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Presentation: Evaluating Breakthrough Technology: An FDA Perspective

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

June 15, 2001

What are Breakthrough Technologies?

Fast Track Products

Food Drug & Cosmetic Act

• Amended by the FDA Modernization Act of 1997 to include section 506: Fast Track Products

Two Qualifying Criteria:

• Intended to treat a serious or life- threatening condition
• Potential to address unmet medical needs for the condition

Treatment of Serious Conditions:

Examples

• a therapy directed at serious symptoms or serious manifestations of the condition;
• a diagnostic evaluated for the impact on a serious aspect of the condition;
• a preventive intended to prevent a serious aspect;
• a product which could ameliorate serious adverse effects of other treatments.

Address Unmet Medical Needs

Examples

• no existing therapy
• new therapy is better
• new therapy for patients intolerant orunresponsive to existing therapy
• new therapy is less toxic
• new therapy improves compliance (which is shown to improve effects on serious conditions)

How do breakthrough products get to Market ?

Fast Track Products

Food Drug & Cosmetic Act

• Amended by the FDA Modernization Act of 1997 to include section 506: Fast Track Products
• Authorizes FDA to:
  • Facilitate Development
  • Expedite Review

   

(A diagram of a red arrow marked Premarket connecting to a green arrow marked Postmarket. Below the red arrow, the word 'evidence' scales up from small to large horizontally.)

CDRH Vision - Total Product Life Cycle

(Picture of the Strategic Plan Logo, which is a spiral of interconnected colored arrows. The arrows from the top and clockwise read: Concept, Prototype, Preclinical, Clinical, Manufacturing, Marketing, Commercial Use, and Obsolescence.)

(Strategic Plan Logo, surrounded by the following words clockwise from the top: Engineering, Mode of Action, Clinical Sciences, Quality Systems, Post-marketing Surveillance, End of Life, Design.)

(Strategic Plan Logo, surrounded by the following words clockwise from the top: Device Advice, Early Planning Meetings, IDEs, Agreement & Determination Meetings, Guidance, PMA's, 510(k)s, Advisory Panels, MDR's, Post-Marketing Studies, Warning Letters, Safety Alerts, Recalls, Request for Designation.)

CDRH Vision - Total Product Life Cycle

(Picture of a series of Strategic Plan Logos in a row)

The Pipeline

New Technologies

Issues

• Regulatory Path:
  • Drug?
  • Biological?
  • Device?
• Combination Products
  • Which Center Leads?
  • How to accelerate development?

Acceleration: Options

Intensify
Telescope
Combine
Shorten
Simplify
Skip
Postpone

Acceleration: Options

Intensify (word is greyed out)
Telescope (word is greyed out)
Combine (word is greyed out)
Shorten
Simplify
Skip
Postpone

(Next to the colored words is written "Lower Standards?")