Medical Device Compliance and Post-marketing Activities (Ch. 6) Flashcards
What is 21 CFR Part 807?
21 CFR Part 807
ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
How often do establishment registrations and device listings need to be updated?
Annually
TRUE/FALSE: Initial, annual, and updated registration and listing information may be submitted electronically or via mailed form.
FALSE! Under FDAAA (2007), the FDA requires all initial, annual, and updated registration and listing information to be submitted electronically (unless a waiver has been granted).
An annual establishment registrations user fee must be paid annually through what website?
The Device Facility User Fee (DFUF) website
What types of establishments must register according to 21 CFR 807?
Establishments involved in the manufacture, preparation, propagation, compounding, assembly or processing of medical devices intended for human use
What databases are used to submit registration and listing information?
FDA’s Unified Registration and Listing System (FURLS) and Device Registration and Listing Module (DRLM)
What does FURLS stand for?
FDA’s Unified Registration and Listing System (FURLS)
What does DRLM stand for?
Device Registration and Listing Module (DRLM)
When must the initial establishment registration/device listing information be submitted to the FDA?
- After the facility begins an activity, OR
2. When a device is commercialized
When must the initial establishment registration/device listing information be submitted to the FDA after the facility begins an activity or after a device is commercialized?
30 days
What is 21 CFR 820?
21 CFR 820 = QSR = Quality System Regulations = cGMPs = Current Good Manufacturing Practices
What are the main post-marketing regulations?
- Post-approval studies (PAS)
- Post-market cybersecurity
- Medical device reporting (MDR)
- Post-market surveillance (including complaint handling)
- Recalls, corrections, and removals
- Medical device tracking
- Continuous product improvement
What does PAS stand for?
PAS: Postapproval studies
When may the FDA require a PAS?
Will communicate requirement at the time of a PMA, HDE, or PDP application, a condition of device approval
What is the purpose of a PAS?
To monitor the approved device’s continued safety and effectiveness
(for an HDE: the device’s continued probable benefit)
What is 21 CFR 803?
21 CFR 803
MEDICAL DEVICE REPORTING
What is Medical Device Reporting (MDR)?
MDR: A mechanism to identify and monitor adverse events and certain types of device malfunctions, with the goal of identifying and correcting medical device problems in a timely manner
What is the definition of a device user facility?
Device User Facility:
A hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility (not a doctor’s office)
What is the definition of an importer?
Importer:
Any person who imports a device into the US, and who furthers the marketing of a device from the original place of manufacture to the person who makes final delivery/sale
(does not repackage or otherwise change the container/labeling/packaging)
What is the definition of a manufacturer?
Manufacturer:
Any person who manufactures, prepares, propagates, compounds, assembles, or processes a device
TRUE/FALSE: A person who repackages or otherwise changes a device’s container, wrapper, or labeling is a manufacturer.
TRUE
What is the definition of “becomes aware”?
Becomes aware:
When any employee becomes aware of a reportable event
What is the definition of “caused or contributed”?
Caused or contributed:
A death or serious injury was or may have been attributed to a medical device, or a medical device was or may have been a factor in a death or serious injury, including events occurring as a result of:
- failure, malfunction, improper or inadequate design, manufacture, labeling, or user error
What is the definition of serious injury?
Serious injury:
An injury or illness that is life-threatening, results in permanent impairment of a body function or permanent damage to a body structure, or necessitates medical or surgical intervention to prevent permanent impairment
What is the definition of permanent?
Permanent: irreversible impairment or damage to a body structure or function
What are the requirements for 21 CFR 803 Subpart C, D, and E for?
21 CFR 803 Subpart C: Device User Facilities
21 CFR 803 Subpart D: Importers
21 CFR 803 Subpart E: Manufacturers
What are the 3 scenarios that device user facilities must report?
DEVICE USER FACILITY
- Death - within 10 days to FDA
- Serious injury - within 10 days to manufacturer
- Annual summary reports - to FDA
What are the requirements for importer reporting?
