cr ppt.pptx
TRANSCRIPT
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CFSAN & CDRH
13thSeptember 2013
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Introduction: FDA
The Food and drug administration (FDA) is an agencyof United States department of health and human
services, one of the United States federal executive
departments
The FDA is responsible for protecting and promotingpublic health through the regulation and supervision
of food safety, tobacco products, dietary supplements
prescriptionand over-the-counterpharmaceutical
drugs (medications), vaccines, biopharmaceuticalsblood transfusions, medical devices, electromagnetic
radiation emitting devices (ERED), and veterinary
products
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Agenda Center for Food Safety and Applied Nutrition
Introduction
Mission Statement
Organization of CFSAN
Key focus areas of CFSAN
Major responsibilities Centre for Devices and Radiological Health
Introduction
Mission Statement
Organization of CDRH
Classification of devices
Key controls
Major challenges
Reporting Programs
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Center for Food Safety and Applied
Nutrition (CFSAN)13thSeptember 2013
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Introduction: CFSAN
The Center for Food Safety and Applied Nutrition(CFSAN) is the branch of FDA that regulates food, dietarysupplementsand cosmetics
CFSAN was Established in April 1996, and has over 800employees ranging from secretaries & other support staff
to highly specialized professionals
CFSAN is responsible for food labeling, specifically the"Nutrition Facts & Ingredient declarationspaneltypically seen on packaged foods.
Shared responsibility with the U.S. Department ofAgricultures Food Safety and Inspection Service are; Meat (with the exception of seafood & some exotic meats)
Eggs.
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Mission Statement
CFSAN is responsible for promoting and protecting thepublic health by ensuring that the nation's food supply is
safe, sanitary, wholesome, and honestly labeled, and that
cosmetic products are safe and properly labeled.
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Organization of CFSAN
Rather than being a rigidly centralized organizationthey separated their various tasks and assigned each to
a designated office.
Office of Food Labeling
Office of Seafood Office of Cosmetics and Colors
Office of Plant and Dairy Foods and Beverages
Office of Special Nutritionals
Office of Special Research Skills and Support
Office of Premarket Approval
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Key focus areas of CFSAN
Biological Pathogens
Dietary Supplements
Toxic Metals
Food allergens
Nutrient Concerns Pesticide residue
Naturally occurring toxins
Decomposition and Filth
Dietary Components
Radio nuclides
Product tampering
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Major responsibilities
Five major responsibilities includes; Monitor substances added to food (ionizing radiation, colour
additives) for safety
Assure no harmful products results through processes of
bioengineered foods ( allergens, toxicants) Regulate the proper labeling of food, cosmetics and their
ingredients
Regulate policies governing the safety of dietary
supplements, infant formulas and medical foods Consumer education and industry outreach
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Center for Devices and
Radiological Health13thSeptember 2013
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Introduction: CDRH
A medical device is defined as any healthcare productthat does not achieve its principal intended purposes by
chemical action or by being metabolized.
It may involve;
As simple as a tongue depressor or a thermometer As complex robotic surgery devices
Devices have become more complex due to
advancement in;
Electronic technologies
Synthetic organs/tissues & combination products
Detection, diagnostic, & monitoring technologies etc.
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Mission Statement
Get safe and effective devices to market as quickly aspossible.
Ensure that devices currently on the market remain safe
and effective.
Help the public get science-based accurate informationabout medical devices and radiological products needed to
improve health.
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Organization of CDRH
Office of center director Office of compliance
Office of device evaluation
Office of management operations
Office of Surveillance & Biometrics
Office of Communication, Education, &Radiation
Programs
Office of In Vitro Diagnostic Device Evaluation & Safety Office of Science & Engineering Laboratories
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Classification of devices
General Controls
Most exempt from premarketsubmission
Class I
Special Controls
Premarket NotificationClass II
Premarket ApprovalClass III
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CDRH controls Contd
General Controls Register and list
Follow good manufacturing practices
Report device failures
Corrective Action Plans Labeling requirements
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CDRH controls
Special Controls Guidelines/Guidance
Design control
Performance data
Tracking requirements Labeling requirements
Post market surveillance
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CDRH Major Challenges
Globalization Getting new, innovative and complex technologies to
market
Assuring postmarket safety
Meeting health and safety threats
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CDRH Reporting Programs
VoluntaryMedWatch Reporting by healthcare professionals and consumers
Report actual or potential product problems
Mandatory
User Facilities Reportdeaths and serious injuries
Manufacturers
Report deaths, serious injuries, and malfunctions
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Thank You