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FDA Homepage Food Drugs Medical Devices Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Combination Products

Combination Products I would usually include a “Resources for You” section here, with a list of
1 specific audiences. However:
Combination Products Most Popular o This topic has only one audience, industry
About Combination Comment on the o The audience does break down into specific types – pharmaceutical
Products
1 “Report a Problem” manufacturers, device manufacturers, and academic researchers, to name
procedure three
Safety Image Comment on the o But their information needs do not differ.
2
application procedure So there is no reason to specify different audiences.
Jurisdictional
Information I pulled this from the “What’s New” section of the current Combination
3 2 Products site. Ideally, you would have something more recent, and text that
RFD Process Report a Problem highlighted the combination aspect of the product. This is just an example.
2
Transdermal Patch for Treatment of Parkinson's Disease Approved
Guidance & Regulatory On May 9, 2007, The U.S. Food and Drug Administration (FDA) today Product Approvals
Information There is a standard button for “Recalls & Alerts” but I did not see any data of
announced the approval of Neupro (rotigotine transdermal system), a 3
skin patch designed to treat symptoms of early Parkinson's disease.
that type on this site. I am adding this comment so you know about the button,
Requests for Comment should you need it in the future.
LEARN MORE Related Reports &
News & Events
Articles 5 4 Because there is just one audience, I needed to put something else here.
About Combination Products Request for Designation (RFD)
Examples, Questions about Process - Report to Congress: OCP
Combination Products How to Write an RFD, Questions about Performance Report for
I didn’t have anything for the Tools & Resources modules, because there are
RFDs 2006 5
Jurisdictional Information no online tools. So I adapted the “Related Resources” module.
Jurisdictional Transfers, Request Guidance & Regulatory Information - Article: “Combination
for Designation (RFD) Regulation Overview, Enabling Act, Products: Challenges and
Jurisdictional Decisions Acts, Rules & Regulations, Guidances Progress” (Regulatory Affairs
1 Focus Magazine, 8/05)

News & Events - Editorial: “FDA’s Office of

Combination Products:
2/08 Office of Combination Products (OCP) Review Roles, Progress &
Performance Updated challenges” (Journall of
Medical Dvice Regulation, 8/
3/07 Combination Product Approved: Absorbable Collagen 05)
Sponge with Genetically Engineered Human Protein

2/07 Guidance: Devices Used to Process Human Cells,

Contact Us
Tissues, and Cellular and Tissue-Based Products
301-427-1934
(HCT/P’s)
More News Items...
combination@fda.gov

Regulatory Information
Final Rule: Definition of the
Primary Mode of Action of a
Combination Product (Federal
Register, 8/25/05)
Definition of a Combination
Product from 21 CFR § 3.2(e)
Final Rule: Assignment of
Combination Products/Product
Jurisdiction Program (6/23/05)
4 Office of Combination
Products
Jurisdictional Updates 15800 Crabbs Branch Way
(HFG-3), Suite 200
Rockville, MD 20855
Breath Test Combination
Products (9/06) Media Inquiries
Minimal Manipulation of About OCP
Structural Tissue (9/06) [pdf file,
49KB]
Heparin Catheter Lock-Flush
solutions: Transfer from DCER-
CDRH (9/17/06) [pdf file, 51KB]

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