FDA Compliance Help Desk, Inc.

FDA 510K SUBMISSIONS

Fast — Effective — Affordable

When it is time for the FDA 510K submission, you want it to be done as quickly as possible.  The longer a FDA 510K submission drags out the more sales are either delayed or lost.  We assure your new product hits the market without delay and with the right claims.  The cost of hiring us is more than offset by the benefit of getting to market faster with the claims that will drive sales. Our FDA 510K submission services include:

1. Verification that the predicate device claims are consistent with the claims for the product being submitted. 
2. Research the applicable FDA regulations, guidance documents and previously filed documents. This research is a key component to a prompt release to market.
3. Maintain a dialog with the lead reviewer—
   • to obtain clarification regarding deficiencies cited in a formal hold letter; 
   • to reconcile any disagreement with a deficiency cited by a reviewer during a review cycle; 
   • to inquire whether a new timeframe may be given to provide addition information requested during a review cycle because the initial timeframe cannot be met;
   • to discuss procedural questions related to the submission;
   • to clarify information in the submission that is unclear;
   • to request or schedule a meeting; or
   • to alert FDA that we intend to submit additional information and get a reading form the lead reviewer that the data is completely satisfactory. 
4. Assist in the preparation and review of the FDA 510K submission.
5. Prepare the final 510K application (or amendment) for submission to the FDA.
6. Assist with the preparation of a response if the FDA has questions or requires additional information.
7. Act as the official correspondent on the application and remain accessible to the FDA for any future discussions regarding the 510k submission. 
8. Provide phone consultation during the FDA 510K application.

To facilitate a timely release to market we will:

• Use best reasonable efforts to assure the submission is complete consistent with applicable regulations, recommendations in the available guidance documents, and communications with FDA prior to submission;

• provide complete contact information in its cover letter (i.e., name, email, phone number, fax number) accompanying each formal submission;

• apply appropriate material or testing standard(s) and submit the necessary declarations or data to support the use of the standard(s);

• provide a complete response to all deficiencies communicated informally during a review cycle within the FDA-allotted timeframe; and

• provide a complete response to all deficiencies cited within the specified timeframe in the event the FDA issues a hold letter, including reasons for responding in a different manner from that requested by FDA.

We are a dedicated group of experienced professionals, your new product submission is never relegated to a trainee.

Our engagement terms are flexible and simple.  Most clients prefer our affordable hourly fee option.

If you prefer a flat fixed fee, please include that preference in your request.

Click Here to Request A Quote

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Call us toll free: 1-888-299-0157    International callers: 1-919-942-1634

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FDA Compliance Help Desk™

1289 N. Fordham Blvd. Suite A-128

Chapel Hill, NC 27517 USA

Phone 919.942.1634

info@FDAcomplianceHelp.com

Copyright © 2004 - 2009 FDA Compliance Help Desk, Inc.
Last modified: October 16, 2008

FDA Compliance Help Desk, Inc. is a for profit NC corporation and is not affiliated with the U.S. Department of Health and Human Services.