CR ppt.pptx

8/14/2019 CR ppt.pptx

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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

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CR ppt.pptx