• MORE ARTICLES

• Knowledgebase

• Interpret FDA's QSR

• Find Regulatory Requirements for your country
• GHTF
• Validation Requirements
• Medical Device Software
• Sterilization

• FDA Requirements
• European Union Requirements
• Canadian Requirements

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

...cont'd

2005

Major - We believe the level of concern is Major if a failure or latent flaw could directly result in death or serious injury to the patient or operator. The level of concern is also Major if a failure or latent flaw could indirectly result in death or serious injury of the patient or operator through incorrect or delayed information or through the action of a care provider.

1998

Major - The level of concern is major if operation of the software associated with device function directly affects the patient and/or operator so that failures or latent flaws could result in death or serious injury to the patient and/or operator, or if it indirectly affects the patient and/or operator (e.g., through the action of care provider) such that incorrect or delayed information could result in death or serious injury of the patient and/or operator.

--------------------------------------------------

2005

Moderate

We believe the level of concern is Moderate if a failure or latent design flaw could directly result in minor injury to the patient or operator. The level of concern is also Moderate if a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.

1998

Moderate - The level of concern is moderate if the operation of the software associated with device function directly affects the patient and/or operator so that failures or latent design flaws could result in non-serious injury to the patient and/or operator, or if it indirectly affects the patient and/or operator (e.g., through the action of a care provider) where incorrect or delayed information could result in non-serious injury of the patient and/or operator.

-----------------------------------------------------

2005

Minor

We believe the level of concern is Minor if failures or latent design flaws are unlikely to cause any injury to the patient or operator.

1998

Minor - The level of concern is minor if failures or latent design flaws would not be expected to result in any injury to the patient and/or operator.

.Start of Article                                  ...Next (more)........