FDA Rule Resources for Laboratories

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

FDA rule compliance stage-specific resources are sorted below; resources may appear in multiple sections. 

AMP does NOT certify that the information contained within the linked external resource pages is complete, accurate and/or free of commercial bias. By clicking on an external resource link below, you will leave the AMP website.

If you identify an additional resource for inclusion or find a broken link, please contact us.

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.

*Member-only resource ^$May require purchase

 

Regulation of Laboratory Developed Testing Procedures
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AMP v. FDA lawsuit
Updates on our case.

AMP Resources

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

• AMP's work on LDTs

• AMP v. FDA: A discussion on the lawsuit filing and other related materials

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 or Regulatory Questions        Submit Laboratory Practice or Compliance Questions

Questions sent to FDA: 

• Policy/regulatory — TBD
• Laboratory practice/compliance — TBD

Replies from the FDA:

• 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

• Recently published guidelines and reports

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 (AURP)
• FDA Regulatory Pathways and Programs (LeanRAQA)
• FDA Releases Laboratory-Developed Tests Final Rule (Epstein Becker Green

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 WEBINARS/CDRH LEARN MODULES

• 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
• CDRHNew — 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  

• 5/14/24: 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.) 

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 (AURP)
• FDA Regulatory Pathways and Programs (LeanRAQA)
• FDA Releases Laboratory-Developed Tests Final Rule (Epstein Becker Green)

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

*Or electronic equivalent

Table above has been reproduced from FDA Guidance “Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities,” last accessed 10/19/2024.

Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities, last accessed 10/19/2024 

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)

ADDITIONAL WEBINARS 

• Understanding Post-Market Surveillance (PMS) for Medical Devices (eLeaP)

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)
• 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)

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^$ (not a complete list of available resources)

• 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^$ not a complete list of available resources

• 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 21474-2:2022 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification
• 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:CLIS) 
• ISO15189WR Medical Laboratories—Requirements for Quality and Competence: Changes from the Third Edition (2012) to the Fourth Edition (2022) Webinar 
• QMSR Masterclass  
• Unpacking FDA Guidance: Quality System Considerations and Content of Premarket Submissions (MedCrypt)
• 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^$ (not a complete list of available resources)

• 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

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

Premarket Notification (510(k)) 

• 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) 

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 (MedCrypt)

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 

• September 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
• 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) 
• 4/30/2024: 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^$ not a complete list of available resources

• 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) 

CLSI^$ (not a complete list of available resources)

• 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)
• What are the Benefits of 3rd Party FDA Reviewers? (LeanRAQA)
• 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 (MedCrypt)

Disclaimer: With the exception of resources labeled above as having been generated by AMP, links will take you to external websites. Resources above are the sole responsibility of the entity providing them. AMP does not endorse any commercial product or service. AMP makes no warranty, express or implied, regarding any commercial product or service, and hereby disclaims, the accuracy, completeness, timeliness or merchantability or fitness for a particular purpose of the content and associated materials presented above. AMP shall not be liable for any damages, including direct, indirect, special, incidental, or consequential or any other type of damages arising out of or related to the use of the information contained on this page or associated materials.