Jurisdictional
Determinations
FDA has received requests for more information on the Request for Designation (RFD) process. The RFD process is used to obtain a formal agency determination concerning which agency component will have lead responsibility for the premarket review and regulation of a combination product[1] , or for a drug, device, or biological product, when the jurisdiction is unclear or in dispute.
In an effort to improve the transparency of the jurisdiction process, capsular descriptions of selected jurisdictional decisions are provided below. In determining whether web-publication of a prior jurisdictional determination is appropriate for a particular product, FDA will take into account the extent to which the product can be suitably described, the extent to which the existence and description of the product or similarly described products has been made public, and related factors. In cases where it is not possible to adequately describe the subject of a jurisdictional decision and still protect trade secret and confidential commercial information, capsular descriptions of prior decisions will not be available.
It should be noted that these capsular descriptions describe prior FDA RFD decisions only and are not policy statements. The descriptions are intentionally general to ensure the protection of trade secret and confidential commercial information. Jurisdictional determinations are often influenced by subtle distinctions in a product’s composition, mode(s) of action, intended use and related factors, which are not fully reflected in the capsular descriptions. It is possible that a product that fits within one of the general capsular descriptions provided below might actually receive a different jurisdictional assignment, based on the consideration of factors not reflected in the brief capsular description provided.
Products Assigned to CBER[2]
A. Biological Products
- Interleukin for treatment of HIV and cancer*
- Hemostasis-factor based hemostatic agent
- Protein to maintain normal intestinal microflora*
- Synthetic protein for treatment of anemia*
- Plasmid vectored gene silencing to treat hepatitis
- Autologous cultured chondrocytes for cartilage repair
- Recombinant human protein to treat infection*
- Enzyme replacement therapy for Fabry disease*
- Immune globulin treatment for autoimmune skin disease
- Recombinant protein to treat bone diseases*
- Cancer vaccine and antibody for treatment of melanoma
- Antigenic modification of autologous blood for allergy treatment
B. Devices
- Device to process autologous cells for wound treatment
- Device to facilitate autograft transplantation
- Device to concentrate a therapeutic protein from autologous blood
- Device to prepare autologous fibrin sealant
- In vitro test kit to identify and enumerate CD34+ cells
- Device to determine concentration of CD34+ cells in peripheral blood and apheresis products
- In vitro urine test to aid in clinical diagnosis of HIV infection
- Immunodiagnostic assay for HIV (for individual patient use)
- Branched DNA technology-based quantification assay for HIV (for patient management)
- Device to inactivate pathogens in blood
- Device to modify blood cells
C. Drugs
- Sodium citrate solution to prevent coagulation during blood collection and storage
- Citrate-dextrose solution to prevent coagulation during extracorporeal blood processing
- Contrast agent-drug combination for tracking cells in cell therapy studies
D. Tissues
- Fascia lata particles for surgical use
E. Combination Products with Biological Product Primary Mode
of Action
- Biological product with implantable delivery device*
- Cellular transplant for diabetes treatment
- Biological hemostatic agent with reconstitution and delivery devices
- Fibrin sealant and delivery catheter
- Interferon and injector for treatment of hepatitis C*
- Injectable protein with delivery device for orthopedic use*
- Drug/biologic embolization agent
- Autologous cellular product and delivery device
- Radiolabeled antibody with detector device*
- Autologous cellular therapy and delivery device to treat cardiovascular disease
- Autologous cells and scaffold for orthopedic use
- Blood-derived protein and delivery device/dressing for wound treatment
- Menstrual tampon with bacteria to restore/maintain natural vaginal flora
- Autologous cells and scaffold for organ replacement
- Pegylated interferon and ribavirin to treat chronic hepatitis C*
- Interferon and drug to treat chronic hepatitis C*
- Blood-derived hemostatic agent and applicator
