Design Control Requirement - Initial Distributor of a Class I Video Laryngoscope

H

hlg1102

#1
Hi Forum,

We are currently an initial distributor of a Class I video laryngoscope device in the US from a UK manufacturing company. 820.30 states specific design control requirements, but only for certain class I devices. Since releasing the device into the market, it has undergone some manufacturing upgrades. Should the design control requirement be considered?
 
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Stijloor

Staff member
Super Moderator
#3
Hi Forum,

We are currently an initial distributor of a Class I video laryngoscope device in the US from a UK manufacturing company. 820.30 states specific design control requirements, but only for certain class I devices. Since releasing the device into the market, it has undergone some manufacturing upgrades. Should the design control requirement be considered?
Another quick bump...
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Hi Forum,

We are currently an initial distributor of a Class I video laryngoscope device in the US from a UK manufacturing company. 820.30 states specific design control requirements, but only for certain class I devices. Since releasing the device into the market, it has undergone some manufacturing upgrades. Should the design control requirement be considered?
Hi,

As long as the device classification hasn't changed (and it now falls under one of the codes NOT exempt from Design Controls) then 820.30 does not apply and design controls would not be mandatory.

Cheers,
Ronen.
 
J

JohnJohnson

#5
Hi,

As long as the device classification hasn't changed (and it now falls under one of the codes NOT exempt from Design Controls) then 820.30 does not apply and design controls would not be mandatory.

Cheers,
Ronen.

I agree with it. :)
 
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