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(a) This part implements sections 513, 514(b), 515(b), and 520(l) of the act with respect to the classification and reclassification of devices intended for human use.

(b) This part prescribes the criteria and procedures to be used by classification panels in making their recommendations and by the Commissioner in making the Commissioner's determinations regarding the class of regulatory control (class I, class II, or class III) appropriate for particular devices. Supplementing the general Food and Drug Administration procedures governing advisory committees (part 14 of this chapter), this part also provides procedures for manufacturers, importers, and all other interested parties to participate in proceedings to classify and reclassify devices. This part also describes the kind of data required for determination of the safety and effectiveness of a device, and the circumstances under which information submitted to classification panels or to the Commissioner in connection with classification and reclassification proceedings will be available to the public.[1]

Failure to comply

The remedies provided for in this subchapter shall be in addition to and not in substitution for any other remedies provided by law and shall not relieve any person(s) from liability at common law or under statutory law.[2]

State Laws: Health and Medicine

The following state and local laws also apply to include but not limited to:

  • Alabama Alabama Code > Title 20 - Food, Drugs And Cosmetics
  • Alabama Code > Title 22 - Health, Mental Health And Environmental Control
  • Alaska Alaska Statutes Title 17 - Food And Drugs
  • Alaska Statutes Title 18 - Health, Safety, And Housing
  • Alaska Statutes Chapter 44.29 - Department Of Health And Social Services
  • Arizona Arizona Laws > Title 36
  • Arizona Laws > Title 41 > Chapter 12 - Public Safety
  • California California Health and Safety Code
  • Connecticut Connecticut General Statutes > Title 19a - Public Health and Well-Being
  • Connecticut General Statutes > Title 21a > Chapter 417 - General Provisions. Pure Food and Drugs
  • Connecticut General Statutes > Title 21a > Chapter 418 - Uniform Food, Drug and Cosmetic Act
  • Delaware Delaware Code Title 16 - Health and Safety
  • Delaware Code Title 29 > Chapter 79 - Department Of Health And Social Services
  • Florida Florida Statutes > Title XXIX - Public Health
  • Florida Regulations - Agency for Health Care Administration
  • Florida Regulations > Division 64B - Division of Medical Quality Assurance
  • Florida Regulations > Division 64C - Division of Children's Medical Services
  • Florida Regulations > Division 64E - Division of Environmental Health
  • Florida Regulations > Division 64F - Division of Family Health Services
  • Florida Regulations > Division 64H - Office of Statewide Research
  • Florida Regulations > Division 64I - Division of Health Access and Tobacco
  • Florida Regulations - Department of Health and Rehabilitative Services
  • Hawaii Hawaii Revised Statutes Title 19 - Health
  • Idaho Idaho Code Title 39 - Health And Safety
  • Illinois Illinois Compiled Statutes > Chapter 20 > Dpt Of Healthcare And Family Services
  • Illinois Compiled Statutes > Chapter 20 > Dpt Of Public Health
  • Illinois Compiled Statutes > 45 ILCS 151 - Emergency Management Assistance Compact Act
  • Illinois Compiled Statutes > Chapter 70 > Health
  • Illinois Compiled Statutes > Health And Safety
  • Indiana Indiana Code > Title 7.1 - Alcohol And Tobacco
  • Indiana Code > Title 10 - Public Safety
  • Indiana Code > Title 16 - Health
  • Iowa Iowa Code Title IV - Public Health
  • Kansas Kansas Statutes > Chapter 46 > Article 35 - Joint Committee On Health Policy Oversight
  • Kansas Statutes > Chapter 65 - Public Health
  • Kansas Statutes > Chapter 75 > Article 56 - Department Of Health And Environment
  • Louisiana Louisiana Revised Statutes > Title 36 > Chapter 6 - Department Of Health And Hospitals
  • Louisiana Revised Statutes > Title 40 - Public health and safety
  • Maine Maine Revised Statutes Title 22 - Health And Welfare
  • Maine Revised Statutes Title 22-A - Health And Human Services
  • Maryland Maryland Code > Health - General
  • Maryland Code > Public Safety
  • Massachusetts Massachusetts General Laws > Part I > Title II > Chapter 17 - Department Of Public Health
  • Massachusetts General Laws > Part I > Title II > Chapter 22 - Department Of Public Safety
  • Massachusetts General Laws > Part I > Title XV > Chapter 94 - Inspection And Sale Of Food, Drugs And Various Articles
  • Massachusetts General Laws > Part I > Title XV > Chapter 111 - Public Health
