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 designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).
PB980 ventilator
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)
INVIMA is the regulatory agency for this country?
Colombia
These devices are intended to be used by trained and licensed individuals to gain a view of the vocal cords during medical procedures, typically laryngoscopy.
The McGRATH™ MAC video laryngoscope and McGRATH™ disposable laryngoscope blades
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.
These devices are intended for the following uses
-use to assist verification of tube placement during endotracheal or nasotracheal intubation
- Use on intubated patients to detect approximate ranges of end-tidal CO2 when clinically significant
EASYCAP and/or PEDICAP
(one answer is ok)
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 device is intended for use in providing tracheal access for airway management.
Tracheostomy tube/Endotracheal tube/ Tracheal tube
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
Name two types of filters used for conditioning gases which are intended to be inhaled by the patient.
Electrostatic, HME, Mechanical Filter
(Will accept antibacterial filter)
The series of ISO 10993 standards entail this:
Biocompatibility of medical devices to manage biological risk