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US Medical Device Regulations > US History (Ch. 1) > Flashcards

US History (Ch. 1) Flashcards

1
Q

What are the three branches of the US Government?

A
  1. The Legislative Branch
  2. The Executive Branch
  3. The Judicial Branch
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2
Q

What branch of the US government is responsible for making laws?

A

Legislative

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3
Q

What branch of the US government is responsible for executing laws?

A

Executive

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4
Q

What branch of the US government is responsible for evaluating laws?

A

Judicial

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5
Q

What does FDA stand for?

A

The US Food and Drug Administration

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6
Q

How do the three branches of US government affect the FDA?

A

They guide the regulations for products that are under the FDA’s jurisdiction

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7
Q

What are the two parts of Congress?

A
  1. The House of Representatives

2. The Senate

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8
Q

How does Congress affect the FDA?

A

Congress uses its authority to 1) regulate interstate commerce, and 2) legislate federal statutes on food/drugs

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9
Q

What is the process for a bill to become a statute?

A

Bill / Joint Resolution > Subject matter committees / public hearings > House/Senate votes > Signed by President > Statute

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10
Q

What is a statute?

A

An enacted law

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11
Q

What is a public law?

A

A law that affects society as a whole (e.g. food, drugs)

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12
Q

What is a private law?

A

A law that affects an individual or a small group

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13
Q

What is a slip law?

A

The first official publication of a statute (published separately)

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14
Q

What is the NARA, and what do they do?

A

National Archives and Records Administration (NARA),(Office of the Federal Register), prepares slip laws and adds marginal notes with explanatory info

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15
Q

What is the US Statutes at Large?

A

A permanent collection of all laws enacted during each session of Congress (prepared by the Office of the Federal Register)

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16
Q

What is the United States Code (U.S.C.)?

A

Statutes are published, or “codified” in the U.S.C. (e.g. Title 21 is federal statutes on food and drugs), prepared by the Law Revision Council of the House of Representatives

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17
Q

What is the HHS?

A

Department of Health and Human Services (HHS)

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18
Q

What branch of the government is the FDA under?

A

Executive branch, HHS

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19
Q

What is the purpose of the FDA?

A

To implement statutes through regulations, the mission is to protect public health by ensuring the safety of 1) food, 2) drugs, and 3) cosmetics

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20
Q

What are regulations?

A

interpret laws and describe how they will be enforced

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21
Q

What is rulemaking?

A

A process the FDA uses to propose and establish regulations

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22
Q

What is the Administrative Procedure Act (APA) of 1946?

A

Administrative Procedure Act (APA) of 1946:
Requires agencies to keep the public informed, and gives the public the right to participate in the rulemaking process by commenting on proposed regulations

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23
Q

What is the Government in the Sunshine Act of 1976?

A

Government in the Sunshine Act of 1976:
Requires advanced notice of rulemaking meetings, and that those meetings are open to the public (Unified Agenda provides regulatory agenda with planned rulemaking activities for 6 months)

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24
Q

What is the Federal Register (FR)?

A

Where new regulations, or changes to existing regulations are published (similar to US Statutes at Large)

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25
Q

What is the Code of Federal Regulations (CFR)?

A

Where regulations are published (similar to U.S. Code), organized into 50 titles

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26
Q

What is the CFR formatting?

A

Title #, “CFR”, Part #, “.”, Section # (e.g. 21 CFR 10.3)

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27
Q

What are FDA guidance documents?

A

Used to convey the FDA’s “current thinking” or enforcement priorities to establish regulatory principles and practices aligned with that thinking (not legally binding)

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28
Q

What is a treaty?

A

A written agreement between sovereign states (or other international bodies) dictating terms binding the parties to the agreement, becoming international law once signed

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29
Q

What is a trade agreement?

A

Establishes terms between parties regarding tariffs/trade restrictions

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30
Q

What is case law?