- Device and biologic to separate stem cells for reinfusion after chemotherapy
- Tumor-derived antigens for diagnostic use
- Recombinant growth factor and delivery vehicle*
- Monoclonal antibodies and magnetic microspheres to remove tumor cells from bone marrow
- Cultured bone marrow cells and bone void filler with handling agent for bone repair
- Autologous blood, light source, and photosensitizing agent for immunotherapy
- Gene therapy and drug for treatment of malignant glioma
- Autologous chondrocytes and scaffold for repair of cartilage defects
- Autologous mesenchymal cells and scaffold for diaphragm repair
Products Assigned to CDER
A. Drugs
- Ultrasound contrast agent
- Dye mouthrinse to examine oral tissue
- Orally administered drug for ultrasound imaging
- Drug used to determine plasma volume
- Inhaled chemoirritant to elicit cough reflex
- Hormone for the treatment of gastrointestinal disease
- Vital dye for ophthalmic use
- Aerosolized polysaccharide for pulmonary disorder
- Diagnostic drug administered to the bladder
- Drug for in vitro treatment of sperm
- Synthetic protein to treat HIV
- Solution used in continuous renal replacement therapy procedures
- Vitreous liquefaction agent
- Oxygen-carrying liquid drug to treat pulmonary conditions
- Antibiotic cream to treat nasal infections
- Agent to decontaminate chemical and biological warfare agents
- Extended-release synthetic compound for orthopedic use
- Isotope-based drug combination to diagnose digestive disease
- Topical agent for wound healing
- Recombinant hormone for the treatment of obesity
- Synthetic protein to treat chemotherapy side effect
- Hydroxyapatite-based dentifrice
- Solution for use in cardioplegia and preservation of the heart during cardiac surgery
- Enzyme to degrade viscoelastic agent during cataract surgery
- Synthetic immunomodulator for neurological use
- Drug used in therapeutic ultrasound procedures
- Polysaccharide for prevention/treatment of bacterial overgrowth
- Heat-activated chemotherapy drug
B. Biological Products
- Botulinum toxin for treatment of neuromuscular disorders
- Recombinant protein for dental use
- Monoclonal antibodies for treatment of blood disorder
C. Combination Products with Drug Primary Mode of Action
- Cytotoxic agent and biological product for targeted cancer treatment
- Gynecologic drug and delivery device
- Photosensitizing drug and light source for cancer treatment
- Drug and transdermal iontophoretic delivery system
- Fluoride-containing dental device for anticaries treatment
- Fluoride varnish for anticaries treatment
- Drug with injector to treat erectile dysfunction
- Drug with injector to treat anaphylactic reactions
- Drug with implantable delivery device
- Antiseptic skin preparation swabs
- Peritoneal dialysis solution and administration set
- Drug and delivery device for diagnosis of coronary artery disease
- Drug and delivery system for cancer treatment
- Drug and radiation emitting device to treat cancer
- Drug and delivery system for use with vein grafts
- Antimicrobial barrier
- Spermicidal gel with delivery device
- Antibiotic with biodegradable delivery device
- Drug reconstitution and delivery system
- Contrast agent and saline flush syringes
- Chemoablation drug and delivery device
- Cytotoxic agent and enzyme for cancer treatment
- Drug and drainage device for glaucoma treatment
- Drug and delivery system for localized bladder treatment
- Drug and device for ex vivo photodynamic cancer treatment
- Hormone to induce expression of breast fluids and sample collection device
- Enzymatic debriding agent/dressing for wound management
- Insulin and inhaler to treat diabetes
- Synthetic drug with controlled-delivery device for ophthalmic use
- Chemical agent and delivery system for gallstone dissolution
- Chlorhexidine gluconate swabs
- Radiolabeled contrast agent, production device and administration set
- Aerosolized radiolabeled contrast agent and production device
- Radiopharmaceutical and carrier for orthopedic use
- Drug and delivery system for internal tissue
- Photopheresis system and drug to treat skin cancer
- Drug, antibody and enzyme for cancer treatment
- PET drug and probe for tumor localization
- Topical drug and light source to treat skin cancer
- Patient-controlled transdermal system for pain management
- Drug and light source for dental use
- Drug and collagen combination for pain relief after lumbar surgery
- Aerosolized sodium chloride for halotherapy
- Prefilled insulin cartridges for use with a dedicated infusion pump
