FDA PRE-SUBMISSIONS

The US Food and Drug Agency (FDA) strongly recommends Pre-Submission process to request feedback on PMA applications, HDE applications, de novo petitions, and 510(k) Submissions, as well as to address questions related to whether a clinical study requires submission of an IDE.   The program was known as the pre-IDE process to provide feedback on future IDE applications prior to their submissions.  The scope of this program was extended to provide feedback on pre-market submissions.  These included providing advice to industry during the developmental stages of IDE, 510(k), PMA, HDE, IND and BLA submissions.  AltaQ will work with you to develop, submit, coordinate responses, and attend meetings as necessary.   

 

Each submission is assigned a unique Q-Submission number and response is provided  according to the following timelines:

Pre-Submission

Information Meeting

Study Risk Determination

Agreement Meeting

Determination Meeting

Submission Issue Meeting

Day 100 Meeting

Upon request

Yes

No

Yes

Yes

Yes

Yes

75 - 90 days

90 days

N/A

30 days or within time frame agreed to with sponsor

Date for meeting agreed upon within 30 days of request

21 days

100 days (from PMA filing date)

Q-Sub Type

The timeframe for meeting from receipt of submission

Meeting as method of feedback?

For more information and to learn how we can address your specific needs, please

CONTACT US

E-mail: info@AltaQ.com

1666 Connecticut Ave NW

Washington, DC 20009

Telephone: 301.263.0544

Fax:            509.694.9964