  • Massachusetts General Laws > Part I > Title XV > Chapter 111D - Clinical Laboratories
  • Massachusetts General Laws > Part I > Title XV > Chapter 111K - Catastrophic Illness In Children Relief Fund Commission
  • Massachusetts General Laws > Part I > Title XV > Chapter 111L - Biotechnology
  • Michigan Michigan Laws > Chapter 325 - Health
  • Michigan Laws > Chapter 333 - Health
  • Michigan Laws > Chapter 752 > Act 124 of 1907 - Safety Devices On Corn Huskers
  • Michigan Laws > Chapter 752 > Act 217 of 1933 - Rebuilt Electric Storage Batteries
  • Minnesota Minnesota Statutes - Health
  • Minnesota Statutes - Public Safety
  • Missouri Missouri Laws > Title VII > Chapter 96 - Municipal Health and Welfare
  • Missouri Laws > Title XII
  • Missouri Laws > Title XXI > Chapter 319 - General Safety Requirements
  • Missouri Laws > Title XL > Chapter 650 - Department of Public Safety
  • Montana Montana Code Title 16 - Alcohol And Tobacco
  • Montana Code Title 50 - Health And Safety
  • Montana Code Title 50 - Health And Safety
  • Nebraska Nebraska Statutes > Chapter 71 - Public Health And Welfare
  • Nevada Nevada Revised Statutes > Title 40 - Public Health And Safety
  • New Hampshire New Hampshire Revised Statutes > Title X - Public Health
  • New Hampshire Revised Statutes > Title XII - Public Safety And Welfare
  • New Jersey New Jersey Statutes > Title 24
  • New Jersey Statutes > Title 26
  • New Mexico New Mexico Statutes Chapter 24 - Health and Safety
  • New Mexico Statutes Chapter 26 - Drugs and Cosmetics
  • New York New York Laws - General Business > Article 28-E - Children's Product Safety and Recall Effectiveness Act of 2008
  • New York Laws - General Municipal > Article 6 - Public Health and Safety
  • New York Laws - Public Health
  • New York New York Laws > General Business > Article 28-E - Children's Product Safety And Recall Effectiveness Act Of 2008
  • New York Laws > General Municipal > Article 6 - Public Health And Safety
  • New York Laws > Public Health
  • North Carolina North Carolina General Statutes Chapter 106 > Article 12 - Food, Drugs and Cosmetics
  • North Carolina General Statutes Chapter 106 > Article 12A - Wholesale Prescription Drug Distributors
  • North Carolina General Statutes Chapter 130A - Public Health
  • North Dakota North Dakota Code > Title 23 - Health and Safety
  • Ohio Ohio Code > Title 37
  • Oregon Oregon Statutes > Volume 11 - Public Health; Housing; Environment
  • Rhode Island Rhode Island General Laws > Title 21 - Food And Drugs
  • Rhode Island General Laws > Title 23 - Health And Safety
  • Rhode Island General Laws > Chapter 42-12.1. Department of Mental Health, Retardation, and Hospitals
  • Rhode Island General Laws > Chapter 42-12.4. The Rhode Island Medicaid Reform Act of 2008
  • Rhode Island General Laws > Chapter 42-18. Department of Health
  • South Carolina South Carolina Code > Title 39 > Chapter 23 - Adulterated, Misbranded Or New Drugs And Devices
  • South Carolina Code > Title 39 > Chapter 24 - Drug Product Selection Act
  • South Carolina Code > Title 39 > Chapter 25 - Adulterated Or Misbranded Food And Cosmetics
  • South Carolina Code > Title 44 - Health
  • South Dakota South Dakota Laws > Title 34 - Public Health And Safety
  • South Dakota Laws > Title 39 - Food And Drugs
  • Tennessee Tennessee Code > Title 4 > Chapter 3 > Part 18 - Department of Health
  • Tennessee Code > Title 53 - Food, Drugs And Cosmetics
  • Tennessee Code > Title 68 - Health, Safety and Environmental Protection
  • Texas Texas Health and Safety Code
  • Texas Vernon's Civil Statutes > Title 71 - Health--Public
  • Utah Utah Code > Title 26 - Utah Health Code
  • Utah Code > Future Title 26 - Utah Health Code
  • Vermont Vermont Statutes Title 18 - Health
  • Virginia Virginia Code Title 9.1 > Chapter 3 - Firefighters and Emergency Medical Technicians Procedural Guarantee Act
  • Virginia Code Title 30 > Chapter 18 - Joint Commission on Health Care
  • Virginia Code Title 32.1 - Health
  • West Virginia West Virginia Code > Chapter 16 - Public Health
  • Wisconsin Wisconsin Statutes > Public Health
  • Wisconsin Statutes > Health

[3]

Reference

  1. FDA: Code of Federal Regulations, Title 21, Volume 8. Revised as of April 1, 2013. CITE: 21CFR860.1
  2. ITLE 21--FOOD AND DRUGS: CHAPTER I--FOOD AND DRUG ADMINISTRATION. DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER J--RADIOLOGICAL HEALTH. PART 1003 NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1003
  3. LawServer Online. Health and Medicine Database. Accessdate 24 Dec 2013. http://www.lawserver.com/law/country/us/cfr/21_cfr_892-1750

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