- Drug-eluting device to prevent restenosis of vascular grafts
- Condom with drug-containing gel to help maintain erection
- Cytotoxic agent-monoclonal antibody conjugate for cancer treatment
- Cartridges with prefilled syringes for use in specified reusable autoinjector
D. Combination Products with Biological Product Primary Mode of Action
- Cytotoxic monoclonal antibodies with device to remove excess antibodies
from patient
- Bone morphogenetic proteins and collagenous matrices for bone regeneration
Products Assigned to CDRH
A. Devices
- Agent used to prepare skin for adhesion of bandages
- Gel used as barrier to prevent surgical adhesions
- Hyaluronic acid viscosupplement for treatment of arthritis pain
- Absorbable barrier to prevent surgical adhesions
- Polysaccharide intended to act as protective barrier
- Radiation-containing glass beads for cancer treatment
- Device to hyperpolarize gas for use during magnetic resonance imaging
- Extracorporeal lipid removal system
- Physical barrier for dental use
- Oral wound dressing providing physical barrier
- Device to provide controlled hypoxia
- Needle-free injector for administration of a biological product
- Needle-free injector for administration of a drug
- Processed animal connective tissue for use in orthopedic surgery
- LAL-based in vitro test to aid in the diagnosis of fungal infections
- Device for disinfection of harvested bone
- Collagen/oxidized regenerated cellulose wound dressing
- Intraperitoneal drug delivery system
- Device that controls delivery of medication from implanted delivery system
- Human allograft demineralized bone matrix with additives to make putty or paste
(http://www.fda.gov/oc/combination/bone.html)
- Animal collagen bone void filler
- Medical maggots for wound treatment
- Solution for rinsing preserved organs prior to reimplantation
- Device to produce sterile water for injection
- Laser-activated surgical tissue welding tube
- Vitreous visualization agent
- Ozone production/delivery device for dental use
- Device that produces oxygenated water for topical oxygen therapy
- Device for pulsatile delivery of therapeutic solutions
- Kit for intestinal permeability testing
- Peak flow meter accessory for metered dose inhalers
- Bone and collagen allograft for bone grafting
- Device to monitor use of metered dose inhalers
- In vitro diagnostic test for hepatitis (for patient management)
- Immunodiagnostic assay for hepatitis (for individual patient use)
- Branched DNA technology-based quantification assay for Hepatitis C (for patient management)
- Branched DNA technology-based quantification assay for Hepatitis B (for patient management)
- Injectable polymer for urological use
- Sterile water for inhalation therapy
- Sterile water with saline for inhalation therapy
- Dressing that binds enzymes from wounds
- Adjunct to a PAP machine to treat breathing disorder
- Wound cleansing/debriding product
- Device that provides humidified hyperbaric oxygen for wound management
- Device for mixing and delivery of fibrin sealants
- Dual syringe applicator for delivery of fibrin sealants
- Reusable autoinjector for use with specified prefilled syringe cartridges
- Animal tissue-derived scaffold for ligament replacement
- Surfactant-based lubricant to act as adhesion barrier in pelvic and abdominal surgery
- Heating/drug delivery device for cancer treatment
- Device and inhaled gas mixture to measure cardiopulmonary function
- Topical paste for wound covering
- Accessories to blood/fluid warming device
- Polymeric sealant to seal air leaks in the lung
- Computer-based system to help monitor and manage Parkinson’s Disease
- More than minimally manipulated structural human tissue for use in vascular procedures
http://www.fda.gov/oc/combination/manipulation.html
- Device with tracer for evaluation of lung function
B. Combination Products with Device Primary Mode of Action
- Breath collection/analysis devices and drug for H. pylori diagnosis
- Laser and photosensitizing agent for antimicrobial use
- Dialysate with drug component
- Heparin-coated cardiovascular stent
- Drug-eluting cardiovascular stent
http://www.fda.gov/oc/combination/stents.html
- Radiolabeled drug-eluting cardiovascular stent
- Vascular graft with antibiotic
- Dental floss with fluoride
- Dental floss with antimicrobial agent
- Dental filling material with antimicrobial agent
- Dental sealant with antimicrobial agent
- Dental cement with antimicrobial agent
- Periodontal barrier with antibiotic