IMPORTER
Reports of death or serious injury within 30 days to FDA and manufacturer
What are the requirements for manufacturer reporting?
MANUFACTURER
- Submit reports within 30 days to FDA if device may have caused or contributed to a death or serious injury
- Devices has malfunctioned, and it would be likely to cause or contribute to a death or serious injury if the malfunction were to recur
What does eMDR and ESG stand for?
eMDR: electronic Medical Device Reporting
ESG: Electronic Submissions Gateway
What is the MAUDE database?
MAUDE: Manufacturer and User Facility Device Experience Database
What are the criteria for the FDA requiring a postmarket surveillance study?
- Its failure would be reasonably likely to have serious adverse health consequences.
- It is expected to have significant use in pediatric populations.
- It is intended to be implanted in the body for more than one year.
- It is intended to be a life-sustaining or life-supporting device used outside a device user facility.
What class of devices does a 522 postmarket surveillance study apply to?
Class 2 & Class 3
What is the definition of a recall?
Recall:
A firm’s removal or correction of a marketed product that FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action
What is the definition of correction?
Correction:
Repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location
What is the definition of removal?
Removal:
The physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection
What is the purpose of a device recall, correction, or removal?
To reduce the risks the device poses, or to correct device violations
What is the definition of a market withdrawal?
Market withdrawal:
A correction or removal or a distributed device that involves a minor violation of the act that would not be subject to legal action by the FDA, or that involves no violation of the act (i.e. normal stock rotation practices)
What is the definition of routine servicing
Routine servicing:
Any regularly scheduled maintenance of a device, including replacing parts at the end of their normal life expectancy (e.g. calibration, battery replacements, and responses to normal wear/tear)
What is the definition of stock recovery?
Stock recovery:
A firm’s removal or correction of a product that has not been marketed or that has not left the firm’s direct control
TRUE/FALSE: Market withdrawals, routine servicing, and stock recovery are not considered to be recalls.
TRUE!
What are the regulations for voluntary and mandatory recalls?
21 CFR 7: Enforcement Policy
21 CFR 810: MEDICAL DEVICE RECALL AUTHORITY
21 CFR 806: MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
What is a Health Hazard Evaluation (HHE)?
Health Hazard Evaluation (HHE)
A tool for classifying a voluntary recall by a firm, that considers the following:
- diseases or injuries that have already occurred from the product’s use
- assessment of the hazard
- assessment of the hazard’s degree of seriousness
- assessment of the hazard’s likelihood of occurrence
What is a Health Risk Assessment (HRA)?
Health Risk Assessment (HRA)
A tool for predicting possible harm that can come from a defective or malfunctioning device
What are the 3 classes of recalls?
Class I - use of or exposure to the device will cause serious adverse health consequences or death (most serious class)
Class II - use of or exposure to the device may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote
Class III - use of or exposure to the device is not likely to cause adverse health consequences
What is 21 CFR 821?
21 CFR 821
MEDICAL DEVICE TRACKING REQUIREMENTS
What is the purpose of medical device tracking?
- To ensure that tracked devices can be traced from the manufacturing facility to the patient
- To ensure that manufacturers can expeditiously remove potentially dangerous or defective devices from the market and/or notify patients of significant device problems
* *traceability**
How does the manufacturer know if their device must be tracked?
FDA will issue tracking orders to the manufacturer to confirm the tracking requirements for that device
What types of devices are subject to device tracking requirements?
Class II or III medical devices:
- where failure would reasonably result in serious, adverse health consequences, OR
- are intended to be implanted in the human body for more than one year, OR
- or are life-sustaining or life-supporting and are used outside of a device user facility
What are the requirements for exporting a device approved or cleared by the FDA?
- Registered facility
- Device listed with FDA
- Device cleared/approved (or exempt from)
- Meet labeling requirements
- QRS
What are the requirements for exporting a device NOT approved or cleared by the FDA?
- Meet foreign purchaser’s specifications
- In compliance with laws of intended country to export
- Labeled for export
- Not sold in US
What does CECATS stand for?
CECATS:
CDRH Export Certification and Tracking System
