Will this application require 510k or not ?

K

kingkobra

I have mobile medical application which is the accessory of the device which is classified under class 2 . Now my medical application is controlling that device , then should I classify my application as per this text ..

Accessories to classified devices take on the same classification as the "parent" device. An accessory such as software that accepts input from multiple devices usually takes on the classification of the "parent" device with the highest risk, i.e., class.


or As it is does not have any predicate device , will it consider as class 3 under this definition ...

Class III devices are those under current law which “cannot be classified as a class I device because insufficient information exists to determine that the application of general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device,” and
“cannot be classified as a class II device because insufficient information exists to determine that the special controls ... would provide reasonable assurance of [their] safety and effectiveness,” and are “purported or represented to be for a use in supporting or sustaining human life or for a
use which is of substantial importance in preventing impairment of human health,” or present “a potential unreasonable risk of illness or injury, [are] to be subject ... to premarket approval to provide reasonable assurance of [their] safety and effectiveness.”

In other words, general and/or special controls are not sufficient to assure safe and effective use of a Class III device. Class III includes devices which are life-supporting or life-sustaining, and devices which present a high or potentially unreasonable risk of illness or injury to a patient. New devices that are not classified as Class I or II by another means, are automatically designated as
Class III unless the manufacturer files a request or petition for reclassification


Thanks in advance .
 
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T

Tonyw

I agree with Sagai's suggestions. When I'm not sure about something, calling FDA has been really helpful.
 
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