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U.S. Food and Drug Administration


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United states food and drug administration(usfda):

United states food and drug administration( usfda ) Presented By Alok kr vishwakarma Mahendra singh Bipin katiyar Amit verma M.pharm(pharmaceutics)

The U.S. Food and Drug Administration is:

The U.S. Food and Drug Administration is Scientific, Regulatory, Public Health Agency Mission is to protect and promote public health Authority to regulate medical devices Federal FD&C Act Established regulatory controls for medical devices (May 28, 1976) 2

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one of the United States federal executive departments , 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), veterinary products , and cosmetics .

Basic Mission:

Basic Mission Safety Efficacy Drugs Medical Devices Truthful Labeling Adulteration Misbranding


Organization Center for Biologics Evaluation and Research Center for Devices and Radiological Health , Center for Drug Evaluation and Research Center for Food Safety and Applied Nutrition Center for Tobacco Products Center for Veterinary Medicine National Center for Toxicological Research Office of Regulatory Affairs Office of the Commissioner

FDA Centers and Regulated Products:

FDA Centers and Regulated Products Food Drugs Medical Devices * Biologics Animal Feed and Drugs Cosmetics Radiation-Emitting Products * Combination Products ( drug-device * , biologic-device * , drug-biologic) 6 *

Inspections and legal sanctions:

Inspections and legal sanctions : FDA investigators and inspectors collect domestic and imported product samples for scientific examination and for label checks. If a company is found violating a law that FDA enforces, FDA can encourage the firm to voluntarily correct the problem or to recall a faulty product from the market. When a company can't (or won't) correct a public health problem with one of its products voluntarily, FDA has legal sanctions it can bring to bear. FDA can go to court to force a company to stop selling a product and to have items already produced seized and destroyed. When warranted, criminal penalties--including prison sentences--are sought against manufacturers and distributors.

Product recalls::

Product recalls: About 3,000 products a year are found to be unfit for consumers and are withdrawn from the marketplace, either by voluntary recall or by court-ordered seizure. In addition, about 30,000 import shipments a year are detained at the port of entry because the goods appear unacceptable

Investigational studies:

Investigational studies Biologics IND- Investigational new drug application Drugs IND- Investigational new drug application DEVICES IDE- Investigational devices exeptions COMBINATION PRODUCTS

Examples of Device Classes:

Examples of Device Classes Medical Device Classes: Class I General Controls Most exempt from premarket submission Class II Special Controls Premarket Notification [510(k)] Class III Require Premarket Approval [PMA] 10

Clinical Trials:

Clinical Trials Phase I What are the side effects? Is it safe enough to test? Phase II Does it work at all? What is the dosage range? Phase III Is it better than placebo? Is it better than other treatments? What are the side-effects

Premarket approval pathway:

Premarket approval pathway Biologics IND – Investigational new drug application Drugs NDA – New drug application Devices IDE-Investigational device exemption Combination products

Drugs and Biologics Marketing regulations:

Drugs and Biologics Marketing regulations 21 CFR parts 210,211,225,&226 good manufacturing practices for drugs and biologics 21 CFR parts 600,601,&610 biologicals products regulations *21 CFR parts 201,202,203,314 prescription drug regulation *21 CFR parts 25 Environmental impact considerations

What does FDA inspect? :

What does FDA inspect? FDA inspects manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations. Those inspected include vaccine and drug manufacturers blood banks food processing facilities dairy farms animal feed processors FDA also inspects facilities that conduct studies in people (clinical trials) laboratories that conduct studies in animals or microorganisms when these studies are used to apply for FDA approval of a medical product foreign manufacturing and processing sites for FDA-regulated products that are sold in the United States imported products at the border

16 Classification Regulations 21 CFR (part 800-1299):

16 Classification Regulations 21 CFR (part 800-1299) Clinical chemistry and clinical toxicology Hematology and pathology Immunology and microbiology Anesthesiology Cardiovascular Dental Ear, nose and throat Gastroenterology & urology devices General and plastic surgery General hospital and personal use Neurological Ophthalmic Orthopedic and physical medicine Obstetrical and gynecological Radiology 15 Medical Device Definition in Sec 201(h) of the FD&C Act

Two Most Common Pathways to Market in the U.S.:

Two Most Common Pathways to Market in the U.S. Premarket Notification (PMN or 510(K)) Safe and effective to a legally marketed (predicate) device through demonstration of substantial equivalence Class I, II, or III (pre-amendment) Premarket Approval (PMA) Demonstration of safety and effectiveness (supported by clinical data) Class III (new, high risk devices and no predicate device, new indications) 16

Drug application types :

17 Drug Application Types Drug application types A New Drug Application (NDA) contains full reports of safety and efficacy studies conducted by or for applicant or as to which it has right of reference An Abbreviated New Drug Application (ANDA) is for a generic duplicate of an approved NDA product:

Legal Import of Medical Devices into the U.S. Market Section 801(a) – (d) of the FD&C Act:

Legal Import of Medical Devices into the U.S. Market Section 801(a) – (d) of the FD&C Act Subject to examination by FDA even if the product is authorized for marketing in another country. Devices must be safe and effective. Must contain informative and truthful labeling in English. Imported products are required to meet the same standards as domestic goods. Establishment Registration Medical Device Listing Compliant Labeling GMP/Quality Systems Appropriate Marketing Applications unless exempt 510(k) PMA Adverse Event Reporting, Records/Complaint Files

What are General Controls?:

What are General Controls? Basic authorities that provide FDA with the means to regulate medical devices. Applies to all medical devices regardless of classification, are subject to premarket and postmarket regulatory controls. Establishment registration and device listing Premarket notification or 510(k), if not exempt Labeling Misbranding Adulteration Quality Systems Records and Reports / Medical Device Reporting (MDR) 19


Summary If a product is labeled, promoted or used in a manner defined in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act, it will be regulated by the FDA as a medical device . USFDA CDRH’s regulatory paradigm is risk-based classification. The levels of regulatory control are based on the classification. Unless exempt, they require a premarket notification clearance or a premarket approval application. In entering the U.S. medical device market, First determine if it meets definition of medical device. Then determine how the may FDA classify the device, if known. Finally, gather your information, collect the necessary data, organize your submission. Products imported into the U.S. meets the same standards and requirements as domestic goods. 20

CDRH manages risk across the “Total Product Life Cycle” applied across Center activities:

CDRH manages risk across the “Total Product Life Cycle” applied across Center activities 21

Number of API Manufacturing Plants Inspected by US FDA: 2001 – 2007:

Number of API Manufacturing Plants Inspected by US FDA: 2001 – 2007 Source: Newport Horizon Premium™

Indian Landscape for API Manufacture:

Indian Landscape for API Manufacture 23 Abundant amount of API manufactured for local market Abundant amount of API Exported; plenty imported

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