March 28, 2006

1
Pamela J. Weagraff Principal Consultant
Combination Products Preparing for the
Journey March 28, 2006
2
Combination Products Preparing for the Journey

• Consider and understand the law, know the
  regulations, make use of available resources -
  why is obvious to understand how your product
  will be regulated but what about . . .
• When in earliest phase of product development as
  part of establishing Regulatory strategy
• Where and Who Office of Combination Products -
  Mark Kramer, Director, and staff, of Center
  Jurisdictional Offices
• What and How Office of Combination Products web
  site, http//www.fda.gov/oc/combination

3
Preparing for the Journey When?

• First Phase of Product Development - Regulatory
  Strategy assignment to a center with primary
  jurisdiction, or a lead center, is based on a
  determination of the primary mode of action
  (PMOA) of the combination product develop . . .
• A brief description of the product and its major
  components, intended use of the product,
  (clinical/therapeutic claims, including patient
  population)
• An explanation of the products modes of action
  (how the product works) which mode of action is
  primary and attributable to device, drug or
  biologic
• Consider need for formal or informal request for
  designation

4
Preparing for the Journey When?

• Informal or Formal Request for Designation (RFD)
  consider . . .
• Known FDA experience with similar products,
  established precedents suggests informal RFD
• Mitigation of business risk or lack of similar
  products suggests formal RFD

5
Preparing for the Journey Where and Who?

• Establish a relationship with the Office of
  Combination Products Staff
• Assignment of combination products to Product
  Assignment Officer or Director
• Regulatory identity of a product as a drug,
  device, biological product, tissue (HCT/P) or
  combination product to Product Classification
  Officer or Director
• Premarketing or post-marketing issues, including
  requests for facilitation or guidance to either
  the Associate Director or the Senior Scientific
  Advisor
• General policy or regulatory issues to Director
  or Associate Director

6
Preparing for the Journey Where and Who?

• Establish a relationship if you are reasonably
  certain of designation, questions can be directed
  to Center jurisdictional offices
• CBER Sheryl Lard-Whiteford, Ph.D., 301-827-0379
• CDRH Eugene Berk, 240-276-0104
• CDER Warren Rumble, 301-443-5581

7
Preparing for the Journey What and How?

• Apply the OC Resources Informal RFD
• Contact either OCP or Center Jurisdictional
  Office
• Present information developed as part of
  Regulatory Strategy
• Brief description of the product / major
  components, intended use, (clinical/therapeutic
  claims, including patient population)
• Explanation of modes of action (MOA) (how the
  product works) which MOA is primary and
  attributable to device, drug or biologic
• Request feedback on center assignment

8
Preparing for the Journey What and How?

• Apply the OC Resources Formal RFD
• Determine proceeding directly to RFD or
  submitting Pre-RFD
• Contact OCP Director
• Discuss plan for Pre-RFD and RFD or proceeding
  directly to RFD, provide Regulatory Strategy
  information
• Request feedback on plan
• Develop Pre-RFD or RFD according to OCP Guidance
  How to Write a Request for Designation, August
  2005, contact Leigh Hayes, OCP, 301-427-1934

9
Preparing for the Journey What and How?

• Pre-RFD or RFD
• Follow the guidance document contact Leigh
  Hayes, OCP, 301-427-1934, with any questions
• Logistics
• Electronic submissions accepted
• OCP review for completeness 5 days
• If complete per regulation / guidance,
  distributed to qualified individuals in Centers
  for review
• OCP RFD review 60 days

10
Were off and assigned . . .

• Now what?

11
Ask Questions, All of Them!

• What good manufacturing practice regulations
  apply to combination products?
• How are adverse events reported for combination
  products?
• How will user fees for our combination product be
  applied?
• What kind of safety and effectiveness information
  will be needed to support approval of our
  combination product?
• How can master files can be used in the
  submission of information relevant to our
  combination product?

12
Work the Relationship with OCP

• Include OCP staff in meetings with designated
  Center personnel for Pre-IND or Pre-IDE meetings,
  cc on submission cover letter
• Keep OCP staff apprised of project status and
  request assistance in event of disputes, informal
  or formal
• Become VERY familiar with the OCP web site

13
Chance favors the prepared mind.--  Louis
Pasteur

• Thank you!
• Pamela J. Weagraff, MBA, RAC
• Principal Consultant, Medical Device Development
• Quintiles Consulting
• Tel [phone]
• E-Mail pamela.weagraff_at_quintiles.com