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The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services. 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.

 To

evaluate compliance with the following FDA device regulations: Quality Systems Medical Device Reporting Medical Device Tracking Reports of Corrections and Removals Registration and Listing
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 Device

manufacturers that:
class III devices

Make Make

implantable devices and life supporting and life sustaining devices introduced a new device to the market

Recently Have

had significant violations in the

past
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 FDA

calls domestic manufacturers about 5 days before the inspection

contacts foreign manufacturers 2 - 3 months in advance to schedule inspection is requested to send Quality System Manual or equivalent for pre-inspection review
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FDA

Manufacturer

The

FDA investigator will:

to see the top management

Ask

Present Issue

credentials (identifies person as an FDA investigator) notice of inspection explaining FDAs legal authority to inspect (only in the U.S.)
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 Investigator

may tour the facility to get an idea of layout, workflow, and areas that may need closer inspection

This

helps the investigator decide how to organize the inspection

The

investigator will:

Ask

about size and structure of company, who is in charge, what products are manufactured there registration and listing compliance with FDA regulations using the Quality System Inspection Technique (QSIT)
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Review

Evaluate

 Identifies

4 major subsystems to evaluate and states the purpose and importance of each subsystem flowcharts and inspectional objectives to cover during inspection
advice tables for statistical sampling of records for review
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Provides
Offers

Provides

Design Controls

Corrective & Preventive Actions

Production & Process Controls

Management Material Controls Equipment & Facility Controls

Records, Documents, & Change Controls

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 Quality

Policy established?
representative

Management

appointed?

Management
Quality

reviews conducted?

audit procedures established and quality audits conducted?

Quality
Quality

plan established?

system procedures established?

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Office of the Center Director

Office of Device Evaluation

Office of In Vitro Diagnostic Device Evaluation & Safety

Office of Compliance

Office of Surveillance & Biometrics

Office of Science & Technology

Office of Systems & Management

Office of Health & Industry Programs

Division of Small Manufacturers, International & Consumer Assistance

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Division of Enforcement A

Division of Enforcement B

Dental, ENT & Ophthalmic Devices

OB/GYN, Gastro & Urology Devices General Hospital Devices General Surgery Devices

Cardiovascular & Neurological Devices

Diagnostic X-ray Devices

Electronic Products & Devices

Orthopedic, Physical Medicine & Anesthesiology Devices

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 Send

a letter to FDA identifying how they have corrected deficiencies or will correct them documentation of any corrections that have been completed a timetable or estimated completion date for future corrections
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Provide

Provide

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