transcript 

Postmarket Management of Cybersecurity in Medical Devices Final Guidance? Slides Transcript 

5/9/2024: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act, Draft Guidance Slides Transcript 

Molecular Testing Validation Resources

FDA MEDICAL DEVICE WEBSITES AND ONLINE RESOURCES 

Definitions and General Oversight: Laboratory Developed Tests FAQs 

Specific Test Categories or Technologies: Laboratory Developed Tests FAQs 

Phaseout Policy and Enforcement Discretion Policies: Laboratory Developed Tests FAQs 

Premarket Review: Laboratory Developed Tests FAQs 

Resources and Interactions with FDA: Laboratory Developed Tests FAQs 

Labeling: Laboratory Developed Tests FAQs 

Medical Device Reporting, Complaints, and Corrections & Removals Reporting: Laboratory Developed Tests FAQs 

Investigational Use: Laboratory Developed Tests FAQs 

FDA PUBLISHED GUIDANCE 

Proposed Rule: Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices (9/25/2024) 

FDA WEBINARS / CDRH LEARN MODULES 

See STAGE 3 section above - FDA Webinars / CDRH Learn Modules about QSR / QMSR  

Standards 

• Module 1: Standards Overview Slides Transcript 

• Module 2: Standards Resources and Premarket Use Slides Transcript 

• Module 3: CDRH Standards Recognition Process Slides Transcript 

• Module 4: How to Use Consensus Standards in Premarket Submissions Slides Transcript 

• Appropriate Use of Voluntary Consensus Standards Slides Transcript 

• Recognition and Withdrawal of Voluntary Consensus Standards - Final Guidance Slides Transcript 

FDA RECOGNIZED STANDARDS FOR MOLECULAR TESTING (not an exhaustive list) 

CLSI^$

• CLSI - Crosswalk of Documents Referenced Within FDA Accreditation Checklists FREE 

• CLSI Standards  

• CLSI free resources 

• CLSI EP36 Harmonization of Symbology and Equations, 1st Edition FREE 

• CLSI MM01 Molecular Testing for Heritable Genetics and Specimen Identification, 4th Edition 

• CLSI MM03 Molecular Diagnostic Methods for Infectious Diseases, 3rd Edition 

• CLSI MM05 Nucleic Acid Amplification Assays for Molecular Hematopathology, 2nd Edition 

• CLSI MM06 Quantitative Molecular Methods for Infectious Diseases, 2nd Edition 

• CLSI MM07 Fluorescence In Situ Hybridization Methods for Clinical Laboratories, 2nd Edition 

• CLSI MM09: Human Genetic and Genomic Testing Using Traditional and High-Throughput Nucleic Acid Sequencing Methods, 3rd Edition 

• CLSI MM11 Molecular Methods for Bacterial Strain Typing, 1st Edition 

• CLSI MM12 Diagnostic Nucleic Acid Microarrays, 1st Edition 

• CLSI MM13 Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods, 2nd Edition 

• CLSI MM14 Design of Molecular Proficiency Testing/External Quality Assessment, 2nd Edition FREE for a limited time 

• CLSI MM17 Validation and Verification of Multiplex Nucleic Acid Assays, 2nd Edition 

• CLSI MM18 Interpretive Criteria for Identification of Bacteria and Fungi by Targeted DNA Sequencing, 2nd Edition 

• CLSI MM19 Establishing Molecular Testing in Clinical Laboratory Environments, 1st Edition 

• CLSI MM20 Quality Management for Molecular Genetic Testing, 1st Edition 

• CLSI MM21 Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications, 1st Edition 

• CLSI MM22 Microarrays for Diagnosis and Monitoring of Infectious Diseases, 2nd Edition 

• CLSI MM23 Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms), 1st Edition 

• CLSI MM24 Molecular Methods for Genotyping and Strain Typing of Infectious Organisms, 1st Edition 

• CLSI MM26 Cancer Molecular Testing: Principles of Oncology Test Interpretation, Laboratory and Assay Design, and Clinical Consultation, 1st Edition 

• CLSI EPLDT Quick Guide Validating Performance Claims for Laboratory-Developed Tests, 1st Edition FREE 

• CLSI EP19 A Framework for Using CLSI Documents to Evaluate Medical Laboratory Test Methods, 3rd Edition FREE 

• CLSI Micro Free (formerly M100 Free) read-only access to M100, M23, M23 Supplements, M27M44S, and M45 

• CLSI Breakpoint Implementation Toolkit Download entire toolkit FREE 

• CLSI AST Rationale Documents Package of Rationale Documents FREE 

• CLSI GP36 Planning for Laboratory Operations During a Disaster, 1st Edition FREE for a limited time 

• CLSI POCT07 Quality Management: Approaches to Reducing Errors at the Point of Care, 1st Edition FREE for a limited time 

• CLSI POCT18 Selection Process for CLIA-Waived Testing for SARS-CoV-2, Respiratory Syncytial Virus, and Influenza Viruses, 1st Edition FREE for a limited time 

ISO^$

• Full catalogue of ISO documents (CLSI) 

• ISO 21474-1:2020 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation (CLSI)  

• ISO 21474-1:2020 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation (CLSI) 

• ISO 17822:2020 In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens - Laboratory quality practice guide 

• ISO 21474-2:2022 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification 

DOCUMENT RESOURCES 

CLSI LDT Response Documents  

Navigating FDA’s LDT Final Rule: Key Terminology Every Clinical Lab Should Know (Today’s Clinical Lab) 

ONLINE RESOURCES 

ADDITIONAL WEBINARS 

CLSI^$

• CLSI On-Demand Regulatory Webinar Streamline the FDA Approval Journey: A Panel Discussion with the FDA, CLSI, and Abbott Laboratories 

• CLSI MM26 Webinar | Leading a Successful and Quality Molecular Oncology Laboratory: Actionable Guidance for Laboratory Directors and Supervisors from CLSI MM26 

• CLSI MM09: Modernizing Guidance for Clinical Sequencing: Human Genetic and Genomic Testing Using Traditional and High-Throughput Nucleic Acid Sequencing Methods Webinar 

• CLSI MM03 Overview: Molecular Diagnostic Methods for Infectious Diseases Webinar 

• CLSI EP17 Free Overview Webinar: EP17 Overview: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures Webinar 

• CLSI QMS03 Overview Webinar: Using QMS03, Training and Competence Assessment, On-Demand Webinar 

• CLSI EP 2024 Webinar What's New in Method Evaluation? 

• CLSI LDT Webinar LDT Foundations Webinar Series: Exploring Standards that Support LDT Developers 

Assorted sponsors 

• Understanding the FDA Pre-Market Approval (PMA) Process for Medical Devices (eLeap)  

• FDA Software Validation Documentation: All you need to know  

• What are the Benefits of 3rd Party FDA Reviewers?  

• 10 Steps to Preparing Your 510(k) Submission (and How to Avoid the Common Pitfalls) (Greenlight Guru)  

• Unpacking FDA Guidance: Quality System Considerations and Content of Premarket Submissions