# Presentation: 580665

## TIPS/STRATEGIESON WORKINGWITH FDA/OIVD

- Cathy Craft
- 510(k) Workshop
- April 18 – 19, 2006

## TOPICS FOR TODAY’S DISCUSSION

- Interaction Opportunities and how to handle each
- Preparing a Submission
- The why’s and how’s of Meetings with the FDA
- How to handle disagreements

## OIVD INTERACTION OPPORTUNITIES

- “Opportunities” because they’re truly your best way to build _good_ rapport.
- Prior to submission
- Submission
- Post-Submission
- Impromptu Events

## INFORMAL PRE-SUBMISSION INTERACTIONS

- Informational
- If needed to clarify OIVD regulatory position on your type of product
- If needed to clarify OIVD clinical trial requirements for your type of product
- But remember – choose the number and frequency of your informal communications carefully.  The FDA doesn’t replace your regulatory staff or advisors.  If you need specific information, request a formal meeting.

## FORMAL PRE-SUBMISSION INTERACTIONS

- 513(g) – Request for Classification
- Know your product’s regulatory status and classification before you invest time and resources
- Pre-IDE
- Formal feedback from OIVD on your clinical trials plan and submission strategy

## PRE-SUBMISSION INTERACTION DECISION TREE

- #1

## PRE-SUBMISSION INTERACTION DECISION TREE (cont.)

- #2

## PRE-SUBMISSION INTERACTION DECISION TREE (cont.)

- #3

## SUBMISSION

- IDE
- IVD’s are usually exempt from IDE unless results are going back to physician or patient and are used to determine treatment.
- 510(k)
- Class II products
- PMA
- Class III products

## PREPARING A SUBMISSION

- Remember, it may be your first, or most lasting, impression.
- Make it clear, neat, well-organized, and numbered.
- Proofread!!!
- Have an individual outside of the preparation group review before sending (clarity, typos, etc.)
- Deliver or mail; receipt or no receipt.

## THEY’VE AGREED TO MEET -THE MEETING PREPARATION

- Decide what your meeting objectives are.
- Prepare an agenda around your objectives.  Provide it to the FDA in advance so they have time to review it.
- Plan your presentation for time allotted, leaving time for questions and discussion.
- Have your questions ready.
- Do a practice run of the presenter(s) and presentation.

## THEY’VE AGREED TO MEET -THE MEETING ITSELF

- The Three B’s:
- Be Prompt
- Be a Good Listener
- Be Non-Defensive
- Have a designated note-taker
- Communicate your goals clearly, but be willing to compromise.
- Offer to follow-up on questions you cannot answer; then do it.

## THEY’VE AGREED TO MEET -AFTER THE MEETING

- Send a letter to OIVD with the minutes and any requested information.
- Follow-up with OIVD on the minutes to ensure no miscommunications.
- Reach agreement with OIVD on next steps.
- Don’t promise what you can’t do, then do what you promised.

## How to Disagree	

- Respect the chain of command; talk directly to the person with whose opinion or decision you disagree.
- If not resolved, go to the next level.  Let the first person know in advance and offer to keep them involved.
- Science questions stay within the Division or Office.
- Policy questions are typically elevated to the Office.
- Know when to involve the ombudsman, e.g. playing field issues.

## PHONE CALLS

- For submission follow-up, wait an appropriate time; but it’s a balancing act between checkingand nagging.
- Prepare for the phone calls.
- Have an objective.
- Have the right people present.
- Designate a note-taker.
- Try to avoid cell phones.

## POST-MARKET INTERACTIONS

- Includes conditional approval follow-up, inspectional issues, product problems.
- Conditional approval follow-up: appropriate OIVD Division.
- Inspectional issues follow-up: district office
- Respond promptly with correctional plan and timeline.
- Provide updates at promised timepoints.
- Contact OIVD Division if pre-market issues are questioned.
- Product recalls: district office
- Medical Device Reports: FDA CDRH

## IMPROMPTU EVENTS

- If your product is in the regulatory grey zone, don’t wait until you receive a letter from OIVD to develop the working relationship.
- Be respectful of the occasion and time.
- Don’t button-hole an OIVD person at an open meeting and discuss confidential issues.

## IN SUMMARY

- Be respectful
- Stay calm
- Plan, Plan, Plan
- Follow-up in a timely manner on your promises.