Regulatory Open Forum

Hello, I am having trouble trying to locate the correct source documentation which clearly defines the correct answer for this question. Any feedback or insight as to how you would answer this question and what supporting reference documentation you would utilize. Any insights are appreciated! (I am also going to submit this question to FDA DICE to see what their thoughts are.)

A company intends to add an indication for use to a 510(k) device that is currently being marketed, but has not yet been distributed. Which type of submission is most appropriate?
A) A PMA
B) An Investigational Device Exemption
C) A Special 510(k)
D) A traditional or abbreviated 510(k)

Hi. I have chosen "(C) A Special 510(k) " because expanded indications may result in the need for additional verification and validation testing. Therefore, this change cannot be reviewed in a summary or risk analysis format in a Special 510(k). (C) is the most appropriate among (A)~(D).<o:p></o:p>

Please refer to the FDA guidance "The Special 510(k) Program": https://www.fda.gov/media/116418/download<o:p></o:p>

Hello, I am having trouble trying to locate the correct source documentation which clearly defines the correct answer for this question. Any feedback or insight as to how you would answer this question and what supporting reference documentation you would utilize. Any insights are appreciated! (I am also going to submit this question to FDA DICE to see what their thoughts are.)

A company intends to add an indication for use to a 510(k) device that is currently being marketed, but has not yet been distributed. Which type of submission is most appropriate?
A) A PMA
B) An Investigational Device Exemption
C) A Special 510(k)
D) A traditional or abbreviated 510(k)

Hello, I am having trouble trying to locate the correct source documentation which clearly defines the correct answer for this question. Any feedback or insight as to how you would answer this question and what supporting reference documentation you would utilize. Any insights are appreciated! (I am also going to submit this question to FDA DICE to see what their thoughts are.)

A company intends to add an indication for use to a 510(k) device that is currently being marketed, but has not yet been distributed. Which type of submission is most appropriate?
A) A PMA
B) An Investigational Device Exemption
C) A Special 510(k)
D) A traditional or abbreviated 510(k)

Michaela, the most direct reference would be the FDA Guidance When to Submit a 510(k) for a Change to an Existing Device (issued Oct 2017); see example A1.

Hello, I am having trouble trying to locate the correct source documentation which clearly defines the correct answer for this question. Any feedback or insight as to how you would answer this question and what supporting reference documentation you would utilize. Any insights are appreciated! (I am also going to submit this question to FDA DICE to see what their thoughts are.)

A company intends to add an indication for use to a 510(k) device that is currently being marketed, but has not yet been distributed. Which type of submission is most appropriate?
A) A PMA
B) An Investigational Device Exemption
C) A Special 510(k)
D) A traditional or abbreviated 510(k)

Hello, I am having trouble trying to locate the correct source documentation which clearly defines the correct answer for this question. Any feedback or insight as to how you would answer this question and what supporting reference documentation you would utilize. Any insights are appreciated! (I am also going to submit this question to FDA DICE to see what their thoughts are.)

A company intends to add an indication for use to a 510(k) device that is currently being marketed, but has not yet been distributed. Which type of submission is most appropriate?
A) A PMA
B) An Investigational Device Exemption
C) A Special 510(k)
D) A traditional or abbreviated 510(k)

Hello, I am having trouble trying to locate the correct source documentation which clearly defines the correct answer for this question. Any feedback or insight as to how you would answer this question and what supporting reference documentation you would utilize. Any insights are appreciated! (I am also going to submit this question to FDA DICE to see what their thoughts are.)

A company intends to add an indication for use to a 510(k) device that is currently being marketed, but has not yet been distributed. Which type of submission is most appropriate?
A) A PMA
B) An Investigational Device Exemption
C) A Special 510(k)
D) A traditional or abbreviated 510(k)