- Adhesive bandage with antibiotic
- Physical/chemical embolization product
- Cardiovascular stent and injectable drug
- Orthopedic prosthesis coated with growth factor
- Coronary stent coated with biological product
- Dental prophylaxis paste with fluoride and antimicrobial agent
http://www.fda.gov/oc/combination/dental.html
- Dental implant coated with autologous cells
- Dental implant and synthetic peptide used to promote its integration
- Wound dressing impregnated with drug ointment
- Occlusive wound dressing with biologic component
- Catheter lock flush solution with antimicrobial and anticoagulant agents
http://www.fda.gov/oc/combination/catheter.html
- Dental wax with anesthetic for discomfort associated with orthodontic procedures
- Dental restorative material with fluoride
- Breath collection/analysis devices and drug for diagnosis of lactose maldigestion
- Breath collection/analysis devices and drug for diagnosis of gastric emptying disorders
- Breath collection/analysis devices and drug to monitor enzyme activity
- Breath test kit and drug for use during pharmacological research
- Breath collection/analysis devices and drug for diagnosis of intestinal bacterial overgrowth
- Breath test and drug for assessment of small intestinal function
- Blood test and drug for detection of H. pylori in the stomach
- Embolization device coated with a radiopharmaceutical drug
- Root canal cleanser with antimicrobial agent
- Device with enzyme mimic for orthopedic use
- Bone void filler with antibiotic
- Menstrual tampon with drug to neutralize pH within the tampon
- Fluorescent imaging system for use during cardiac surgery
- Tubing with drug to reduce discomfort during placement
- Device and lithium chloride indicator dilution to monitor cardiac output
- Device for delivery and filtration of chemotherapeutic agents to organs
- Device and filtration system to administer chemotherapy to limbs
- Polymer-astringent granules for wound/laceration management
- Laser and photosensitizing agent for dental use
- Non-occlusive wound dressing with drug
- Wound dressing with analgesic
- Wound dressing with antimicrobial agent
- Bone void filler with blood component to act as matrix and enhance handling properties
- Vascular graft with drug-eluting mesh to maintain graft patency
- Breath test kit and drug to measure liver function
- Scaffold/matrix for wound treatment
- Device and soluble intravenous gases to evaluate pulmonary function
- Chemiluminescent light and dye for oral lesion marking
- Collagen-thrombin hemostatic agent
- Gelatin granules-thrombin hemostatic agent
- Breath test kit and drug for diagnosis of insulin resistance
- Cryotherapy device and salicylic acid for wart removal
- Central venous catheter with antimicrobial coating
- Therapeutic ultrasound device and gas microspheres for thrombolytic therapy
- Surgical mesh with anesthetic coating
- Scented respiratory device
Footnotes:
[1]A combination product is assigned to an Agency center that will have primary jurisdiction for its premarket review and regulation. Under section 503(g) of the Act, the assignment of a “lead center” is based upon a determination of the “primary mode of action” (PMOA) of the combination product. For example, if the PMOA of a combination product is that of a biological product, then the combination product would be assigned to the Agency component responsible for premarket review of that biological product. Depending upon the type of combination product, approval, clearance or licensure may be obtained through submission of a single marketing application, or through separate marketing applications for the individual constituent parts of the combination product. The listings below identify the lead Center for each combination product based on the product’s PMOA, but in some cases, a marketing application to another Center may also have been requested.
[2] *On June 30, 2003, FDA transferred responsibility for the regulation of certain therapeutic biological products from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER). Accordingly, the persons charged with premarket review of these products are now located within CDER, not CBER, and certain products transferred at the same time FDA transferred this responsibility. It should be noted that some of the therapeutic biological products identified as being assigned to CBER at the time the RFD determination was made are now assigned to CDER. More information about the transfer is available at http://www.fda.gov/oc/combination/transfer.html.
