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  2. 2. ۩ 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) 21 CFR Parts 800-1299. 2
  3. 3.  Clinical chemistry and  General and plastic surgery clinical toxicology  General hospital and Hematology and pathology personal use Immunology and  Neurological microbiology  Ophthalmic Anesthesiology  Orthopedic and physical Cardiovascular Dental medicine Ear, nose and throat  Obstetrical and Gastroenterology & urology gynecological devices  Radiology Medical Device Definition in Sec 201(h) of the FD&C Act 3
  4. 4.  Goal: Implement the National Commission’s recommendations 1981: 21 CFR Part 50 (Informed Consent Regulations) 1981: 21 CFR Part 56 (IRB Regulations) ◦ Subpart A: General provisions ◦ Subpart B: Organization and Personnel ◦ Subpart C: IRB Function and Operations ◦ Subpart D: Records and Reports ◦ Subpart E: Administrative Actions for Noncompliance 2001: 21 CFR Part 50, Subpart D – Additional Safeguards for Children in Clinical Investigations 4
  5. 5. ۩ The Food and Drug Administration (FDA),established in 1930 as a part of the US Department of Health and Human Services (DHHS), regulates products accounting for roughly 25% of the United States gross national product. 5
  6. 6. ۩ Virus-Toxin Law of 1902 (also referred to as the Biologics Control Act)۩ Food and Drug Act of 1906۩ Federal Food, Drug and Cosmetic Act [FD&C Act] of 1938:۩ Durham-Humphrey Amendment of 1951:۩ Kefauver-Harris Amendment of 1962:۩ Medical Device Amendments of 1976:۩ Anti-Tampering Regulations (1982): 6
  7. 7. ۩ The U.S. Food and Drug Administration (FDA) is an agency of the US Department of Health and Human Services (DHHS) that is responsible for the safety regulation of: ◦ most types of foods ◦ dietary supplements ◦ drugs ◦ biological medical products ◦ vaccines ◦ radiation-emitting devices ◦ blood products ◦ veterinary products ◦ medical devices ◦ cosmetics 7
  8. 8. ۩ The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs.۩ These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction. 8
  9. 9. ۩ The FDA has its headquarters at White Oak, Maryland. The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico.۩ In 2008, the FDA started opening offices in foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom. 9
  10. 10. Office of Food and Drug Combination Administration Products Center for Veterinary National Center for Devices Toxicological Research Center for Biologics Center for Food Safety andEvaluation and Research Applied NutritionCenter for Devices and Center for Drug Evaluation Radiological Health and Research 10
  11. 11. 11
  12. 12. Office of In-Vitro Office of Device Diagnostic Evaluation Devices & Safety Office of Center for Devices Office ofSurveillance and Science && Biometrics Radiological Health Technology Office of Health Office of & Industry Compliance Programs 12
  13. 13. U.S Food and drug administration Commissioner Center for Food Safety and Applied Nutrition (CFSAN) Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Veterinary Medicine (CVM) Center for Veterinary Medicine (CVM) 13
  14. 14. ۩ The FDA consists of employees drawn from a wealth of science and public health professions.۩ Biologists, physicians, chemists, biomedical engineers, toxicologists, pharmacologists, veterinarians, and specialists in the public health education and communication.۩ FDA employs approximately 11,516 people who work in locations around the United States. 14
  15. 15. As of Oct. 1, 2009, FDA employs the following numbers of people in its centers/offices:Center for Biologics Evaluation and Research 946(CBER)Center for Drug Evaluation and Research (CDER) 2,889Center for Devices and Radiological Health (CDRH) 1,203Center for Food Safety and Applied Nutrition 877(CFSAN)Center for Tobacco Products (CTP) 194Center for Veterinary Medicine (CVM) 436National Center for Toxicological Research (NCTR) 217Office of the Commissioner (OC) 859Office of Regulatory Affairs (ORA) 3,895Total 11,516 15
  16. 16. ۩ They provide FDA with independent advice from outside experts on issues related to human and veterinary drugs, vaccines and other biological products, medical devices, and food.۩ In general, advisory committees include a chair, several members, plus a consumer, industry, and sometimes a patient representative.۩ Additional experts with special knowledge may be added for individual committee meetings as needed. although the committees provide advice to the agency, FDA makes the final decisions. 16
