Arch Therapeutics Inc (ARTH)

[Amatuer17]

Here is summary of the Steps in 510K approval process.

As you can see if application is clear and all documentation is in order, FDA can give approval in 90 days – which is really great. However there are multiple steps where application can go on hold and then company will need to submit the information.

One of the key milestone is – DCRH accepting the application – this will happen in 15 days. I think this is material even and company will have to inform SH if the application is not accepted and put on RTA hold.

I hope company follows this and updates us on progress.

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Step 1 (day 1) - 510k Submission – electronic filing and pay proper user fee

Step 2 (By day 7) - Center for Devices and Radiological Health (CDRH) issues the acknowledgement of the application confirming that the application was received and is in order. (7 days from receipt of electronic application)

Step 3 (by day 15) - DCRH sends the Acceptance Review results within 15days of step 2 electronically. It can have 3 results

a. accepted for substantive review
b. not accepted for review
c. under substantive review because FDA did not complete the acceptance review within 15 calendar days.

Step 4 – If application is not accepted for review – it is put on RTA hold. Company has 180 days to address the deficiencies in the hold else the application is considered after 180 days.

Step 5 (by Day 60) – FDA conducts Substantive Review of the application

- Inform if application on hold asking more information

- Inform if the Interactive review process for decision

Step 6 (by day 90) - MDUFA decision conveyed to the company

If FDA misses the 90 day deadline – they will inform company by day 100 the items under review and issues if any.

The day 90 does not include the applications going on hold in step 3

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