Good morning all.
I am a little bit confused on what to do about submitting or not a 510(k) of a medical device (with its product code).
It is already installed and used in an italian establishment. The intent is to install it and use it only in the US establishment and not to sell it.
Its product code states that a 510(k) is required.
Reading the 21 CFR about 510(k):
Sec. 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use which meets any of the following criteria:
(1) The device is being introduced into commercial distribution for the first time; that is, the device is not of the same type as, or is not substantially equivalent to, (i) a device in commercial distribution before May 28, 1976, or (ii) a device introduced for commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II.
But, from the definitions of commercial distribution in the 21 CFR 807.3 it is stated:
(b) Commercial distribution means any distribution of a device intended for human use which is held or offered for sale but does not include the following:
(1) Internal or interplant transfer of a device between establishments within the same parent, subsidiary, and/or affiliate company;
So, since what above, should we need to submit a 510(k) even if we are not going to sell the device into US market, but only use it in our US establishment?
I hope to read you soon.
Greeting to all.
I am a little bit confused on what to do about submitting or not a 510(k) of a medical device (with its product code).
It is already installed and used in an italian establishment. The intent is to install it and use it only in the US establishment and not to sell it.
Its product code states that a 510(k) is required.
Reading the 21 CFR about 510(k):
Sec. 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use which meets any of the following criteria:
(1) The device is being introduced into commercial distribution for the first time; that is, the device is not of the same type as, or is not substantially equivalent to, (i) a device in commercial distribution before May 28, 1976, or (ii) a device introduced for commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II.
But, from the definitions of commercial distribution in the 21 CFR 807.3 it is stated:
(b) Commercial distribution means any distribution of a device intended for human use which is held or offered for sale but does not include the following:
(1) Internal or interplant transfer of a device between establishments within the same parent, subsidiary, and/or affiliate company;
So, since what above, should we need to submit a 510(k) even if we are not going to sell the device into US market, but only use it in our US establishment?
I hope to read you soon.
Greeting to all.