Redacted Agency
Decisions on Requests for Designations
The Agency believes it is very important to provide robust transparency
in jurisdictional decision making. Such transparency should result in greater
predictability and consistency of decisions, and decrease ambiguity and uncertainty
about Agency perspectives. Moreover, as the basis for Agency decision making
becomes clearer, the need for formal Requests for Designation (RFD’s)
and informal inquiries covering the jurisdiction for specific products may
be diminished, which should help to conserve resources for both industry and
the Agency.
To this end, once the product covered by an RFD has been approved or cleared,
the Office of Combination Products (OCP) will ordinarily post on this website
its written jurisdictional determination respecting the RFD, redacted to remove
trade secret and confidential commercial information in accordance with the Freedom
of Information Act.
It should be noted that, in some cases, products undergo changes in name,
sponsor, design or other key aspects following FDA’s issuance of an RFD
decision. FDA will post RFD decision letters when it can be sure that the covered
product has been approved or cleared, but it should be recognized that the
posting may be incomplete. OCP will continue to post RFD decision letters as
it becomes aware that products covered by past decisions have been approved
or cleared.
PDF documents may
be read with a free copy of Adobe Acrobat Reader
- RFD 1992.004 -- Photofrin System [PDF 87KB]
- RFD 1992.012 – SonoRx [PDF 49KB] [Text]
- RFD 1992.013 – Compound Benzoin Tincture [PDF 43KB]
- RFD 1992.015 – Gliatech [PDF 42KB]
- RFD 1992.019 – GenESA Arbutamine Injection System [PDF 74KB]
- RFD 1992.020 – ARTZ [PDF 47KB]
- RFD 1992.029 – Pulse Spray Injector [PDF 54KB]
- RFD 1993.004 – Photophoresis System [PDF 94KB]
- RFD 1993.009 – Alprostadil with Self-Injection System [PDF 65KB] [Text]
- RFD 1993.015 -- Viringe Catheter Flush Device [PDF 64KB] [Text]
- RFD 1994.001 – Intestinal Permeability Test System [PDF 62KB]
- RFD 1994.015 – 13C-Urea Breath Test [PDF 112KB]
- RFD 1994.016 – Lidocaine-Epinephrine Iontophoretic Drug Delivery
System [PDF 78KB]
- RFD 1995.002 – LiDCo Indicator Dilution Cardiac Output System [PDF 75KB]
- RFD 1995.003 -- Prefilled Fentanyl Delivery System [PDF 69KB]
- RFD 1995.014 – SmartMist™ Asthma Management System [PDF 74KB]
- RFD 1995.015 – Tissue Bone Matrix™ Sponge [PDF 375KB]
- RFD 1995.023 -- AxSym™ Hepatitis Test Kits [PDF 69KB]
- RFD 1996.006 – ProCount™ Progenitor Cell Enumeration Kit [PDF 85KB]
- RFD 1996.010 – TheraSphere® Administration System [PDF 77KB]
- RFD 1996.014 -- Hemostatic Agent [PDF 72KB]
- RFD 1996.016 – 13C-Urea Blood Test [PDF 95KB]
- RFD 1996.019 – RESPIFLO Sterile Water for Inhalation Therapy [PDF 87KB]
- RFD 1996.020 – RESPIFLO/S Sterile Water with Saline for Inhalation
Therapy [PDF 87KB]
- RFD 1996.029 – STELLer™ CD34+ Test Kit used with IMAGN® 2000
Instrument [PDF 58KB]
- RFD 1996.032 – HIV-1 Urine EIA Test Kit [PDF 90KB]
- RFD 1997.005 – Sorbastace [PDF 65KB]
- RFD 1997.006 -- Vitros Hepatitis Immunodiagnostic Kits [PDF 97KB]
- RFD 1998.002 – Atrisorb-D Barrier Kit [PDF 85KB]
- RFD 1998.003 – Breath ID Test Kit [PDF 91KB]
- RFD 1998.008 – Nupro® Prophy Paste with Fluoride and Triclosan
[PDF 90KB]
- RFD 1998.018 – Sealouette™ Sealant Applicator [PDF 87KB]
- RFD 1998.022 – FibriJet Surgical Sealant Applicator [PDF 88KB]
- RFD 1999.004 -- Diagnostic for Glucan in Blood [PDF 77KB]
- RFD 1999.009 – Seal & Protect™ Protective Sealant for Exposed
Dentine [PDF 93KB]
- RFD 1999.014 – Wound Dressing [PDF 91KB]
- RFD 1999.015 – Nupro® Prophy Paste with Fluoride and Triclosan
[PDF 85KB]
- RFD 2000.006 – Sirolimus-Coated BX VELOCITY™ Balloon-Expandable
Stent [PDF 96KB]
- RFD 2000.009 – Trypan Blue Ophthalmic Surgical Marker [PDF 350KB]
- RFD 2000.023 – PEGASYS® (pegylated interferon alfa-2a) with COPEGUS
(ribavirin) [PDF 104KB]
- RFD 2001.004 -- Accessory to SynchroMed Infusion System [PDF 109KB]
- RFD 2001.006 – Paclitaxel-Eluting Stent [PDF 102KB]
- RFD 2001.016 -- Amniotic Membrane for Ocular Surface Reconstruction [PDF 118KB]
- RFD 2001.018 – DBX® [PDF 125KB]
- RFD 2001.020 – Allomatrix™ [PDF 119KB]
- RFD 2002.018 -- FloSeal [PDF 217KB]
- RFD 2002.031 – Blow Fly Larvae (Medical Maggots) [PDF 188KB]
- RFD 2002.038 -- Normocarb [PDF 457KB]
- RFD 2003.004c – MTAD Root Canal Cleanser Solution [PDF 118KB]
- RFD 2003.024 – pH Tampon [PDF 160KB]
- RFD 2004.013 – Decapinol® Oral Rinse [PDF 91KB]
- RFD 2004.014 -- ViziLite-Blue Oral Exam Kit [PDF 159KB]
- RFD 2004.016 -- Colloss E Bone Void Filler [PDF 95KB]
- RFD 2004.033 -- Wart Removal System
[PDF 117KB]
- RFD 2004.039 -- Innocor
[PDF 79KB]
- RFD 2004.042 – SPY™ Intra-Operative Imaging System [PDF 150KB]
- RFD 2004.053 – Epi-Max Impregnated Wound Dressing [PDF 131KB]
- RFD 2004.066 – Wound Cleanser [PDF 97KB]
- RFD 2005.003 – Sucralfate HCl Topical Paste [PDF 107KB]
- RFD 2005.005 – Misty™ Wound Treatment System [PDF 97KB]
- RFD 2005.009 – Urgotul® [PDF 129KB]
- RFD 2005.012 – Angiotech Antimicrobial Central Venous Catheter [PDF 145KB]
- RFD 2006.067 – Silvaklenz Skin and Wound Cleanser Solution [PDF 69KB]
- RFD 2006.068 – Skin and Wound Moisturizer Solution [PDF 47KB]