CFSAN & CDRH

13th September 2013

Introduction: FDA

The Food and drug administration (FDA) is an agency of United States department of health and human services, one of the United States federal executive departments The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), and veterinary products

Agenda

Center for Food Safety and Applied Nutrition

Introduction Mission Statement Organization of CFSAN Key focus areas of CFSAN Major responsibilities Introduction Mission Statement Organization of CDRH Classification of devices Key controls Major challenges Reporting Programs

Centre for Devices and Radiological Health

Center for Food Safety and Applied Nutrition (CFSAN)

13th September 2013

Introduction: CFSAN

The Center for Food Safety and Applied Nutrition (CFSAN) is the branch of FDA that regulates food, dietary supplements and cosmetics CFSAN was Established in April 1996, and has over 800 employees ranging from secretaries & other support staff to highly specialized professionals CFSAN is responsible for food labeling, specifically the "Nutrition Facts & Ingredient declarations panel typically seen on packaged foods. Shared responsibility with the U.S. Department of Agricultures Food Safety and Inspection Service are;

Meat (with the exception of seafood & some exotic meats) Eggs.

Mission Statement

CFSAN is responsible for promoting and protecting the public 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.

Organization of CFSAN

Rather than being a rigidly centralized organization they 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

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

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

Center for Devices and Radiological Health

13th September 2013

Introduction: CDRH

A medical device is defined as any healthcare product that 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.

Mission Statement

Get safe and effective devices to market as quickly as possible. Ensure that devices currently on the market remain safe and effective. Help the public get science-based accurate information about medical devices and radiological products needed to improve health.

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

Classification of devices

Class I

General Controls Most exempt from premarket submission Special Controls Premarket Notification

Class II
Class III

Premarket Approval

CDRH controls

Contd

General Controls

Register and list Follow good manufacturing practices Report device failures Corrective Action Plans Labeling requirements

CDRH controls

Special Controls

Guidelines/Guidance Design control Performance data Tracking requirements Labeling requirements Post market surveillance

CDRH Major Challenges

Globalization Getting new, innovative and complex technologies to market Assuring postmarket safety Meeting health and safety threats

CDRH Reporting Programs

Voluntary MedWatch

Reporting by healthcare professionals and consumers Report actual or potential product problems User Facilities

Mandatory

Report deaths and serious injuries

Report deaths, serious injuries, and malfunctions

Manufacturers

Thank You