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1 Plamena Entcheva-Dimitrov, PhD, RAC On-line Course 1

2 The Preferred Regulatory Consulting content in this presentation is copyright protected under United States law and applicable international copyright laws. 2

3 3

4 Federal Agency Part of the Department of Health and Human Services FDA s mission is to protect and promote the public health: noble and honorable job Established in 1938 with an act of Congress under President FD Roosevelt 4

5 Plamena Entcheva-Dimitrov, PhD, RAC 5 5

6 FDA within the Federal Government (* marks major legislations): 1839 Patent Office, Department of State 1849 Chemical Laboratory of the Agricultural Division in the Patent Office, Department of Interior 1862 Chemical Division, Department of Agriculture 1889 Chemical Division, US Department of Agriculture 1890 Division of Chemistry, USDA 1901 Bureau of Chemistry, USDA 1927 Food and Drug Insecticide Administration, USDA 1930 FDA, USDA 1940 FDA, Federal Security Agency 1953 FDA, Department of Health, Education, and Welfare 1979 FDA, Department of Health and Human Services 6

7 Inception of FDA: Per-1906: 1813: the Vaccine Act; first federal law for consumer protection and therapeutic substances All drugs were bought and sold as consumer goods 1848: Drug Importation Act; adulterated quinine in the US Army; lab inspections at ports 1862: Division of Chemistry, FDA s predecessor to inspect food at ports of entry and detention 1902: the Biologics Control Act to license establishments and regulate interstate sale of serum, vaccines and other products used to prevent or treat diseases The father of the FDA: Harvey Washington Wiley Poison Squad of 1903: the influence of food preservatives and colors 7

8 1906: the Pure Food and Drugs Act: signed by President Theodore Roosevelt on June 30, 1906 the law that gave rise to widespread consumer protection in the US prohibits the interstate commerce of misbranded and adulterated foods and drugs 8

9 1912: Sherley s Amendment to prohibit false and fraudulent label claims of therapeutic effectiveness 1927: the Food, Drug and Insecticide Administration, which became FDA in : FD&C (aka The Act) enacted after people died from antifreeze containing drug 1951: Durham-Humphrey Amendment - OTC 1962: Kefauver-Harris Drug Amendments - Thalidomide tragedy 9

10 1970: Poison Prevention Packaging Act child-resistant packaging 1972: Over-The-Counter Review 1976: Medical Device Amendments 1983: Orphan Drug Act 1990: Safe Medical Devices Act Humanitarian Use Devices (HUD), which can be marketed under Humanitarian Device Exemption (HDE) 10

11 1992: Medical Device Amendments device tracking and post-marketing surveillance 2002: MDUFMA user fees are established; established the Office of Combination Products 2012: The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, Gives the authority to collect user fees from industry to fund reviews of innovator drugs (PDUFA V), medical devices (MDUFA III), generic drugs user fee amendments and biosimilar biological products (BsUFA); Promotes innovation to speed patient access to safe and effective products; Increases stakeholder involvement in FDA processes; and Enhances the safety of the drug supply chain. 11

12 12

13 FDA s responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions. Center for Drugs Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) 13

14 CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH) - regulates firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions. 14

15 8 Offices Office of the Center Director Office of Management Operations Office of Compliance (OC) Office of Device Evaluation (ODE) with 7 divisions Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices (DAGRID) Division of Cardiovascular Devices (DCD) Division of Ophthalmic and Ear, Nose and Throat Devices (DOED) Division of Neurological and Physical Medicine Devices (DNPMD) Division of Orthopedic Devices (DOD) Division of Surgical Devices Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD) Office of In Vitro Diagnostic Device Evaluation and Safety with 4 divisions Office of Surveillance and Biometrics with 4 divisions Office of Science and Engineering Laboratories Office of Communication, Education and Radiation Programs 15

16 Medical Devices originally not in the scope of the FD&C Act First regulated in 1976 with the Medical Device Amendments: Medical device safety and effectiveness; 3 classes based on risk to the patient and/or the user; For once it s good to have a grandpa : the pre-amendment devices were grandfathered ; If a device was not on the market as of 28 May 1976, then the device needs to identify a predicate or grandfather to demonstrate substantial equivalence to. Intended Use concept - must be same as predicate Thus far, approximately 1,700 different generic types of devices are grouped into 16 medical specialties referred to as panels 16

17 Does the device raise new or different concerns of safety and/or effectiveness? If yes: the device would require more rigorous regulatory assessment If No: identify a predicate device and claim substantial equivalence Device Classification: Class I: thong depressors, medical gloves, pacemaker charger Class II: endoscopes, vascular catheters, guide wires Class III: heart valves, stents, pacemakers Combination products: drug eluting stents, drug coated leads, bone cement mixed with drug 17

18 Quality Systems Regulations device cgmp requirements (21 CFR part 820) First authorized by section 520(f) of the FD&C Act on July 21, 1978 (43 FR ) Effective on December 18, 1978, and was codified under part 820 Design control concept 18

19 Types of marketing submissions: 510(k) notifications (21 CFR 807) de novo (2012 FDASIA) Pre-Market Approval applications (PMAs; 21 CFR 814) Product Development Protocol (PDP, ) Humanitarian Device Exemption (HDE, 21 CFR 814) for Humanitarian Use Device Types of investigational device submissions: Investigational Device Exemption (IDE) to conduct clinical trials (21 CFR 812) 19

20 The Web: Professional Groups: RAPS DIA AdvaMed LinkedIn 20

21 You have completed a 30-minute regulatory affairs on-line training You can print this page for your records 21

22 Please us at 22

23 23

The draft of this document issued on December 27, 2011.

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