A

Law based on judicial opinions (as opposed to legislative law), judicial decisions set precedents that influence food and drug laws/regulations

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31
Q

What is the United States Reports?

A

The official record of the proceedings of the Supreme Court

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32
Q

How have judicial opinions influenced food/drug regulations?

A

Regulating false claims, chemicals in the food supply, labeling, ability to prosecute responsible individuals of a corporation, drug efficacy, scope of drug/devices

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33
Q

Who is Harvey Wiley?

A

(1902) Had concerns about the safety of food preservation chemicals (Poison Squad experiments)

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34
Q

What was Upton Sinclair’s book?

A

“The Jungle”, described the unsanitary conditions in the meat packing industry

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35
Q

What is the Pure Food and Drug Act of 1906?

A

Pure Food and Drug Act of 1906:
Prohibited misbranded and unadulterated foods, drinks, and drugs from entering interstate commerce (the predecessor of the FD&C Act)

36
Q

What is the Sherley Amendment of 1912?

A

Sherley Amendment of 1912:

Prohibited labeling medicines with false therapeutic claims (however, burden to prove intent placed on govt.)

37
Q

What is the Food, Drug, and Cosmetic Act (FD&C Act) of 1938?

A

Food, Drug, and Cosmetic Act (FD&C Act) of 1938:
- Manufacturers are required to provide scientific proof that new drugs were safe for their intended use prior to being placed on the market
- Cosmetics and medical devices now regulated
- Prohibit adding poisonous substances to food
- FDA allowed to prosecute
(repealed the Pure Food and Drug Act and the Sherley Amendment)

38
Q

What was Elixir Sulfanilamide?

A

A significant public health event:
An antibacterial drug was dissolved in diethylene glycol for oral administration, no safety testing performed, and caused over 100 deaths

39
Q

What is the Public Health Service Act (PHS Act) of 1944?

A

Public Health Service Act (PHS Act) of 1944:

  • Gave the FDA authority over biological products (vaccines, serums)
  • Requires application process for licensing new biological products
40
Q

What is the Durham-Humphrey Amendment of 1951?

A

Durham-Humphrey Amendment of 1951:

  • Defined prescription drug vs. over-the-counter drug
  • Habit-forming or potentially harmful drugs must be prescription only
  • Prescription drugs must have an RX statement
41
Q

What is the Food Additives Amendment of 1958?

A

Food Additives Amendment of 1958:

- Identified substances added to food that are GRAS substances, and non-GRAS that require marketing approval

42
Q

What are GRAS substances?

A

GRAS: Generally Recognized As Safe

43
Q

What is the Kefauver-Harris Amendment, aka Drug Amendments of 1962?

A

Kefauver-Harris Amendment, aka Drug Amendments of 1962:

- Addresses standards for both SAFETY and EFFICACY that must be met before a drug is marketed in the US

44
Q

Who was Frances Kelsey?

A

A significant public health event:
In the 1960’s, Frances Kelsey was an FDA employee who reviewed the application for thalidomide, a morning sickness medicine marketed in 46 other countries. Not approved on basis of drug SAFETY, actually caused severe birth defects worldwide

45
Q

Who was Senator Estes Kefauver?

A

In the 1950’s, Senator Estes Kefauver called for reform on drug price-gouging, false advertising, and called for proof of EFFICACY

46
Q

What law introduced the concepts of SAFETY and EFFICACY?

A

The Kefauver-Harris Amendment, aka Drug Amendments of 1962

47
Q

What are the 1976 Medical Device Amendments (to the FD&C Act)?

A

1976 Medical Device Amendments:

  • Established three medical device classes with different levels of regulatory scrutiny
  • Device listing
  • Establishment registration
  • Adherence to Good Manufacturing Practices
48
Q

What law introduced the requirements for device listing and establishment registration?

A

1976 Medical Device Amendments

49
Q

What law caused medical devices to be regulated?

A

Food, Drug, and Cosmetic Act (FD&C Act) of 1938

50
Q

What is the Cooper Commission?

