Topic - Investigational Device Exemption (IDE) and In Vitro Diagnostics (IVD), quality system requirements (21 CFR part 820), labeling requirements (21CFR part 801)  An IDE is a regulatory submission to the FDA that permits the clinical investigation of devices.What is IDE ( Investigational Device Exemption )- An Investigational Device Exemption (IDE) is an authorization from the FDA that allows an investigational device to be used in a clinical study to collect safety and effectiveness dataIDEs are governed by 21 CFR Part 812, which outlines the procedures for conducting clinical studies on unapproved devices. IDE should be sent to – Food and Drug Administration Center for Devices and Radiological Health(CDRH) Document Mail center- WO66-G609 10903 New Hampshire Avenue Sliver Spring, Maryland 20993-002 In Vitro Diagnostics (IVD),It is an instrument, apparatus, implement, machine, implant, in vitro reagent, or other similar or related article intended for use in the diagnosis of disease or in cure, mitigation, treatment, or prevention of disease. 21CFR Part 820- Quality Management System What is a Quality Management System? A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization’s purpose and strategic direction. Labeling regulations pertaining to medical devices are found in the following parts of Title 21 of the code of federal regulation. General device labelling ; 21CFR part 801 In vitro device (IVD) labeling; 21 CFR part 809Risk-based classification of IVDs Acc. To FDA Each IVD is assigned to one of three risk-based regulatory classes, Class I, Class II, or Class III, based on the level of regulatory control necessary to provide reasonable assurance of its safety and effectiveness. Quality System RequirementsWhat is IDE ( Investigational Device Exemption )- An Investigational Device Exemption (IDE) is an authorization from the FDA that allows an investigational device to be used in a clinical study to collect safety and effectiveness dataIDEs are governed by 21 CFR Part 812, which outlines the procedures for conducting clinical studies on unapproved devices. Food and Drug Administration Center for Devices and Radiological Health(CDRH) Document Mail center- WO66-G609 10903 New Hampshire Avenue Sliver Spring, Maryland 20993-002 It is an instrument, apparatus, implement, machine, implant, in vitro reagent, or other similar or related article intended for use in the diagnosis of disease or in cure, mitigation, treatment, or prevention of disease. Investigational device exemptions(IDE); 21 CFR 812 Labeling requirements; types of submissions510k – 21 CFR 807.87(e) IDE- 21 CFR 812.5 PMA- 21 CFR 814.20(b)(10) In-vitro Diagnostics- 21 CFR 809.10 Must be included on the package label Name and place of manufacturer, packer or distributor.Acc. To USFDA minimal labelling requirements.

1. Topic - Investigational Device Exemption (IDE)
and In Vitro Diagnostics (IVD), quality system
requirements, 21 CFR part 820, labeling
requirements, 21CFR part 801

2. Investiga
tional
Device
Exemption
(IDE)
• IDE is a regulatory
pathway allowing
clinical investigation
of medical devices
before market approval.

4. In Vitro
Diagnostics
(IVD)
• IVD refers to tests
performed on bodily
samples, providing
crucial information for
disease diagnosis and
treatment.

5. Quality
System
Requireme
nts
• Ensuring compliance
with quality standards
is vital for the
development and
manufacturing of
medical devices.

6. Regulatory Compliance
• Adherence to regulatory standards is essential
to ensure safety, efficacy, and quality of
medical devices.

7. Conclusion
• Understanding IDE and IVD quality
system requirements is crucial
for successful medical device
development and approval.