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PPT-00129 REV01 21 CFR Part 861 Procedures for Performance Standards Development
  • performance standard development

21 CFR Part 861 21 CFR Part 861

00128 REV01 21 CFR Part 860 Medical Device Classification
  • classification

21 CFR Part 860 21 CFR Part 860

00126 21 CFR Part 822 Postmarket Surveillance
  • Postmarket Surveillance
  • PMS

21 CFR Part 822 21 CFR Part 822

00125 21 CFR Part 821 Medical Device Tracking
  • medical device tracking
  • UDI

21 CFR Part 821 21 CFR Part 821

00124 Pre-Submission – Q-Sub
  • q-sub
  • pre-sub

Pre-Submission - Q-Sub Pre-Submission - Q-Sub

00123 Predicate Device – Substantially Equivalent
  • substantially equivalent

Predicate Device Predicate Device

21 CFR Part 814 Premarket Approval (PMA)
  • premarket approval
  • PMA

21 CFR Part 814 21 CFR Part 814

00121 21 CFR Pat 807-E Premarket Notification (510K)
  • premarket notification
  • 510K
  • PMN

21 CFR Part 807 21 CFR Part 807

00091 REV01 21 CFR Part 812 Investigational Device Exemptions
  • Investigational Device Exemptions

21 CFR Part 812 21 CFR Part 812

00092 21 CFR Part 806 Overview Reports of Corrections and Removals
  • Reports of Corrections & Removals

21 CFR Part 806 21 CFR Part 806

00093 21 CFR Part 801 Labeling (of Medical Devices)
  • Labeling
  • Labels

21 CFR Part 801 21 CFR Part 801

00114 2023 21 CFR 809 Proposed LDT Rule -Timeline

Proposed 2023 LDT Rule Proposed 2023 LDT Rule

PPT-00027 REV01 21 CFR Part 11
  • 21 CFR Part 11
  • electronic signatures
  • electronic records

21 CFR Part 11 21 CFR Part 11

00027 REV01 21 CFR Part 820
  • 21 CFR Part 820
  • QSR
  • GMP

21 CFR Part 820 21 CFR Part 820

00116 21 CFR Part 803 Medical Device Reporting
  • Medical Device Reporting

21 CFR Part 803 21 CFR Part 803

00119 21 CFR Part 809 IVDs for Human Use
  • IVD
  • label
  • labelling

21 CFR Part 809 21 CFR Part 809

00118 21 CFR Part 80 Federal Preemption and Exemptions
  • preemption
  • exemptions

21 CFR Part 808 21 CFR Part 808

00117 21 CFR Part 807 Establishment Registration & Listing
  • registration
  • listing

21 CFR Part 807 21 CFR Part 807

00120 21 CFR Part 810 Medical Device Recall Authority
  • recall authority
  • cease distribution order
  • mandatory recall order

21 CFR Part 810 21 CFR Part 810

00113 Traceability
  • traceability
  • identification

Traceability Traceability

00110 Cybersecurity in Medical Devices- TPLC Risk Management
  • TPLC
  • cybersecurity

Cybersecurity - TPLC Cybersecurity - TPLC

00109 Cybersecurity in Medical Devices- Security Risk Management Documentation
  • security risk management
  • cybersecurity

Cybersecurity Security Risk Management Documentation Cybersecurity Security Risk Management Documentation

00108 Cybersecurity in Medical Devices- Security Assessment of Unresolved Anomalies
  • anomalies
  • cybersecurity

Cybersecurity Unresolved Anomalies Cybersecurity Unresolved Anomalies

00107 Cybersecurity in Medical Devices- Documentation Supporting Software Bill of Materials
  • SBOM
  • cybersecurity
  • submission

Documentation of Software Bill of Materials Documentation of Software Bill of Materials

00106 Cybersecurity in Medical Devices- Software Bill of Materials
  • SBOM
  • cybersecurity

Software Bill of Materials Software Bill of Materials

00105 Cybersecurity in Medical Devices- 3rd Party Software Components
  • 3rd Party Software
  • cybersecurity

Cybersecurity - 3rd Party Software Components Cybersecurity - 3rd Party Software Components