  17. 17. ۩ People nominated as scientific members must be technically qualified experts in their field, such as, Clinical medicine Engineering Biological and physical sciences Biostatistics Food sciences 17
  18. 18. ۩ They also must have experience interpreting and analyzing detailed scientific data, and understanding its public health significance.۩ For Example……۩ people nominated for the Drug Safety and Risk Management Advisory Committee in the Center for Drug Evaluation and Research should be knowledgeable in risk communication, risk management, drug safety, and medical, behavioral, and biological sciences as they apply to risk management and drug abuse. 18
  19. 19. ۩ Foods, except for most meat and poultry products, which are regulated by the U.S. Department of Agriculture. Food additives Infant formulas Dietary supplements Human drugs Vaccines, blood products, and other biologics Medical devices, from simple items like tongue depressors, to complex technologies such as heart pacemakers. 19
  20. 20.  Electronic products that give off radiation, such as microwave ovens and X-ray equipment. Cosmetics. Feed, drugs, and devices used in pets, farm animals, and other animals. Tobacco products. 20
  21. 21. ۩ FDA does not regulate: advertising (except for prescription drugs, medical devices, and tobacco products). alcoholic beverages some consumer products, such as paint, child- resistant packages, baby toys, and household appliances (except for those that give off radiation) illegal drugs of abuse, such as heroin and marijuana. health insurance. meat and poultry (except for game meats, such as venison, ostrich, and snake). Restaurants and grocery stores. 21
  22. 22. ۩ FDA shares the responsibility for regulating these products with other government agencies: Pesticides (FDA, the U.S. Department of Agriculture, and the Environmental Protection Agency regulate these). Water (FDA regulates the labeling and safety of bottled water, while the Environmental Protection Agency develops national standards for drinking water from municipal water supplies). 22
  23. 23. ۩ The FDA is the U.S. Government agency that oversees most foods and medical products.۩ Its job is to make sure that: Food is safe, healthy, and clean. Medicines and medical devices are reasonably safe and effective. Cosmetic products are safe. Animal foods and drugs are safe. Food and medical products have proper labels. 23
  24. 24. ۩ The programs for safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency.۩ The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections. Inspection observations are documented on Form 483. 24
  25. 25. ۩ The Food and Drug Modernization Act states that the FDA has 4 roles: To promote health by reviewing research and approving new products. To ensure foods and drugs are safe and properly labelled. To work with other nations to “reduce the burden of regulation”. To cooperate with scientific experts and consumers to effectively carry out these obligations. 25
  26. 26. ۩ The FDA regulates an enormous number of companies. As of November 2000, the FDAs Official Establishment Inventory, the FDAs database of establishments regulated by the agency, included 135,885 firms including these:  64,756 food and cosmetic firms  37,839 device and radiological health firms (of which roughly 9,500 are mammography facilities)  17,625 human drug firms  7,702 animal drug and feed firms  4,223 biologic firms  2,320 storage warehouses  1,420 miscellaneous food-related facilities 26
  27. 27.  The FDA inspects facilities to ensure compliance with the Food, Drug and Cosmetic Act (FD&C Act) and can seek criminal or civil penalties against both companies and individuals when its regulations are violated. Intentionally defrauding or misleading the FDA or violating the act may be a felony, but the concept of strict liability means that even those who unintentionally violate the act can be prosecuted for missed manors because intent is not required to violate the law. Missed meaner violations may result in fines of up to $1,000 and up to 1 year in prison. 27
  28. 28. ۩ FDA inspects manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations.۩Inspected include: vaccine and drug manufacturers blood banks food processing facilities dairy farms animal feed processors 28
