FDA and Federal Law: Background and Implementation

1
FDA and Federal Law Background and Implementation

• Don St.Pierre
• Deputy Director for Premarket Evaluation
• Office of In Vitro Diagnostic Device Evaluation
  and Safety
• Center for Devices and Radiological Health

2
Background U.S Constitution

• Separation of Powers Doctrine for the Federal
  Government
• Legislative (Congress)
• Executive (President)
• Judicial (Supreme Court)

3
FDA Regulation

• Congress writes statutes. Statutes are the US
  governments legal authority.
• FDA (The Executive Branch of government) writes
  regulations to implement the statute. Firms must
  comply with the statute and regulations (federal
  law).
• FDA writes guidance documents to explain its
  thinking on legal requirements but guidance is
  not enforceable like the laws.

4
Making Regulations

• How to make a law
• Administrative Procedure Act establishes rules
  for making new regulations. It lets the public
  participate (comment) on new regulations.
• The Federal Register serves as the US
  Governments publication (like a newspaper) to
  announce whats happening, such as
• public meetings,
• request for comments on new regulations,
• availability of certain information.

5
Your place in the Government

• Federal regulations are executive branch laws.
• Government employees perform the work.
• Department of Health and Human Services
• -- Public Health Service
• -- Food and Drug Administration
  (Commissioner)

6
Federal Regulation of Devices

• Other federal agencies laws affect products
  regulated by FDA laws. For example
• Environment (EPA)
• US Customs / Money (Treasury)
• Law Enforcement (Dept. of Justice)
• Crops and animals (Dept. of Agriculture)
• Advertising (Federal Trade Commission)
• International Trade (Dept. of Commerce)

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FDA is a Public Health Enforcement Agency

• Authority for FDA regulations
• Statute
• Food, Drug, and Cosmetic Act, as amended.
  (Scores of amendments)
• Regulations for general procedures and for
  specific product areas (Centers)
• For example
• CDRHs Regulations --
• Title 21 Code of Federal Regulations (CFR) Parts
  800 to 1271.

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CDRHs Legislative Mandates

• 1968 Radiation Control for Health Safety Act
  (RCHSA)
• 1976 Medical Device Amendment of 1976
• 1988 Clinical Laboratory Improvement Amendments
  (CLIA)
• 1990 Safe Medical Devices Act (SMDA)
• 1992 Mammography Quality Standards Act (MQSA)
• 1992 Medical Device Amendments
• 1997 Food Drug Administration Modernization
  Act (FDAMA)
• 2002 Medical Device User Fee and Modernization
  Act (MDUFMA)
• Medical Device User Fee Stabilization Act
  (MDUFSA)
• 2007 Food and Drug Administration Amendments Act
  of 2007 (FDAAA)

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FDAs Implementation of Law

• FDA areas that implement the law.
• Commissioner
• Operations / Science / Regulatory / Policy /
  Intl / Legal
• Five Centers
• Food (CFSAN)
• Drugs (CDER)
• Veterinary Med (CVM),
• Biologics (CBER)
• Devices and Radiological Health (CDRH)
• Office of Regulatory Affairs

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FDA Regulation of Devices

• Chapter V of the FDC Act Devices ( Drugs)
• Register with FDA
• Premarket - OK by CDRH to market
• Premarket Notification, 510(k) (Class II)
• Premarket Approval Application, PMA (Class III)
• Postmarket regulatory obligations
• Adulteration Charges dont do bad things with
  it.
• Misbranding Charges dont say bad things about
  it.

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FDA Regulation of Devices

• Other FDA legal issues in the statute, for
  example
• Definitions (a device 201(h))
• Prohibited Acts and Penalties Chapter III
• General Authority. E.g., inspections, Ch. VIII
• Imports and Exports Chapter VIII

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FDAs Mission

• Protect public health
• Promote public health
• Collaborate with other countries
• Collaborate with scientific experts, academia,
  industry and consumers

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FDA Organization
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CDRH Mission
Get safe and effective medical devices to market
as quickly as possible
while ensuring that medical devices currently
on the market remain safe and effective.
Risks
Benefits
Help the public get science-based accurate
information about medical devices and
radiological products needed to improve health.
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CDRHs Organizational Chart
Office of the Center Director Jeffrey Shuren,
M.D., JD, Director (Acting) Lillian Gill, D.P.A.,
Senior Associate Director Vacant, Associate
Director for Regulations and Policy Jonathan
Sackner-Bernstein, M.D., Associate Director for
Postmarket Operations Ruth McKee, Associate
Director for Management
CDRH Ombudsman Les Weinstein, J.D.
Office of Compliance Timothy A. Ulatowski
Office of Surveillance Biometrics Susan N.
Gardner, Ph.D.
Office of Management Operations Frank Benedetti
Office of Device Evaluation Donna-Bea Tillman,
Ph.D.
Office of Communication, Education, Radiation
Programs Lynne L. Rice
Office of In Vitro Diagnostic Device Evaluation
Safety Alberto Gutierrez, PhD
Office of Science Engineering
Laboratories Steve Pollack, PhD
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THANK YOU

• Don St.Pierre
• 301-796-5454
• don.st.pierre_at_fda.hhs.gov