00104 Cybersecurity in Medical Devices- Threat Modeling
  • threat modeling
  • cybersecurity

Cybersecurity Threat Modeling Cybersecurity Threat Modeling

00102 Cybersecurity in Medical Devices- Security Risk Management
  • security risk manamgent

Cybersecurity Security Risk Management Cybersecurity Security Risk Management

00101 Cybersecurity in Medical Devices- SPDF
  • SPDF
  • cybersecurity

Cybersecurity SPDF Cybersecurity SPDF

00100 Cybersecurity in Medical Devices- Submission Documentation
  • submission documents
  • cybersecurity

Cybersecurity Submission Documentation Cybersecurity Submission Documentation

00099 Cybersecurity in Medical Devices- Transparency
  • transparency
  • cybersecurity

Cybersecurity - Transparency Cybersecurity - Transparency

00098 Cybersecurity in Medical Devices- Designing for Security
  • cybersecurity
  • designing for security

Cybersecurity - Designing for Security Cybersecurity - Designing for Security

00097 Cybersecurity in Medical Devices- Design Control
  • cybersecurity
  • design control

Cybersecurity in Design Control Cybersecurity in Design Control

00096 Cybersecurity in Medical Devices- Background
  • medical device system
  • pre-sub

Cybersecurity in Medical Devices – Background Cybersecurity in Medical Devices – Background

00095 Cybersecurity in Medical Devices- Scope
  • scope
  • pre-sub

Cybersecurity in Medical Devices- Scope Cybersecurity in Medical Devices- Scope

00094 Cybersecurity in Medical Devices- Overview
  • cybersecurity threat

Cybersecurity in Medical Devices- Overview Cybersecurity in Medical Devices- Overview

00025 REV01 Code of Federal Regulations Description
  • CFR
  • regulation

Reading CFR Reading CFR

00090 VALID Act: Conditions of Approval and Approval Publication
  • VALID Act

Conditions of Approval and Approval Publication Conditions of Approval and Approval Publication

00088 VALID Act Amending An Application
  • VALID Act

Amending An Application Amending An Application

00071 Prognostic Biomarker

Prognostic Biomarker Prognostic Biomarker

00072 Predictive Biomarker

Predictive Biomarker Predictive Biomarker

00073 Safety Biomarker

Safety Biomarker Safety Biomarker

00074 Monitoring Biomarker

Monitoring Biomarker Monitoring Biomarker

00075 Response Biomarker

Response Biomarker Response Biomarker

00076 Pharmacodynamic (Response) Biomarker

Pharmacodynamic (Response) Biomarker Pharmacodynamic (Response) Biomarker

00077 Surrogate Endpoint (Response) Biomarker

Surrogate Endpoint (Response) Biomarker Surrogate Endpoint (Response) Biomarker

00085 VALID Act Pre-Market Review Application
  • VALID Act

VALID Act Pre-Market Review Application VALID Act Pre-Market Review Application

00089 VALID Act Approval Process Go-No-Go Factors
  • VALID Act

Approval Process Go-No-Go Factors Approval Process Go-No-Go Factors

00087 VALID Act Special Pre-Market Review

Special Pre-Market Review Special Pre-Market Review

00086 VALID Act Refused Or Deficient Application
  • VALID Act

00086 VALID Act Refused Or Deficient Application 00086 VALID Act Refused Or Deficient Application

00084 VALID Act Pre-Market Review Requirement
  • VALID Act

Pre-Market Review Requirement Pre-Market Review Requirement

00083 VALID Act General Laboratory Equipment Exemption
  • VALID Act
  • exemption

General Laboratory Equipment Exemption General Laboratory Equipment Exemption

00082 VALID Act Buying and Selling IVCTs and Notifications
  • VALID Act

Buying and Selling IVCTs and Notifications Buying and Selling IVCTs and Notifications

00081 VALID Act Investigational Use Exemption
  • exemption

Investigational Use Exemption Investigational Use Exemption

00080 VALID Act Modified Tests
  • VALID Act

Modified Tests Modified Tests

00079 VALID Act Parts and Components for Further Development
  • exemption

Parts and Components for Further Development Parts and Components for Further Development

00078 LDT Jurisdiction Debate

LDT Jurisdiction Debate LDT Jurisdiction Debate

00070 Diagnostic Biomarker

Diagnostic Biomarker Diagnostic Biomarker

00069 Susceptibility/Risk Biomarker

Susceptibility/Risk Biomarker Susceptibility/Risk Biomarker

00068 Biomarker Types by Disease Progress

Biomarker Types by Disease Progress Biomarker Types by Disease Progress

00067 Public Health Surveillance Exemption
  • Exemption

Public Health Surveillance Exemption Public Health Surveillance Exemption

00063 Manual Test Exemption

Manual Test Exemption Manual Test Exemption

00064 Humanitarian Test Exemption
  • humanitarian test exemption

Humanitarian Test Exemption Humanitarian Test Exemption

00065 Custom and Low-Volume Test Exemption

Custom & Low-Volume Test Exemption Custom & Low-Volume Test Exemption

00062 VALID Act: Near-Patient Testing Guidance
  • near-patient

Near-Patient Testing Guidance Near-Patient Testing Guidance

00066 Law Enforcement and Employer Testing Exemption
  • exemption

Law Enforcement and Employer Testing Exemption Law Enforcement and Employer Testing Exemption

