Lecture 4 - Regulatory Strategy and FDA Meetings

What is regulatory strategy?

A plan to bring a product to market in desired regions within desired timeframes.

What questions are part of regulatory intelligence?

Business objective, problem solved by product, competitor products, regulatory pathways competitors used.

What is a key quote about planning in regulatory strategy?

'If you fail to plan, you can plan to fail.'

What is Habit 2 from Covey that applies to strategy?

Begin with the end in mind.

What does a regulatory plan include?

Executive summary, target countries, regulatory landscape, pathway choice, project scope, deliverables, risks, submissions, inspections, quality compliance, health authority strategy.

What are project plan steps?

Determine milestones, gather regulatory data, get SME input, challenge assumptions, identify stakeholders, strategy buy-in, track deliverables, ensure compliance.

Key US regulatory strategy considerations: target and risk?

Identify target disease/population, assess patient safety and cybersecurity risks.

Key US regulatory strategy considerations: classification?

Determine if device matches classification panel, if de novo, clinical studies needed, IDE required.

Key US regulatory strategy considerations: device classes?

Class I: enforcement discretion; Class II: best 510(k) method; Class III: PMA requirements; breakthrough device program eligibility; GLP/GCP/GMP compliance.

Why confirm regulatory strategy with FDA?

Use Q-Submission program; revise strategy based on internal/external changes.

Four main types of FDA communication?

Administrative meetings, regulatory communications, product application meetings, public administrative proceedings.

What are administrative meetings?

Formal or ad hoc, private communication (email/phone/in-person), dispute resolution, public meetings.

What are regulatory communications?

Regulations in Federal Register (30-60 day comment), requirements in 21 CFR, guidance (90-day comment, nonbinding).

What is a citizen petition?

Formal request for FDA action; must include action requested, grounds, environmental/economic impact, certification; FDA responds in 180 days.

What meetings fall under product applications?

Q-Sub, presubmission, informational, risk determinations, early collaboration, submission issue requests, PMA Day 100, breakthrough designation.

Presubmission meeting timing?

Feedback in 70 days or 5 days pre-meeting; meetings ~60-75 days after request.

What should be in a presubmission package?

Cover letter, TOC, device description, intended use, prior submissions, development overview, specific questions, feedback method.

Key advice for FDA questions?

Avoid open-ended questions; ask direct, actionable ones like 'Does FDA agree with X, Y, Z plan?'

What are informational meetings?

Sponsor shares information with FDA.

What are study risk determinations?

FDA decides if product is SR (IDE required) or NSR (IDE exempt).

What are formal early collaboration meetings?

Agreement or determination meetings, 30-day timeframe, binding results on investigational plan and protocol.

What are submission issue requests?

Discuss premarket deficiencies; FDA grants within 21 days.

What happens at PMA Day 100 meetings?

FDA interim review, deficiency list, review timeline, advisory panel, pre/post-market requirements.

What is breakthrough device designation?

Request via Q-Sub; FDA responds in 60 days.

What happens during submission review communication?

RTA in 15 days, substantive interactions (address or hold), 510(k) in 60 days, PMA in 90 days, missed MDUFA communication.

What are public administrative proceedings?

Advisory panel, hearings, workshops, board of inquiry, informal/scientific reviews, evidentiary hearings.

Step 1 in FDA meeting prep?

Research personnel, precedents, guidance, anticipate positions.

Step 2 in FDA meeting prep?

Define goal (guidance, program presentation, agreement), align messaging.

Step 3 in FDA meeting prep?

Anticipate questions, prepare drafts, identify data interpretation differences, anticipate opinion shifts.

Step 4 in FDA meeting prep?

Send materials early, draft agenda.

Step 5 in FDA meeting prep?

Assemble the right team.

Step 6 in FDA meeting prep?

Practice the meeting.

How to manage the FDA meeting?

Stay on time, focus on goals, guide discussion, seek clear commitments.

What cues to listen for from FDA?

Tone, body language, offhand remarks, avoided topics, muted calls; correct misinterpretations immediately.

How to document FDA feedback?

Submit minutes, track raised issues, note repetition, summarize and confirm discussion.

How to maintain FDA relationship?

Be collaborative, flexible, composed, respectful, not adversarial.