Best Practices for Preparing and Conducting Pre-Submission Meetings
•
0 likes•434 views
This presentation covers everything you need to know about Q-Subs, how to create the best packet possible, common pitfalls, strategies for conducting pre sub meetings, and observed differences between divisions. This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Recommended
Recommended
More Related Content
What's hot
What's hot (20)
Similar to Best Practices for Preparing and Conducting Pre-Submission Meetings
Similar to Best Practices for Preparing and Conducting Pre-Submission Meetings (20)
More from Greenlight Guru
More from Greenlight Guru (20)
Recently uploaded
Recently uploaded (20)
Best Practices for Preparing and Conducting Pre-Submission Meetings
- 1. FINALLY, A NEXT-GEN CRO Dedicated to the New Class of Rising Stars in Drugs, Medical Devices, and Diagnostics 1
- 2. “Greenlight Guru Software is the handrail for Medical Device Development and Documentation” FEATURED IN 75 years industry experience 275k podcast listeners #1 blog and podcast in the industry 90k look to us for the latest in medical device quality MEDICAL DEVICE QUALITY IS ALL WE DO, AND WE’RE ALWAYS AHEAD OF THE GAME. “My QMS is world class” “One stop shop for MDQMS”
- 3. 3 Speaker Info Isabella Schmitt, RAC Proxima Clinical Research, Inc. Tel: 404-205-4653 E-mail: Isabella@proximaCRO.com Don’t hesitate to reach out!
- 4. 4 Navigating Q-Submissions Agenda 1 2 7 5 3 4 6 Introductions What’s a Q-Sub? Types of Q-Subs Pre-Submission Meetings Additional Q-Sub Types Breakthrough Device Questions
- 5. What’s a Q-Sub? 5 From ancient times (1995) to modern day, early interactions with FDA have been evolving 1 Way to interact with FDA prior to formal submission Will get a Q number (Q followed by six digits) 2 All subsequent interactions will be tracked by the Q; also allows for linking market submission 3 4 Not intended to be used for the same topic multiple times Outline expected submissions if possible 5 Can’t be withdrawn once feedback is obtained 6
- 6. What’s a Q-Sub? 6 From ancient times (1995) to modern day, early interactions with FDA have been evolving 1 Original: First submission Supplement: New request for feedback/meeting 2 Amendment: Additional info that is not request for feedback or meeting 3 Q+ 2 Digits for year +4 digits for order in which request was received e.g. Q190001 Original Q number +/S### for each supplement e.g. Q190001/S001 Original Q Number + /A### e.g. Q190001/A001
- 7. 7 Types of Q-Subs Pre-Submission Meetings (60-90 days) Written Feedback (70 days, or 5 days prior) Informational Meeting (Standard 90 days) Breakthrough Device (60 days, interaction at Day 30) Submission Issue Requests (<60 days, 21 days >60 days, 70 days) Study Risk Determination (Written Feedback- 90 days)
- 8. The General Contents 8 ◆ Cover letter ◆ Company name, address, contact person and contact information ◆ Optional but recommended Form 3514 ◆ Q-sub Type ◆ Meeting/Feedback details ◆ Purpose ◆ Device Description ◆ Proposed Intended Use/Indications for Use ◆ Regulatory History
- 9. Meeting Details 9 Time Discussion Topic 5 mins Introductions 10 mins Presentation 35 minutes Discussion 10 mins Session close and summary of responses/action items Meeting Type: Preferred dates & times: Suggest 3 Planned attendees: Your team, consultants, any external stakeholders (CMS, NIH grant reviewers, etc.) Audiovisual requirements: Phone? Projector? Internet access (request 5 days prior)? Agenda Method for Feedback
- 10. Pre-Subs are a section of the FDA Q-Sub program. They are a voluntary opportunity to obtain FDA feedback prior to an intended submission. Manufacturer submits a formal written application FDA feedback is provided in a written response Applicants may also request a face-to-face meeting
- 11. Smoother review process Enhanced transparency of the review process Improved quality of subsequent application Potentially shorter total review times No fees
- 12. “Pre-subs” 12 The most commonly discussed Q-subs Am I too early? What topics can I discuss? Where does the pre-sub occur? Do I need a pre-sub? Can I just e-mail FDA my questions?
- 13. “Do I need a pre-sub?” 13 ◆ Voluntary ◆ No user fees ◆ Obtain feedback from FDA prior to application It’s smart… Unless your path is obvious
- 14. “Am I too early?” 14 You’re not too early… Unless you are. ◆ Can occur at any stage in development ◆ The sooner, the better! ◆ As long as you’re ready to defend what you present
- 15. “What topics can I discuss?” 15 Anything you want within reason ◆ Regulatory Pathway ◆ Novel device, no established pathway ◆ De Novo, no product code, no predicate ◆ Note that final determinations made at time of submission ◆ Bench Testing ◆ Unusual testing methods ◆ Worst-case scenario ◆ Sample size and power analysis ◆ Justification for not conducting certain studies ◆ Animal Studies ◆ GLP study design address device potential risk ◆ Animal model appropriateness ◆ Clinical Studies ◆ Questions about OUS protocols ◆ Endpoints ◆ Study size
- 16. “Where does the pre-sub occur?” 16 ◆ In writing ◆ Teleconference ◆ In-person: Silver Spring, Maryland
- 17. “Can I just e-mail FDA my questions?” 17 ◆ Need context ◆ Provide a uniform front ◆ Time to review Short answer: No.
