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Total Product Life Cycle

David W. Feigal, M.D., M.P.H.
Director, Center for Devices and
Radiological Health, FDA

The Computer Age

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Innovation and Trust

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How Does the US Provide the FDA’s Consumer Protection with such rapid innovation ?

Device Innovation:

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What Consumer Protections

regulatory burdens

are required to bring new products to market?

FDA Consumer Protection

Basic Responsibilities

• Risk Management

• First human use (IND or IDE)
• Safe experimental use (product development)
• Widespread use (market approval)
• Adverse Experience Evaluation

• Integrity assurance

• Enforcement

• Fraud
• Bad Manufacturing Practices
• Bad Clinical Practices

• Science-Based Regulatory Decisions

• Evidence Based; Standards

Product Life Cycle

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Consumer Protection

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Center for Devices and Radiological Health

Mission:

CDRH promotes and protects the health of the public by ensuring the safety and effectiveness
of medical devices and the safety of radiological products.

Center for Devices and Radiological Health

Vision:

Ensuring the health of the public throughout the

Total Product Life Cycle
-it's everybody's business

Strategic Goal Areas

• Public Health Impact
  (Meaningful Metrics)
• Total Product Life cycle
• Knowledge Management
• Magnet for Excellence

Principle: Goal areas to pursue "rich or poor"

Early Product Life Cycle

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• What is the product?

• Device, Pharmaceutical, Biological ?
• Combination product

• What makes the product new?

• biomaterials ?
• design?
• Indication?

• Are there critical performance specifications?

Early Product Life Cycle

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• Toxicology / Immunogenicity

• What is already known ?
• Does the product leech ? Oxidize ?
• Standards: ISO, CDER, CBER, CDRH
• Limitations of oral exposure models

Mid Product Life Cycle

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• Clinical Evaluation

• With final manufactured product or prototype ?
• Least burdensome source of clinical evidence ?

• Controls
• Questions to be left for postmarketing period ?

Mid Product Life Cycle

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• Full Scale Manufacturing

• Know your supplier

• Can you detect changes in components

• Know your consignee’s

• dialysis unintended use

• Liability

Late Procuct Life Cycle

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• End-of-Life Problems

• Customer complaints
• User Errors
• Product Failures

• Failure analysis

CDRH Vision - Total Product Life Cycle

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CDRH Vision - Total Product Life Cycle

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Cross-Generations

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CDRH Vision - Total Product Life Cycle

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Regulatory Cycle

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Science Cycle

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Pre-IDE Meetings

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Ad Hoc "ECG Lead off alarm"

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Deep Brain Stimulator

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Cell Phone EMC and Pacemakers

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Cochlear Implant

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External Defibrillators Battery Failures

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What’s it like to be an FDA Reviewer ?

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Forces for Change

Stakeholders

• Grass Roots: efficient, accountable,
• MDUFMA: efficient, accountable, change

Executive Branch

• President’s Management Agenda

• Performance Contracts: accountable
• Outsourcing, delayering, consolidating: efficient

• Office of Management and Budget

• GPRA, PART: accountable, change

• HHS / Commissioner / Chief Counsel

• One HHS: change
• Outcome and Risk based regulation: change
• Legally sufficient regulation: change

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Updated February 11, 2004

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