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

Agenda
• 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

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 intended
purposes 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

De Novo 510(k)
• 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) Database

PMA Database

Step 3: Determine Specific Regulatory
Requirements Review
• 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 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

Regulatory Discussions Why?
• 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 – 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

Regulatory Discussions – How?
• 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

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
REHEARSE
REHEARSE

SUMMARY
• 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

THANK YOU
Contact: www.bos TCN Life Science Fast Track 2014 11/18/2014ton-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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