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Laminating abbreviated Operators Manual to IFU's and DFU's

M

MDDRegAffairs

#1
Dear all,

After receiving user feedback on a currently 510(k) cleared device we are investigating the option of affixing a laminated abbreviated operators manual to the device. Currently, neither the operators manual or directions for use are laminated. The device is used while the patient is admitted and lying in a bed and can be moved from room to room for use with multiple patients. My uncertainties are:

1. What if any regulatory requirements are associated with lamenting the operators manual and directions for use (i.e., abbreviated 510(k))?

2.1 Are any new risks introduced by attaching an abbreviated operators manual to the device?

2.2 If yes, how can these risks be mitigated (i.e., disclaimers)?

Any comments would be greatly appreciated,

Regards,

Tom
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
Dear all,

After receiving user feedback on a currently 510(k) cleared device we are investigating the option of affixing a laminated abbreviated operators manual to the device. Currently, neither the operators manual or directions for use are laminated. The device is used while the patient is admitted and lying in a bed and can be moved from room to room for use with multiple patients. My uncertainties are:

1. What if any regulatory requirements are associated with lamenting the operators manual and directions for use (i.e., abbreviated 510(k))?

2.1 Are any new risks introduced by attaching an abbreviated operators manual to the device?

2.2 If yes, how can these risks be mitigated (i.e., disclaimers)?

Any comments would be greatly appreciated,

Regards,

Tom
1. It's your responsibility to investigate and identify any such requirements, and comply.

2.1 Yes.

2.2 Run a documented risk management session, decide and implement as required.

Cheers,
Ronen.
 
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