From: Michael.Gross@aventis.com Sent: Friday, November 15, 2002 12:12 PM To: mkramer@oc.fda.gov; FDADockets@oc.fda.gov Subject: Notification of intent to participate and present at the Part 15 Public Hearing on Combinaton Products Dear Mark, Pursuant to out telephone call yesterday I am writing to inform the Agency of my desire to make a 10-15 minute presentation at the Part 15 hearing on November 25, 2002. The comments that I plan to present will mainly address questions 1 and 5 in the FR notice. You indicated that I would be able to present at the meeting if I notified you today. Please respond to this message with an email to both my work at michael.gross@aventis.com AND to my home at michaelgross@comcast.net with a time for my presentation. The Intercenter Agreements are agreements between the Centers allowing the sharing of regulatory authorities. They should continue to focus only on jurisdiction. By providing examples they provide guidance. Since there are many types and sub-types of combination products it is not possible to address every possibility in the Intercenter Agreements. The examples provided should be used to establish principles. The Intercenter Agreements need some minor updating because some of their examples are arguable (which could cause problems for products that fit these examples), but they are useful documents. However, FDA should issue separate guidance on each of the regulatory issues that are derivative of the assignment of jurisdiction, many, but not all of which are identified in the FR notice. The question of the structure/design of a quality system for a combination product is not that complicated. What is important is that FDA and the industry are in agreement so surprises during inspection are avoided. Depending on the type or subtype of a combination product appropriate quality system structures can be envisioned that are either separate, linked or integrated. In this regard, Design Controls (previously known as pre-production quality assurance) which is codified in the QSR may be a useful tool regulating of all types of combination products. Michael Gross, Ph.D. Vice-president Worldwide Compliance Aventis Behring 1020 First Avenue P.O. Box 61501 King of Prussia, PA 19406-0901 USA Work phone: 610-878-4490 FAX: 610-878-4461;610-878-4603 Administrative Assistant: Annette Meertz, 610-878-4113