00061 VALID Act: Grandfathered Tests
  • Grandfathered Tests

VALID Act: Grandfathered Tests VALID Act: Grandfathered Tests

00060 VALID Act Emergency Use Authorization
  • EUA in VALID Act

Emergency Use Authorization Emergency Use Authorization

00059 VALID ACT: DEVELOPER DISAGREEMENT ABOUT IVCT EXEMPTION
  • exemption disagreement

Developer Disagreement about IVCT Exemption Developer Disagreement about IVCT Exemption

00057 VALID Act- Applicability & Overlap with CLIA
00058 Breakthrough Devices
  • breakthrough
  • priority review

Breakthrough Devices Breakthrough Devices

00055 VALID Act: Well-Characterized
  • well-established
  • well-recognized

Well-Characterized Well-Characterized

00056 VALID Act: Interstate Commerce
  • interstate
  • commerce
  • in vitro clinical test

Interstate Commerce Interstate Commerce

00054 VALID Act-  Specimen Receptacle
  • specimen receptacle

Specimen Receptacle Specimen Receptacle

00053 VALID Act: Cross-Referenced Test
  • cross-referenced
  • medical products

Cross-Referenced Test Cross-Referenced Test

00052 VALID Act: Valid Scientific Evidence
  • Scientific Evidence

Valid Scientific Evidence Valid Scientific Evidence

00051 VALID Act: IVCT Technology
  • Technology

IVCT Technology IVCT Technology

00050 VALID Act: Instrument and Instrument Family
  • Instrument Family
  • VALIID Act

Instrument and Instrument Family Instrument and Instrument Family

00049 VALID Act: Developer vs Laboratory Operations
  • Developer
  • Laboratory Operations

Developer vs Laboratory Operations Developer vs Laboratory Operations

00048 VALID Act Low-Risk vs. High-Risk IVCT
  • IVCT Risk Classification

Low-Risk vs. High-Risk IVCT Low-Risk vs. High-Risk IVCT

00045 REV01 VALID Act: Overview
  • VALID Act
  • IVCT
  • FD&C Section 587

VALID Act: Overview VALID Act: Overview

00046 VALID Act First-Of-A-Kind
  • First-of-a-kind
  • IVCT

First-Of-A-Kind IVCT First-Of-A-Kind IVCT

00046 VALID Act: IVCT Definition
  • IVCT definition

IVCT Definition IVCT Definition

00044 Non-Significant Administrative Changes for MDR-IVDR
  • admin changes
  • non-significant

Non-Significant Administrative Changes for MDR-IVDR Non-Significant Administrative Changes for MDR-IVDR

00043 EMDN Nomenclature Hierarchy & Example
  • EMDN
  • CDN

EMDN Nomenclature Hierarchy & Example EMDN Nomenclature Hierarchy & Example

00042 GMDN-CDN-EMDN
  • GMDN
  • EMDN
  • CDN

Nomenclature Nomenclature

00041 Considerations for the Development of CAR T Cell Products
  • CAR T Cell
  • Development
  • FDA Draft Guidance

CAR T Cell Development CAR T Cell Development

00040 CAPA Management
  • CAPA

CAPA Management CAPA Management

00038 Criteria for Determining SaMD Category
  • SaMD Category

Criteria for Determining SaMD Category Criteria for Determining SaMD Category

00037 QA vs QC
  • quality assurance
  • quality control

QA vs QC QA vs QC

00036 IVD vs LDT vs CTA vs Investigational Product
  • investigational product
  • LDT
  • CTA

IVD vs LDT vs CTA vs Investigational Product IVD vs LDT vs CTA vs Investigational Product

00035 Investigational Device Types
  • Investigational IVD
  • 21 CFR Part 812
  • IDE

Investigational IVD Types Investigational IVD Types

00034 Companion Diagnostic
  • companion diagnostic

Companion Diagnostic Companion Diagnostic

00033 Codevelopment
  • codevelopment
  • companion diagnostics

Codevelopment Codevelopment

00032 Combination Product Types
  • combination product types

Combination Product Types Combination Product Types

00031 Combination Product
  • combination product

Combination Product Combination Product

00029 REV01 State of the Art

State of the Art State of the Art

00021 REV01 ISO 14971-2019 Risk Management Process Overview
  • ISO 19471:2019
  • risk management
  • risk process

14971-2019 Risk Management Process Overview 14971-2019 Risk Management Process Overview

00011 REV01 NextSeq 550
  • NextSeq
  • instrument
  • sequencer

NextSeq 550 NextSeq 550

00026 REV01 IVD Manufacturers
  • manufacturers
  • IVD

IVD Manufacturers IVD Manufacturers

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