Overview of US Regulatory Pathways (Ch. 2) Flashcards
What is the CFR?
CFR: Code of Federal Regulations, the official compilation of all regulations
What is the USC?
USC: US Code, the official compilation of codified laws by subject
How often is the CFR updated?
Annually (typically in April for Title 21)
What is the Federal Register?
A daily publication of a summary of all changes, updates, and revisions to regulations
What does ICH stand for?
ICH: International Council for Harmonization
What are two groups that publish regulatory guidelines?
- FDA
2. ICH
What does the FDA use to encourage compliance with laws and regulations?
- Scientific review
- Inspections of manufacturing controls
- Advertising controls
- Laboratory product testing
- Postmarket activities
What law constitutes basic US food and drug law?
The FD&C Act and its amendments (Food, Drug, and Cosmetic Act)
Who publishes the e-CFR?
GPO: US Government Publishing Office
What does GPO stand for?
GPO: US Government Publishing Office
What is the e-CFR?
e-CFR: electronic version of the CFR
What does the FDA regulate?
- human drugs
- biologics
- medical devices
- animal drugs
- tobacco products
- food (including animal food)
- cosmetics
- electronic products that emit radiation
What is the HHS?
HHS: Department of Health and Human Services
What is the PHS?
PHS: Department of Public Health Services
What organizations is the FDA under?
HHS and PHS
What does CDER stand for?
CDER: Center for Drug Evaluation and Research
What does CBER stand for?
CBER: Center for Biologic Evaluation and Research
What does CFSAN stand for?
CFSAN: Center for Food Safety and Applied Nutrition
What does CDRH stand for?
CDRH: Center for Devices and Radiological Health
What are CPGMs?
CPGM’s: Compliance Program Guidance Manuals, the FDA’s SOPs that instruct FDA employees on how to conduct activities in compliance
What are MAPPs?
MAPP: Manual of Policies and Procedures, CDER’s manual to document its internal policies and procedures
What are SOPPs?
SOPP: Standard Operating Procedures and Policies, CBER’s SOP system
What law created a formal process for meetings with the FDA, including the SPA process?
PDUFA II, Prescription Drug User Fee Act of 1997 (reauthorization of 1992 act)
What does SPA stand for?
SPA: Special protocol assessment
What is the SPA process?
SPA: Special protocol assessment,
FDA evaluates certain protocols within 45 days to determine whether the SPA meets the scientific/regulatory requirements that the sponsor identified
What is the FDA definition of a medical device?
Medical Device:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory that:
- Is recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and,
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
(The term “device” does not include software functions excluded pursuant to section 520(o).)
What law is considered to have started the modern age of medical device regulations?
Medical Device Amendments of 1976
What did the 1976 Medical Device Amendments include?
1976 Medical Device Amendments:
- Redefined medical devices (from drugs)
- Established device safety and performance/effectiveness standards
- Established FDA premarket review
- Established the medical device classification system
- Created two routes to market
- Established IDE’s
What does SMDA stand for?
SMDA: Safe Medical Devices Act of 1990
What did the Safe Medical Devices Act of 1990 do?
Safe Medical Devices Act (SMDA) of 1990:
- Expanded adverse event reporting for user facilities
- required high-risk device tracking
- Required 510(k) to receive FDA clearance prior to marketing
- FDA allowed to regulate combination products
- Defined HDE
- Gave FDA recall authority
What are the required controls for Class I devices?
General Controls
Which class of medical devices is the highest risk?
Class III
What are the required controls for Class II devices?
General Controls + Special Controls
What are the required controls for Class III devices?
General Controls + Special Controls + Premarket Authorization (PMA)
What are general controls?
- Establishment registration
- Device listing
- Good Manufacturing Practices
- Device labeling
- Submitting a premarket notification 510(k), unless exempt
What are special controls?
Special labeling requirements, mandatory performance standards, and postmarket surveillance activities
What is a premarket approval application (PMA)?
PMA: The required scientific review process to ensure Class III device safety and effectiveness before placing a device on the market
Which branch of the FDA reviews medical devices associated with blood collection/processing or biological technology?
CBER
What are some questions to ask to determine a device definition/classification?
- What will the device do (intended use)?
- What clinical conditions or patient populations will the device be used for (indications for use)?
- How does the device work (principles of operation)?
- What are the product features (product characteristics)?
- What are the device’s inherent benefits and risks?
What does HUD stand for?
HUD: Humanitarian Use Device
What does HDE stand for?
HDE: Humanitarian Device Exemption
What is a humanitarian use device (HUD)?
HUD: A medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year
What is a humanitarian device exemption (HDE)?
HDE: a marketing application/submission for an HUD
What does IRB stand for?
IRB: Institutional Review Board
True/False: An HUD may only be used in facilities with an established IRB?
True!
