FDA Overview
what is legally required by the FDA for a class I device?
general controls only
what is the FDA's parent agency?
US Department of Health and Human Services (HHS)
list the regulatory agency for European Union
European Medicines Agency (EMA)
list the regulatory agency for the US
FDA
what does the acronym FDA stand for?
Food and Drug Administration
list the regulatory agency for China
State Food and Drug Administration
what are the FDA classification of devices?
class I class II class III
list 6 differences between the FDA and EMA
1.) development of diagnostic tests 2.) monitoring of distribution 3.) patient/physician survey to evaluate understanding of risk 4.) risk evaluation and mitigation strategies (REMS), print advertising 5.) audit of communication plan 6.) audit of pharmacies
what four things does the FDA require of medical device companies
1.) device listing; definition and classification of device 2.) file proper form (510k or PMA) 3.) quality system regulation (QSR) 4.) establishment registration
what does the FDA regulate?
1.) foods, 2.) dietary supplements, 3.) human drugs, 4.) vaccines, 5.) blood products 6.) biologics, 7.) medical devices 8.) cosmetics, 9.) veterinary products, 10.) tobacco products
what are the four core categories of the FDA
1.) medical products and tobacco 2.) foods 3.) global regulatory operations and policy 4.) operations
list 8 similarities between the FDA and EMA
1.) medication guides, 2.) patient information sheet 3.) container labels (contraindications) 4.) provider communication plan 5.) training of healthcare professionals 6.) monitoring of patients; observational studies 7.) prescriber and patient database 8.) post-marketing studies
what are FDA general controls?
1.) register the establishment 2.) list the device with the FDA 3.) comply with labeling 4.) design according to the QSR
give 3 examples of accessory devices?
1.) software 2.) blood tubing kit 3.) major diagnostic x-ray equipment
how many medical device categories exist in the FDA?
16
which form does the FDA require for a Class II medical device?
510 (k) {five-ten-k}
list the regulatory agency for Japan
Pharmaceuticals and Medical Device Agency (PMDA) Japanese Pharmaceutical Affairs Law (JPAL)
list the regulatory agency for Australia/New Zealand
Therapeutic Goods Administration (TGA)
where can FDA regulations be found?
Title 21 in the Code of Federal Regulations (CFR)
list the regulatory agency for middle east countries, Africa, Russia, and third world countries
World Health Organization (WHO)
what is the medical device amendment act?
amendments to Title 21 that expands the definition of devices and provides more detail on device classification
what four characteristics are required by the FDA something to be defined as a device?
an "instrument" that is: 1.) recognized in the US Pharmacopoeia 2.) used in diagnosis, prevention, treatment or mitigation of a disease 3.) non-metabolic 4.) affects structure or function of the body
what is a pre-amendment device?
device designed before 1976 with no modification since then (no PMA required)
what does the acronym GMP stand for?
good manufacturing practices
what burden does every device meet?
it must be SAFE and EFFECTIVE
what are FDA regulations based on?
laws set forth by congress in the Food, Drug and Cosmetic Act (FD & C Act)
what is the QSR?
legislated manufacturing practices for medical devices derived from good manufacturing practices (GMPs) in 1996
what are class 3 devices?
life sustaining medical devices
what is a 510(k)?
marketing application submitted to the FDA for class I and class II medical devices
what is the hierarchy within the FDA?
one commissioner with four directorates
what form does the FDA require for Class III medical devices?
pre-market approval (PMA)
what does the acronym QSR stand for?
quality system regulations