  29. 29. ۩ 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. 29
  30. 30. ۩ FDA conducts several types of inspections to help protect consumers from unsafe products:pre-approval inspection after a company submits an application to FDA to market a new product.routine inspection of a regulated facility.“for-cause” inspection to investigate a specificproblem that has come to FDA’s attention.۩ FDA makes available to the public certain frequently requested records of inspections in an electronic reading room. You would need to file a Freedom of Information request to obtain other records. 30
  31. 31. ۩ A recall is when a product is removed from the market or a correction is made to the product because it is either defective or potentially harmful.۩ Sometimes a company discovers a problem and recalls a product on its own. Other times a company recalls a product after FDA raises concerns. 31
  32. 32. ۩ Review of FDA inspectional guides Investigations Operations Manual (IOM) Compliance Program Guidance Manuals(CPGM) Compliance Policy Guides(CPG) Inspection Technical Guides۩ Review of firm’s Establishment Inspection Report (EIR), Responses to FDA Form 483 etc.۩ Planning of inspections. 32
  33. 33. ۩ FDA Form 482: Notice of inspection.۩ FDA Form 483: Inspectional observations.۩ FDA Form 484: Receipt for physical evidence (e.g., samples) , but not for documentary evidence (e.g., label, copy of records…). 33
  34. 34. •Developing a comprehensive action plan that optimizesthe use of resources to achieve HHS and FDA goals forpublic Health and safety as well as developing andimplementing technology solutions.•Partnering with programs and industry to provide theinnovative information technology that makes it possibleto collaborate across government and globallymaintaining a secure environment in which securityprivacy and confidentiality are addressed perU.S.Government laws regulations . 34
  35. 35. ۩ It is FDA program of on-site inspections to ensure the quality and integrity of the data submitted to the agency from regulated clinical trials of investigational drugs, devices, and biologics.۩ Inspections are made both in the U.S. and internationally at clinical investigator sites, institutional review boards (IRBs), and sponsors.۩ (e.g., pharmaceutical, medical device, and biologic companies, including monitors and contract research organizations or CROs working under the sponsor). 35
  36. 36. ۩ Inspections are conducted by the following FDA Centres under the BIMO program: CDRH – FDA Centre for Devices and Radiologic Health. CDER – FDA’s Centre for Drug Evaluation and Research. CBER – Centre for Biologics Evaluation and Research. CVM – FDA’s Centre for Veterinary Medicine. 36
  37. 37. ۩ Following each BIMO inspection, FDA classifies the overall findings under one of three possible categories:I. NAI ( No Action Indicated)II. VAI (Voluntary Action Indicated)III.OAI (Official Action Indicated) 37
  38. 38. ۩FDA conducted 1024 total BIMO inspections in2007, about the same as the prior year’s 1100inspections. Half of all inspections in 2007 wereclassified NAI.۩ Of this total number of inspections in 2007:636 were of clinical investigators (52% wereNAI, 40% were VAI, 8% were OAI).367 by CDER183 by CDRH77 by CBER9 by CVM 38
  39. 39. ۩221 were of IRBs (51% were NAI, 47% wereVAI, 2% were OAI):101 by CDER92 by CDRH28 by CBER۩88 were of Sponsors (54% were NAI, 24% wereVAI, 22% were OAI):23 by CDER53 by CDRH [usually higher due to larger number of small device companies doing 1st clinical trial]12 by CBER 39
  40. 40. ۩ CDRH’s routine inspections focused on paediatricdevices and drug-eluting stents in 2007 and, in 2008,on implantable orthopaedic products andcardiovascular devices.۩ Between 2000 and 2005, FDA inspected only 1%of all clinical trial sites and 75% of the inspectionswere reviews of already-completed trials for dataverification purposes pursuant to a marketingclearance application. Less than 40% of IRBs wereinspected during that period. 40
  41. 41. ۩ More recently, FDA has intensified its commitment to this area and the number of inspections will undoubtedly rise. Areas of focus: Informed Consent – content, timing, documentation. Protocol Compliance – inclusion/exclusion deviations, patient schedule. IRB reporting – notifications for protocol violations, Serious Adverse Events (SAEs), maintenance of ongoing approval. Disclosure and proper documentation of adverse events at the clinical trial site . Drug/Device accountability . Delegation of investigator responsibility to sub-investigators and other staff . Foreign clinical trial sites. 41