A

In 1970, the Cooper Commission published the Cooper Report, which found that many deaths/serious injuries were caused by medical devices. (Led to the 1976 Medical Device Amendments)

51
Q

What is the Orphan Drug Act of 1983?

A

Orphan Drug Act of 1983:
- Provides incentives for manufacturers to develop “orphan drugs” (originally defined as a drug for a disease or condition which is rare)

52
Q

What is the Safe Medical Devices Act (SMDA) of 1990?

A

Safe Medical Devices Act (SMDA) of 1990:

  • Added reporting requirements for device user facilities
  • Defined a medical device
  • Added requirements for device tracking and post-market surveillance
  • Provides civil penalties for violating the FD&C Act
  • Created incentives for orphan or humanitarian use devices
  • Add preproduction design controls to the Current Good Manufacturing Practice (CGMP) regulation
53
Q

What does SMDA stand for?

A

Safe Medical Devices Act (SMDA) of 1990

54
Q

What are the 1992 Medical Device Amendments?

A

1992 Medical Device Amendments:

  • Clarified terms
  • Established a single reporting standard for device user facilities, manufacturers, importers, and distributors
55
Q

When were design controls introduced to the QSR?

A

In 1996, design controls were added to the Quality Systems Regulation (QSR)

56
Q

What does QSR stand for?

A

Quality Systems Regulation (21 CFR 820)

57
Q

What is the Drug Price Competition and Patent Term Restoration Act of 1984, aka Hatch-Waxman Act?

A

Drug Price Competition and Patent Term Restoration Act of 1984, aka Hatch-Waxman Act:

  • Established a process for approving drugs based on comparison to an already approved product (due to lengthy reviews)
  • Exclusive marketing status for a period of time based on the drug’s approval process time
  • Provided patent term extension (as an incentive for time lost during regulatory approval process)
58
Q

What is the Biologics Price Competition and Innovation (BPCI) Act of 2010?

A

Biologics Price Competition and Innovation Act of 2010:
- Biosimilar products can be approved based on similarity
(amended the PHS Act)

59
Q

What is a biosimilar product?

A

A biological product may be demonstrated to be “biosimilar” if data shows that the product is “highly similar” to an already-approved biological product (ref. Biologics Price Competition and Innovation Act of 2010)

60
Q

What does BPCI stand for?

A

Biologics Price Competition and Innovation Act of 2010

61
Q

What does PDUFA stand for?

A

Prescription Drug User Fee Act

62
Q

What is the Prescription Drug User Fee Act (PDUFA I) of 1992?

A

Prescription Drug User Fee Act of 1992 (PDUFA I):

  • Allowed the FDA to collect user fees for drugs/biological products
  • Required annual fees for each marketing establishment and each drug marketed
63
Q

What is the purpose of user fees?

A

Industry provides the funding (through user fees) in exchange for the FDA’s agreement to meet drug review performance goals/timelines

64
Q

What does MDUFMA stand for?

A

Medical Device User Fee and Modernization Act

65
Q

What is the Medical Device User Fee and Modernization Act (MDUFMA) of 2002?

A

Medical Device User Fee and Modernization Act (MDUFMA) of 2002:
- Required medical device companies to pay fees to the FDA

66
Q

What is the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012?

A

Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012:

  • Collect user fees from the generic drug and biosimilar biologics industry
  • Reauthorized existing user fees
  • Created new programs for timely access to medicine: reporting drug shortages and drug supply chain controls (suppliers become part of the QMS)
  • Created the GAIN program
67
Q

What does FDASIA stand for?

A

Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012

68
Q

What does GAIN stand for?

A

Generating Antibiotic Incentives Now (GAIN)

69
Q

What is the GAIN program?

A

Generating Antibiotic Incentives Now (GAIN):

  • Provides incentives for antibacterial and antifungal drugs that treat serious or life-threatening infections that are designated as QIDPs
    (e. g. fast-track, priority review, 5-year exclusivity extension)
70
Q

What are QIPDs?

