Informational Several revised or updates USFDA guidance - 9/9/2019

[Marcelo]

• 9/13/2019 – Format for Traditional and Abbreviated 510(k)s: Guidance for Industry and FDA Staff
• 9/13/2019 – Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff
• 9/13/2019 – The Abbreviated 510(k) Program: Guidance for Industry and Food and Drug Administration Staff
• 9/13/2019 – The Special 510(k) Program: Guidance for Industry and Food and Drug Administration Staff
• 9/9/2019 – Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff
• 9/9/2019 – FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff
• 9/9/2019 – User Fees and Refunds for De Novo Classification Requests : Guidance for Industry and Food and Drug Administration Staff

Posted at Marcelo's Medicaldevice.expert website...

You may comment and discuss in this discussion thread.

 

[Murni Ahmad]

Hi Marchelo,

Thank you for the updates.

Can I check with you, what is OMB form for and why is it having an expiration date despite that the 510K letter to me has no expiry date. am I missing anything?

I am from a distributor company, so I have very minimum information on manufacturing requirements for FDA approval.
I was requested by my auditor a new OMB since the current one has expired despite having the 510K letter listed in FDA.

Where can I read more on this OMB form.

Thank you.

 

[monoj mon]

Your question lacks many vital information.

1. What is the exact name of the form?
OMB means 'Office of Management and Budget (OMB)'. All US government forms include OMB expiration dates and it keeps changing periodically. Refer here and here. Now as you know, OMB form is a common term applied to the officials forms in the US (including FDA's), please ask your auditor which exact form he/she is asking for.

2. Which type of organization your auditor is affiliated to?
Are you talking about any third party auditor for certification purpose or you are talking about FDA Reviewer itself. Those FDA forms with OMB number is usually for the purpose of official use by the FDA, if any third party auditor is asking for it then in my opinion it is a strange request. I am not sure if any other organization uses those FDA forms for auditing purposes.

 

[Murni Ahmad]

Hi Monoj,

Thank you so much for your input.

The auditor is doing evident verification and we are using the 510K letter as a reference for regulatory approval,
There is this form number OMB 0910.0120 expired June 2020, and this form stated the indication for use.
If this has expired, does the indication for use need to be redeclared using a new valid form?

Thank you.

 

[monoj mon]

You reply still lacks information such as (i) why you are being audited based on the 510k letter as a reference for regulatory approval! (ii) where are you seeking regulatory approval! If the auditor is still insisting to use the Latest Version of 'Indication for Use Statement' form then use this link to download it. Remember your browser won't show the content of the PDF, you will need to download it first and then open it to fill it up.

https://www.fda.gov/media/124401/download

 

[monoj mon]

It will be better if you ask the auditor why he/she needs you to reissue the 'Indication for Use Statement' as the original one shall be already cleared by the FDA along with the 510(k) clearance letter.

 

[Murni Ahmad]

Hi there.

(i) why you are being audited based on the 510k letter as a reference for regulatory approval!
- The product is approved by USFDA (by our foreign manufacturer), and we are the local distributor responsible to register the product locally. My country accepts 510K approval as reference for local registration, and our local auditor is doing evidence verification. Now they are asking for a valid OMB form (for local registration) after seeing the 510K provided by us.
I'm asking about the OMB form usage only, since it's new to me. If its not effecting the 510K, then sounds good to me.


(ii) where are you seeking regulatory approval! If the auditor is still insisting to use the Latest Version of 'Indication for Use Statement' form then use this link to download it. Remember your browser won't show the content of the PDF, you will need to download it first and then open it to fill it up.
- Yes, we are also checking with the local auditor on this concern on this OMB form validity. Yet to receive any response.
- Unfortunately, the link is not working for me, still thank you for being helpful on this.

https://www.fda.gov/media/124401/download[/QUOTE]

 

[monoj mon]

I'm asking about the OMB form usage only, since it's new to me. If its not effecting the 510K, then sounds good to me.

I don't think it will affect your 510(k)

- Unfortunately, the link is not working for me, still thank you for being helpful on this.

Have you seen something like this! If so then you will need to download the form first in order to view it.

 

[Murni Ahmad]

Hi there.

I had it downloaded, but the same document seen. Maybe my adobe reader is not up to date.

I check through the link above, nothing on the 0910 related to medical device found.



Still waiting for our local NB justification on this request to date.


By the way, I did go through the FDA website, they have very good learning material, but I couldn't find anything on this OMB 0910.0120.
Also, they still using flash for the media, flash EOL end of last year, hopefully, FDA revises and come back with a new media format soon.

 

[monoj mon]

Maybe my adobe reader is not up to date

Adobe Acrobat Reader DC Install for all versions
Download the adobe acrobat reader from here.

I check through the link above, nothing on the 0910 related to medical device found.

This is because, the forms are identified by the FDA Form number, not by the OMB numbers. The OMB No. 0910-0120 belongs to the FDA FORM 3881 (Indications for Use).