Transcript Slide 1

The FDA Landscape
AdvaMed September 2008
Judith K. Meritz
[email protected]
FDA Mission
• “The FDA is responsible for protecting the public
health by assuring the safety, efficacy and security
of human and veterinary drugs, biological products,
medical devices, our nations' food supply,
cosmetics, and products that emit radiation. The
FDA is also responsible for advancing the public
health by helping to speed innovations that make
medicines and foods more effective, safer and more
affordable; and helping the public get the accurate,
science-based information they need to use
medicines and foods to improve their health.”
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FDA Regulatory Authority
• Laws
Published in United States Code (USC)
Federal Food, Drug and Cosmetic Act
Public Health Service Act
Radiation Safety and Health Act
Safe Medical Devices Act
• Regulations
Comments
Published in Code of Federal Regulations
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FDA Regulatory Authority
• Food and Drug Act of 1906.
Prohibits shipment of adulterated or misbranded
food or drugs in interstate commerce. DEVICES NOT
INCLUDED
• Food, Drug and Cosmetic Act of 1938.
Device adulteration and misbranding prohibited and
inspection and rulemaking authority added… (also
premarket approval for new drugs)
• Radiation Control for Health and Safety Act of 1968
Standards for radiation emitting devices (x-ray)
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FDA Regulatory Authority
• Medical Device Amendments of 1976
Premarket approval devices, GMP’s and Post
Market Controls (Registration Listing) (Reporting to
FDA of deaths/serious injuries – MDR)
• Safe Medical Devices Act of 1990 (SMDA)
Substantial equivalence for 510(k)
FDA post-market regulation/enforcement
Device tracking; civil penalties
Reports removals corrections/ recalls
User facilities to report deaths, serious injuries
and serious illnesses to FDA
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FDA Regulatory Authority
• Food and Drug Administration Modernization Act of
1997 (FDAMA)
Streamline Premarket Review
Limit device tracking and post-market surveillance
requirements
• Medical Device User Fee and Modernization Act of
2002 (MDUFMA)
• Food and Drug Administration Amendments Act of
2007 (FDAAA)
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Structure of FDA
• FDA part of US Government
• Office of the Commissioner
• Product Specific Centers
Drug Evaluation and Research (CDER)
Biologics Evaluation and Research (CBER)
Devices and Radiological Health (CDRH)
Food Safety and Applied Nutrition (CFSAN)
Veterinary Medicine (CVM)
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Device Basics
• Establishment Listing
• Device Listing
• 510(k)
• PMA
• Quality System
• Labeling Requirements
• Medical Device Reporting
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Definition of Medical Device
•An “instrument, apparatus, implement,
machine, contrivance, implant, in vivo
reagent…including any component, part or
accessory”
WHICH IS
intended for use in the diagnosis or treatment
of a disease or condition OR
Intended to affect the structure or function of
the body
AND
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Definition of Medical Device
Which does not achieve any of its primary
intended purposes through chemical action
within the body
AND
Which is not dependent on being metabolized
for the achievement of any of its primary
intended purposes
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Device Classification
• Completed in 1970’s through FDA rulemaking with
input from advisory panels
• Classification lists are in 21 CFR Part 800
Medical Device Classification
CLASS I
CLASS II
CLASS III
Low Risk
Moderate Risk
High Risk
General Controls
General Controls
General Controls
Special Controls
PMA
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Medical Devices Licensed as
Biologics or by Drug Center
• Some devices proceed through different
pathways and are reviewed by CBER not
CDRH
Generally in vitro diagnostic devices used to
test blood supply; some cell and tissue
products [test kits to test for blood type or HIV]
Devices for blood collection
• Devices that are considered biologics
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Combination Products
• Need to determine which product application to
submit and which FDA center will have primary
review responsibility
• Decision based on primary mode of action
• Addressed in FDA Intercenter Agreements
• Sponsor may submit a “Request for Designation”
• FDA Office of Combination Products established
in December 2002
• Examples: drug-eluting coronary stent or antibiotic
bone cement
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Paths to Market
• Class I devices generally exempt from pre-market
clearance by FDA
• 510(K) clearance from FDA – show that class II
device you want to market is “substantially
equivalent” to another marketed device. SE
comparison based on intended use, materials,
performance.
• PMA (Pre-Market Approval application) approved by
FDA – show that class III device has reasonable
assurance of safety & efficacy. Requires clinical
testing data from humans.
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Registration
• Who must Register
• Device
Manufacturers
• Contract
Manufacturers
• Component
Manufacturers
• Accessory
Manufacturers
• Contract
Sterilizers
• Initial Importer
• Foreign
Establishments
• Repackagers
and Relabelers
• Processors of
Single use
Devices
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Registration
• Who does not register?
• Manufacturers of Raw Materials
• Manufacturers of general purpose articles (e.g.
chemical reagents) not labeled/ promoted medical
use
• Licensed health care practitioners who manufacture
a device solely for use in practice
• Pharmacies that sell or deliver to ultimate user
• Wholesale distributors
• Carriers (e.g. UPS, FED Ex)
• Manufacturers of devices intended solely for
research, teaching or analysis and which are not
commercially distributed
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Registration
• How and when to Register
• FDA forms for initial registration
Within 30 days of beginning activity
Annual registrations
• Electronically
• “Official” correspondent designated to register
and keep records
• “US Agent” for foreign establishments
•Prior to exporting devices to U.S.
• Within 30 days of charge in ownership,
establishment name, official correspondent or
address
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Device Listing Registration
• Listing - Must File list of devices company has placed in
commercial distribution
• Who, What, When
• Same entities who register, except:
•Contract manufacturers; Contract
Sterilizers
•Initial importers
• FDA forms electronically
• List devices when initial registration is completed
•Annually between 10/1 and 12/31
•Must update listing
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