BME410 - Quiz 2

what does MDUFA stand for?

Medical Device User Fees Amendment

What is MDUFA"?

• Price list of fees med device comp have to pay FDA

• Use: when register/list or submit application to bring device to market

how does CDRH define small business?

net income less than $100 million

Safety Assurance Case

• Living doc

• has all risk management activities

• ‘safety story’

what is a claim for a Safety assurance case?

• claim: all reasonable foreseeable hazards have been identified

• includes risk mitigation and evidence

what does FTA stand for?

fault tree analysis

what is FTA used for?

see undesired state of a system

basic event

failure or error in a system component or element (example: switch stuck in open position)

External event

normally expected to occur (not of itself a fault)

undeveloped event

an event about which insufficient information is available, or which is of no consequence

conditioning event

conditions that restrict or affect logic gates (example: mode of operation in effect)

OR gate

output occurs if any input occurs

AND gate

the output occurs only if all inputs occur (inputs are independent from the source)

exclusive OR gate

output occurs if exactly one input occurs

Priority AND gate

output occurs if the inputs occur in a specific sequence specified by a conditioning event.

inhibit gate

output occurs if the input occurs under an enabling condition specified by a conditioning event

what does FMEA stand for?

Failure Mode Effects Analysis

what is FMEA?

risk assessment

goal is to mitigate/eliminate failure

failure mode (FMEA)

way or mode in which something fails.

effects analysis (FMEA)

studying the consequences of those failures

Why does MDUFA change over time?

• The intention is to give FDA funds to hire adequate staff

• fees increase when there is more demand

Traditional 510(k)

• used for any original 510(k)

• for a change to a previously cleared device under 510(k)

who submits a Special 510(k)?

Device manufacturers

Special 510(k)

• submit for changes to their own existing device if the method(s) to evaluate the change(s) are well-established

• the results can be sufficiently reviewed in a summary or risk analysis

what type of device not appropriate for a special 510(K)?

biological products

3 reasons why design/label change for existing device is approp. for special 510(k)?

1. change submitted by the manufacturer

2. performance data unnecessary/necessary has well established methods for evaluating change

3. all performace data can be reviewed in a summary or risk analysis format.

when is Abbreviated 510(k) use?

• FDA guidance docs

• shows compliance with special controls for device type

• voluntary consensus standard

note

510(k)s are characterized as the easy, short, less complicated pathway to market