Life Science Fast Track - Regulatory Strategy

Regulatory Strategy 101

Mack D. Rubley, PhD

Vice President, Consulting Services

What is “Strategy”

TCN Life Science Fast Track 2014 11/18/2014

• Regulatory Pathway to Market Clearance

– Discuss Strategy of Product Approval

• Pre-market Plan

– Present tools - “How to use the FDA databases”

• Product Classification

• Product Codes

• 510(k) Database

• PMA Database

• Regulatory Discussions with FDA: Pre-Submission

Agenda

11/18/2014TCN Life Science Fast Track 2014

Regulatory Pathway to Market Clearance

Balance Between Market and Regulatory

• Considerations

– Territory

– Disease prevalence

– Cost to obtain approval

– Cost/burden to maintain approval

– Investor/stockholder expectations

Balance Between Market and Regulatory

The Balance –Successful and Timely Product Introduction

Developing the Plan

• Market approval regulations

– Testing requirements

– Labeling requirements

• Vigilance requirements

• Standard reporting requirements

• Summarize the requirements in a document for your regulatory “play book”

Pre-Market Regulatory Planning

The Pre-Market Regulatory Planning

1. Determine product categorization

• Drug, Device, Biologic or Combination Product

2. Determine: Device type of submission

• PMA vs. 510(k)

3. Develop appropriate submission strategy

• Pre-submissions?

• Pre-meetings with regulators?

4. Consider potential for reimbursement

Step 1: Product Categorization – Medical Device

A medical device is

“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

– recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

– intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

– intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intendedpurposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

Difficult to Determine?

• Combination products – Request for Determination (RFD): Section 513(g)

• Formal Request for Determination

– Based on Primary Mode of Action (device, drug or biologic)

– Establishes the “primary” review division for the product

– Will likely have a “co-review” by another division

• Guidance document available:

– “How to Write a Request for Designation (RFD)”

Step 2: Determine Appropriate Regulation –PMA or 510(k)?

• FDA product database search for similar products

– Utilize PRODUCT CODES and Regulations

– 510(k)

– PMA

• Review relevant 510(k) Summaries and PMA SSEDs (Summary of Safety And Effectiveness) for insight

• Review FDA guidance documents & Standards

Market Research

Product Code Classification Database

Guidance Document Page

Standards

510(k) Premarket Notification Database

• There are two options for de novo classification for novel devices of low to moderate risk.

• Option 1: Any person who receives an NSE determination in response to a 510(k) submission may, within 30 days of receipt of the NSE determination, submit a de novo request for the FDA to make a risk-based evaluation for classification of the device into Class I or II.

• Option 2: Any person who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may submit a de novo request for the FDA to make a risk-based classification of the device into Class I or II, without first submitting a 510(k) and receiving an NSE determination.

• “Is the de novo process right for my product?” If your product is:

1. a novel device (new intended use)

2. presents a moderate or low risk profile, and

3. no predicates exist (with the same intended use)

• This is conditional on your ability to provide the necessary evidence supporting the safety and effectiveness of the device, including the general and/or special controls which would provide a reasonable assurance of safety and effectiveness to the FDA.

De Novo 510(k)

De Novo 510(k) Database

PMA Database

• Market Research

• Product Codes

• Review FDA applicable guidance and standards documents

• Review relevant 510(k) summaries, and PMA SSEDs

• Couple the research with engineering expertise to develop a plan for engaging with the FDA

Step 3: Determine Specific Regulatory Requirements Review

Step 4: Reimbursement

• Evaluate current reimbursement options

• Currently available codes

• Considerations for CMS discussions

– Can coincide with potential FDA discussions

Regulatory Discussions with FDA: Pre-Submission

• Concern about product definition (drug/device)

• Outstanding questions on test plan

• Novel technology introduction

• Considerations:

• Non-binding

• Adds time to the process

• Pre-IDE submission

• Schedule of meeting

• Addressing input from FDA

Regulatory Discussions Why?

Regulatory Discussions – When?

• When there are outstanding questions that are costly

– Which animal model

– How many animals are appropriate

• When there is a novel clinical study design

– Adaptive trial design

– Utilizing an Objective Performance Criteria rather than an RCT

• When there is a challenge to a regulatory pathway

– Question regarding product as a 510(k) vs. PMA

• Contact review division chair

– Will likely connect you to a reviewer or project manager

• Prepare a formal Pre-Submission

– Written document including:

• Product description

• Proposed indication

• Proposed test plan and protocol summary

• Specific questions requiring FDA input

Regulatory Discussions – How?

Logistics

• Face to Face is ALWAYS best

• Establish a schedule for the preparation

• Hotel the evening before

• Schedule Prep sessions with experts

The Meeting Prep

• KNOW YOUR DIVISION

– FDA are people too

– Engage in science not sales

– Prepare for negotiation discussions

– Prepare for challenges from FDA – a good back up slide deck is vital

• Being over prepared will never be a problem

• Being under prepared can be devastating

The Meeting Plan

• Develop the key messages

• Assemble the RIGHT speakers

• Identify a scribe for minutes

• Brainstorm the Q and A

The Meeting Approach

• Approach discussion with confidence

– You are the EXPERT!

– “Guidance” from FDA not “Direction”

• Don’t be caught off guard

– Know your submission COMPLETELY

– Research competitive product challenges

– Understand the literature

• Pretend you are in the FDA’s shoes

• What would you worry about?

Ending The Meeting

• Review and confirm all Action Items

• Don’t leave the room without clear direction on a path forward

– Always say Thank You

The Meeting – cont’d

REHEARSE

• Strategy is borne out of experience and a co-operative team

• Research and discussions are key

• Understand your product and how it fits in the medical setting

SUMMARY

THANK YOUContact: www.boston-biomedical.com

Boston Biomedical Associates

www.boston-biomedical.com

info@boston-biomedical.com

Mack Rubley PhD

Vice President, Consulting Services

mrubley@boston-biomedical.com

508-691-704

Life Science Fast Track - Regulatory Strategy

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