- 18. Pre- Sub Briefing Packet 18 Length and content depends on intent of meeting ◆ Device description ◆ Principles of operation ◆ Key components ◆ Intended use ◆ Patient population ◆ Testing plan ◆ Non-clinical ◆ Clinical
- 19. Questions 19 Make sure you ask targeted questions ◆ What are the objectives for the meeting? ◆ Specific and lead the FDA to the answer ◆ Reference guidances, standards, guidelines ◆ Make sure to provide adequate context in the question and briefing packet
- 20. Given that the intended use is the same as the predicate and technological differences do not raise new questions of safety and effectiveness, does FDA agree with the proposed predicate device? Given that there is not a currently marketed device that can serve as predicate under the 510(k) pathway, does FDA agree that a De Novo request is appropriate? Based on the regulatory strategy provided, does FDA agree that additional clinical data is not needed for a future 510(k)?
- 21. Does FDA agree that our software/instrument is a moderate level of concern and that the level of documentation that will be included in an upcoming marketing submission is consistent with FDA’s recommendations as part of the upcoming device submission? Does FDA agree that the software documentation does not need to be included in the PMA supplement for the device as it was previously reviewed and approved in other PMA supplements?
- 22. Does FDA concur that the revised GLP Study design is sufficient to address potential device risks and support initiation of a pivotal clinical trial? Given the similarities in vasculature, does FDA agree that the animal model proposed appropriate based on the proposed intended use?
- 23. Does FDA agree that the provided OUS study protocol is sufficient to address safety concerns in order to open a future US IDE? Does FDA agree that the patient population in the trial is representative of the patient population in the indications for use? Are the primary and secondary analyses appropriate for the Indications for Use for the monitoring indication proposed?
- 24. Pre-Sub Timeline Timelines may vary, but generally occur within a certain timeframe 24 Submission of packet to FDA Day 15: Acceptance Review FDA reaches out to schedule meeting dates Day 30: Meeting scheduled 5 days prior: Written feedback 30 days post: FDA gives feedback on minutes Day 60-90: Meeting Held 15 days post: Sponsor submits minutes 15 days after FDA Feedback: Minutes Finalized
- 25. •Provide several options for meeting dates •Confirm meeting details with RPM: o Set up a phone line for tele-conference o Confirm attendees and agenda •Prepare presentation: o Identify meeting topics, questions based on the FDA feedback o Send to FDA at least two (2) business days prior to meeting
- 26. DO DON’T ✔ Limit the meeting to 1 hour unless requested in a Pre-Sub ✔ Allow time for discussion ✔ Take detailed notes ✔ Ask for clarification ✔ Summarize action items at the end of the meeting × Expect FDA to act as a consultant × Expect FDA to clear, approve, or license a device at the meeting × Send new questions or discussion topics at the last minute
- 27. 27 Informational Meetings ◆ Share information ◆ No expectation of feedback ◆ Overview of product development ◆ Introduce a new device ◆ Catch-all ◆ E.g. MDDT, study design for NSR study (not intended for marketing submission) ◆ Feedback may be provided in these instances
- 28. 28 Study Risk Determination ◆ Non-significant risk ◆ TENS devices for treatment of pain ◆ Non-implantable bladder monitor ◆ EEG ◆ Significant risk ◆ Hemodialyzers ◆ LVADs ◆ Breathing gas mixers ◆ Exempt from IDE
- 29. 29 Submission Issue Requests ◆ To discuss issues with a submission (IDE, 510(k), PMA, HDE, De Novo) ◆ Used to quickly resolve issues/clarify issues to help move forward
- 30. SIR Briefing Packet 30 ◆ Specific questions ◆ Proposed plans ◆ Submit protocol
- 31. 31 Breakthrough Device Designation Things to Consider 1 Is the condition life-threatening or irreversibly debilitating? 2 Is the device treating or diagnosing? Prevention may be a policy flag. 3 Does it provide a more effective option than standard of care?
- 32. 32 Breakthrough Device: Criterion 1 ◆ “More effective” Treatment ◆ Compared to standard of care ◆ Realistic expectation of technical success ◆ Literature or pre-liminary data ◆ Life-threatening ◆ Likelihood of death is high if left untreated ◆ Irreversibly debilitating ◆ Substantial impact on day-to-day ◆ Progress to a more severe state if left untreated
- 33. 33 Breakthrough Device: Criterion 2 ◆ Breakthrough Technology ◆ Novel or novel use of existing technology ◆ Literature or pre-liminary data ◆ No cleared or approved alternatives exist ◆ Must have undergone pre-market review ◆ Typically reflect current SOC ◆ Scientific bodies, authoritative ◆ Indication specific
- 34. 34 Breakthrough Device: Criterion 2 ◆ Significant advantages over cleared or approved alternatives ◆ Reduce/limit hospitalization, provide safer operation ◆ Improve quality of life or early diagnosis/detection ◆ Allow for patients to manage own care ◆ Prevent or improve treatment-related side effect or eliminate side-effect of current care ◆ Best interest of the patients ◆ Additional public health benefit (wide scope IVDs) ◆ Avoids serious harm associated with another therapy that may cause discontinuation of the therapy
- 35. Example of Breakthrough Designations 35 Company Device Utilization Second Sight Medical Products Inc Orion Cortical Visual Prosthesis System Brain implant for patients with blindness caused by damage to the optic nerve. Mimics the perception of light through a miniature video camera worn by a patient that transmits signals to an implant in their visual cortex Early interaction meant that specialists across disciplines such as ophthalmology and neurology, representing the sponsor and FDA, could pose questions and solve problems. No standard way to evaluate the benefits or risks of a device like the Second Sight Orion; FDA was able to work with company to determine a way to measure the benefits/risks.
- 36. 2450 HOLCOMBE BLVD. HOUSTON, TX 77021 281.686.2744 www.ProximaCRO.com