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Predicate Device - Question on Biocompatibility and IEC 60601-1 Testing Requirements

M

melissa66

#1
I found a predicate device for my device. The predicate did a lot of testing....like biocompatibility and IEC 60601-1. my question is, if my predicate completed these tests, does that mean that I have to have the same testing done too? Is that a requirement when using a SE?
 
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T

temujin

#2
Re: Predicate Device - Question on testing requirements

hi,

Having found a predicate device does not exempt you from testing your product.

It might simplify things, i.e. you can submit a 510(k) to the FDA instead of a PMA. Requirements to Clinically Validate your product might be less stringent.

All product safety tests have to be done with your product.

regards
t.
 

Ajit Basrur

Staff member
Admin
#3
Re: Predicate Device - Question on testing requirements

I found a predicate device for my device. The predicate did a lot of testing....like biocompatibility and IEC 60601-1. my question is, if my predicate completed these tests, does that mean that I have to have the same testing done too? Is that a requirement when using a SE?
If you with the very definition of What is Substantial Equivalence ? , it states -

A device is substantially equivalent if, in comparison to a predicate it does not raise new questions of safety and effectiveness; and demonstrates that the device is at least as safe and effective as the legally marketed device.

A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.
 

Marcelo

Inactive Registered Visitor
#4
Re: Predicate Device - Question on testing requirements

If you work in a risk management framework (let´s say, using ISO 14971) a prescription from a standard is nothing more than a previously identified risk control measure (see 6.2 of ISO 14971) and the tests are the ones to verify the implementation and effectiveness of the risk control (see 6.3 of ISO 14971). A predicate device uses protective measures that are deemed acceptable, but you still have to verify implementation and effectiveness of YOUR implementation of these risk controls measures.
 
M

melissa66

#5
Re: Predicate Device - Question on testing requirements

Have you ever completed a label testing? One which shows whether average consumers can comprehend your products' labels/instrustions?
 
R

regfocus

#6
Re: Predicate Device - Question on Biocompatibility and IEC 60601-1 Testing Requireme

Good question.

Does anyone has more comments? The answers to this question look like still not very straightforward.
 
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