Biotech Primer Institute

Diagnostic Development & Approval

21 STUDENTS ENROLLED

Course Availability: Unlimited views for 72 hours from time of purchase
Course Running Time:
50 minutes | Assessment: 20 minutes
Course Material: Downloadable PDF of all presented slides
Preview Now: Regulation of New Clinical Tests

Diagnostic Development & Approval describes the regulatory pathways for different categories of diagnostics, emphasizing the differences between in vitro diagnostics and laboratory-developed tests. Quality system regulations are extensively reviewed.  The course ends with a discussion on methods for technology and economic evaluation of new diagnostics. This course helps expand your diagnostics development acumen.
Running time: 50 minutes | Assessment: 20 minutes

Diagnostics: Regulation of New Clinical Tests
At the end of this section you should be able to:
1. Summarize the regulatory pathway for different categories of diagnostics
2. Contrast In Vitro Diagnostics (IVD) and Laboratory Developed Tests (LDT)
3. Contrast oversight from Center for Medicare and Medicaid Services (CMS) with Food and Drug Administration (FDA)

Approval Process for Laboratory Developed Tests (LDT)
At the end of this section you should be able to:
1. Compare and contrast the regulatory differences between diagnostics developed via LDT and IVD
2. Explain the regulatory approval process for LDT diagnostics

Diagnostic Regulatory Pathways
At the end of this section you should be able to:
1. List the regulatory burden of Class I, II, III diagnostics
2. Assess a diagnostics category as Class I, II, III based on a diagnostic’s risk profile
3. Differentiate between a 510(k), De Nova 510(k), and Premarket Approval (PMA) regulatory pathways
4. Outline the general FDA submission requirements for IVD

Quality Control of Diagnostics
At the end of this section you should be able to:
1. Apply the Quality System Regulations (QSRs)

European Union Approval Pathways for Diagnostics
At the end of this section you should be able to:
1. Give a synopsis of the EU diagnostic approval process

Reimbursement for Diagnostics
At the end of this section you should be able to:
1. Describe methods for technology and economic evaluation of new diagnostics
2. Explain the mechanisms for diagnostic testing reimbursement
3. Define standard reimbursement codes

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