  42. 42. ۩ Each FDA Center has oversight of inspections of research related to the product(s) it regulates۩ Inspections are usually conducted by Office of Regulatory Affairs field investigators Field inspectors are NOT specifically assigned to CDER All Field inspectors are responsible for conducting inspections for all centers (CBER, CDER, CDRH, CFSAN, etc.) 42
  43. 43. 800 723 690700 672 647 667 674600 549 556 Spon500 CI400 IRB/RDRC300 BIOEQ200 GLP100 0 FY01 FY02 FY03 FY04 FY05 FY06 FY07 FY08 43
  44. 44. ۩ Investigational New Drug Forms (IND) FDA 1571 Investigational New Drug Application FDA 1572 Statement of Investigator Instructions for completing FDA forms 1571 and 1572.۩ New Drug Application Forms (NDA) Form FDA-356h Application to Market a New Drug, Biologic, or An Antibiotic Drug For Human Use Form FDA-3397 User Fee Cover Sheet Form FDA-3331 New Drug Application Field Report 44
  45. 45. ۩ Abbreviated New Drug Application Forms (ANDA) for Generic Drug ProductsForm FDA-356h Application to Market a New Drug, Biologic or An Antibiotic Drug For Human Use. Guidance for industry: providing regulatory submissions in electronic format –general consideration. 45
  46. 46. ۩ Orphan Drug Products (for rare diseases and disorders)There is no form, but there is a prescribed format for application for orphan drug status. The section from the regulations that describes the format can be found on this website on the The Orphan Drug Act and Related Law and Regulation page.۩ Electronic Regulatory Submission & Review (ERSR) Regulation and Instructions For Submitting Drug Application Electronic This webpage provides for information on CDERs program to enable the electronic submission of regulatory information to the Center and the review of it by CDER staff. 46.
  47. 47. ۩ FDA Form Distributions Page. includes links to:Certification: Financial Interest and Arrangements of Clinical Investigators.Disclosure: Financial Interest and Arrangements of Clinical Investigators.MedWatch: FDA Medical Product Reporting Program – Voluntary.MedWatch: FDA Medical Products Reporting Program – Mandatory.For electronic form submissions, see Electronic Regulatory Submissions and Review. 47
  48. 48. ۩ There are several ways you can report problems to FDA:Call the FDA Consumer Complaint Coordinator.Report a Serious Medical Product Problem OnlineReport by Mail: Use postage paid Form FDA 3500Report by FaxReport by Phone Report a vaccine-related illness or injury to the Vaccine Adverse Event Reporting System (VAERS). 48
  49. 49. To report complaints about pet food (and other animal feed), all the FDA Consumer Complaints Coordinator. Report complaints online related to FDA- regulated Clinical Trials. Report to FDA’s MedWatch program any product problems or unexpected side effects (adverse events) that occur while using drugs, medical devices, dietary supplements, infant formulas, cosmetics, and blood products and other biologics (except for vaccines) either online, by regular mail, by fax, or by phone. 49
  50. 50. To find the part of FDA that addresses your area ofconcern, see Contact FDA.You may also contact FDA with your comments orquestions•by e-mail•by mail to Food and Drug Administration, 10903New Hampshire Ave., Silver Spring, MD 20993-0002•by telephone at 1-888-INFO-FDA (1-888-463-6332),which is the main FDA phone number for generalinquiries•by contacting the FDA Public Affairs Specialist foryour geographic region 50
  51. 51. 51
  52. 52. Posted by AAHRPP on Monday, January 23,2012۩ In 2011, (FDA) issuedfive warning letters toIRBs. None of the five wasfrom an Association for theAccreditation of HumanResearch ProtectionPrograms (AAHRPP)accredited organization.۩ Since 1996, the FDA hasissued 108 warning lettersto IRBs. 52
  53. 53. 53Posted by attilacsordas on February 28, 2009
  54. 54.
  55. 55.  Insupport of the agencys mission to promote and protect the public health, FDAs Strategic Plan focuses on four strategic goals: 55
  56. 56.  Goal 1: Strengthen FDA for Today and Tomorrow Goal 2: Improve Patient and Consumer Safety Goal 3: Increase Access to New Medical and Food Products Goal 4: Improve the Quality and Safety of Manufactured Products and the Supply Chain 56