US FDA
If you need to conduct a clinical study in the US for a Class III medical device, what type of application would you submit to the FDA?
Investigational device exemption (IDE)
Name 2 types of economic operators
Manufacturer,
Authorised Rep,
Importer,
Distributor
ANVISA is the regulatory agency for this country
Brazil
This device is a valuable “first alert” because it monitors for hemodynamic changes and deteriorating patient conditions.
INVOS Regional Oximeter
Medical devices Quality management systems Requirements for regulatory purposes
ISO 13485
Name 2 types of enforcement actions
Warning Letters, Seizure, Injunction, Criminal prosecution, Criminal Fines for Food Drug and Cosmetic Act Violations
For a Class I device that is not sterile, not reusable and does not have a measuring function, how is EU conformity established?
Declaration of Conformity (Self-declared)
TGA is the Medical Device regulatory body for this country?
Australia
This device is a remote monitoring application that provides scalability, interoperability, and several integration options.
Vital Sync™ virtual patient monitoring
Medical Devices – Application Of Risk Management To Medical Devices
ISO 14971
The Quality System (QS) Regulation/Medical Device Good Manufacturing Practices can be found in which regulation?
(21 CFR ___)
21 CFR 820
What year was EU Medical Device Regulation released as regulation?
2017
Name the regulatory body in China that regulates medical devices.
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration or CFDA.
What would you use for SpO2 measurements that are tied to true arterial oxygen saturation and cardiac-induced pulse ?
Nellcor™ pulse oximetry
IEC standards apply to devices with these types of components
Electrical, electronic and related technologies
Name 2 FDA Centers
If there is a serious injury, what database should this be reported in?
EUDAMED
What does GMDN stand for?
Global Medical Device Nomenclature
This system provides a direct measurement of the patient’s level of consciousness and insight into the effects of anesthesia on the brain.
Bispectral Index™ (BIS™) Monitoring System
ISO 11135 involves the Sterilization of health-care products using the ethylene oxide sterilization process. Name a different sterilization process.
Gamma radiation, aseptic sterilization
moist heat (steam), dry heat, vaporized hydrogen peroxide, and other sterilization methods (for example, chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide).
If you are submitting a 510(k) to FDA that includes a summary of compliance with special controls, you are submitting what type of 510(k)?
[i.e., Traditional, special, abbreviated, de novo, PMA]
Abbreviated 510(k)
Name 2 Notified Bodies
3EC, BSI Group, DEKRA, Eurofins, Intertek
KIWA, SGS, TUV NORD, TUV Rheinland
TUV SUD
Name 3 participant countries for the Medical Device Single Audit Program (MDSAP)
MDSAP Members
Nonintubated options feature proprietary oral/nasal and nasal-only CO2 sampling, as well as an innovative supplemental oxygen delivery system.
Microstream™ Advance Filter Lines
The series of ISO 10993 standards entail this:
Biocompatibility of medical devices to manage biological risk