A

Qualified Infectious Disease Products (QIDPs)

71
Q

What is the Food & Drug Administration Modernization Act (FDAMA) of 1997?

A

Food & Drug Administration Modernization Act (FDAMA) of 1997:

  • Provided additional authority for drug/biologic postmarket monitoring
  • Expedited review for some medical devices
  • Clarified SMDA’s humanitarian device provisions
  • Allowed the FDA to recognize other national and international standards
  • Encouraged the least burdensome approach of establishing substantial equivalence
  • Repealed SMDA’s tracking requirements for high-risk devices, and instead established process where FDA can mandate device tracking
72
Q

What does FDAMA stand for?

A

Food & Drug Administration Modernization Act (FDAMA) of 1997

73
Q

What does FSMA stand for?

A

Food Safety Modernization Act (FSMA) of 2011

74
Q

What is the Food Safety Modernization Act (FSMA) of 2011?

A

Food Safety Modernization Act (FSMA) of 2011:

  • Was a big food safety reform
  • Gave FDA new enforcement authority
  • Focused on prevention and risk-based food safety standards
  • Provided new tools to respond to food problems
  • FDA can hold imported foods to same food safety standards
75
Q

What does DQSA stand for?

A

Drug Quality and Security Act (DQSA) of 2013

76
Q

What is the Drug Quality and Security Act (DQSA) of 2013?

A

Drug Quality and Security Act (DQSA) of 2013:

  • Title I: pharmacy compounding
  • Title II: supply chain security
77
Q

Drug Quality and Security Act (DQSA) of 2013: Title I, The Compounding Quality Act

A

Drug Quality and Security Act (DQSA) of 2013: Title I, The Compounding Quality Act:
- Created a category for an outsourcing facility

78
Q

Drug Quality and Security Act (DQSA) of 2013: Title II, Drug Supply Chain Security Act

A

Drug Quality and Security Act (DQSA) of 2013: Title II, Drug Supply Chain Security Act:
- Electronic tracking system for certain prescription drugs in the US

79
Q

What is the Controlled Substances Act of 1970?

A

Controlled Substances Act of 1970:

  • FDA could recommend controls is a product has abuse potential
  • The DEA places the product in a schedule I - VI
80
Q

What does DEA stand for?

A

Drug Enforcement Administration

81
Q

What is the Improving Regulatory Transparency for New Medical Therapies Act of 2015?

A

Improving Regulatory Transparency for New Medical Therapies Act of 2015:
- Requires the DEA to schedule a drug within 90 days after FDA recommendation
(amended the Controlled Substances Act)

82
Q

What is the 21st Century Cures Act (CC&A) of 2016?

A

21st Century Cures Act (CC&A) of 2016:
- Patient-focused drug development
- Advancing new drug therapies
- Modern trial design and evidence development
- Patient access to therapies and information
- Antimicrobial innovation and stewardship
- Medical device innovations
- Improving FDA scientific expertise and outreach
- Medical countermeasures innovation
- Vaccine access, certainty, and innovation
(amends the FD&C Act and PHS Act)

83
Q

What is patient experience data?

A

Includes data collected by any persons, including patients, their family members and caregivers, patient advocacy organizations, disease research foundations, researchers, and drug manufacturers; intended to provide information about patients’ experiences with a disease or condition, including a therapy’s impact and patient treatment preference

84
Q

What law allows the use of patient experience data?

A

21st Century Cures Act (CC&A) of 2016 (to improve patient-focused drug and device development by allowing patient experience data)

85
Q

What is the Right to Try Act of 2018?

A

Right to Try Act of 2018:
- Allows patients with life-threatening diseases or conditions, who have tried all approved treatment options and are unable to participate in a clinical trial, to access unapproved treatments

US Medical Device Regulations (11 decks)

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