regulatory pathway for platform technologies quynh hoang neurotherapeutic and neurodiagnostic...
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Regulatory Pathway for Platform Technologies
Quynh HoangNeurotherapeutic and Neurodiagnostic Devices BranchDivision of Ophthalmic, Neurological and Ear, Nose and
Throat DevicesOffice of Device Evaluation
Center for Devices and Radiological Health
ASENT February 24, 2011
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Disclaimer
This presentation reflects the views of the author and should not be construed to represent FDA’s
views or policies.
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Overview
• Regulatory definitions: drug, device, biological product, combination product
• Medical Device Platform Technology Examples• OCP and Lead Center• Medical Device Classifications and
Corresponding Applications• Medical Device Submissions for Platform
Technology Examples• Recent Development in CDRH
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Center for Tobacco Products
(CTP)
Center forBiologics
Evaluation &Research(CBER)
Center for Devices &
Radiological Health(CDRH)
Center for DrugEvaluation and
Research(CDER)
National Center for Toxicology
Research(NCTR)
Center for VeterinaryMedicine
(CVM)
Center for Food Safety & Applied Nutrition(CFSAN)
FDA
OCP
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Drug Definition
(A) articles recognized in the US Pharmacopoeia, Homeopathic Pharmacopoeia, or National Formulary; or
(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or
(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals.
21 USC 201(g)
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Device Definition
Instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is -
(1) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, or
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals,
and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
21 USC 201(h)
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Biological Product Definition– Virus– Therapeutic Serum– Toxin or Antitoxin – Vaccine– Blood, Blood Component or Derivative – Allergenic Product– Protein (except any chemically synthesized
polypeptide) – Analogous Product (e.g., human tissues)– Arsphenamine or its derivativesapplicable to the prevention, treatment, or cure of diseases or
injuries of man42 USC 262 (as amended 2010)
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Combination Product Definition
Combination of– Biological Product & Device– Biological Product & Drug– Device & Drug – Biological Product & Device & Drug– NOT of drug&drug, device&device or
biologic&biologicCombination from being:
– Physically or chemically combined– Co-packaged in a kit– Separate, cross-labeled products
21 CFR 3.2(e)
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Medical Device Platform Technology Examples
• New indication for a marketed device
• New component for a marketed device to support new indication
• Combining a marketed device with a marketed drug and/or biological product
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Medical Device Platform Technology Examples
• New indication for a marketed device
• New component for a marketed device to support new indication
• Combining a marketed device with a marketed drug and/or biological product
Device
CombinationProduct !
Device
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Office of Combination Product (OCP)
OCP determines lead Center
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OCP’s algorithm
1. Primary mode of action2. If unable to determine most important
therapeutic action with reasonable certainty, consider:
– Consistency: is there an agency component that regulates other combination products presenting similar questions of S & E with regard to combination product as a whole?
– Safety and Effectiveness: which agency component has the most expertise related to most significant S&E questions presented by combination product?
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Medical Device Platform Technology Examples
• New indication for a marketed device
• New component for a marketed device to support new indication
• Combining a marketed device with a marketed drug and/or biological product
Device
CDRH-Lead
Device
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Device Regulation is Risk-based
Medical Device Classes:
Class I General ControlsMost exempt from premarket submission
Class II General ControlsSpecial ControlsPremarket Notification [510(k)]
Class III Premarket Approval
Premarket Approval Application [PMA]
Additional Classification:De Novo
Device "types" that have never been marketed in the U.S., but whose safety profile and technology are now reasonably well understood
Humanitarian Device Exemption (HDE)
Devices for orphan diseases intended to benefit patients in diagnosis and/or treatment of disease or condition affecting or manifested in fewer than 4,000 patients per year in the US.
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Investigational Device Exemptions (IDE) application
An FDA approved IDE allows a significant risk investigational device to be used in a clinical study in the U.S. in order to collect safety and effectiveness data
21 CFR 812
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Medical Device Platform Technology Examples
• New indication for a marketed device
• New component for a marketed device to support new indication
• Combining a marketed device with a marketed drug and/or biological product
What was the marketing pathway for the platform technology?
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Platform Technology was 510(k) “cleared” or De Novo “classified”
• Change to Indication: Does the change to the indication alter the intended therapeutic/diagnostic/etc. effect (or impact safety or effectiveness)?
• Change to Technology: Does the change raise new types of safety or effectiveness questions?
No to both 510(k)Yes to either De Novo, PMA, or HUD/HDE
AND supporting clinical (IDE) data for a significant risk device
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Platform Technology was PMA “approved”
• Original PMA• Panel-Track PMA Supplement, or• PMA Supplement
(with IDE data to support new indication or claim)
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Platform Technology was HDE “approved”
Request a Humanitarian Use Device (HUD) Designation from the Office of Orphan Products Development for the new device.
a. If HUD is granted, HDE (with clinical to support new indication).
b. If HUD is not granted, 510(k) or PMA.
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Marketing Applications
• 510(k) – substantial equivalence to a predicate
• De Novo– After a not-substantially-equivalent 510(k)
determination– Low risk, Available data and Special controls
• PMA – reasonable assurance of safety and reasonable assurance of effectiveness
• HDE – reasonable assurance of safety and probable benefit
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Some Recent Developments in CDRH
• CDRH Preliminary Internal Evaluations of the 510(k) review process
• CDRH Innovation Pathway• Streamline the De Novo process
www.fda.gov (search highlighted terms)
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FDA Contacts
• OCP: [email protected] or 301-796-8930 • Orphans Product: 301-796-8660• Medical Device Pre-market Process-Programs
Operations Staff: [email protected] or 301-796-6560
• Neuro Device Pre-market Questions: [email protected] or 301-796-6610
CDRH Information Resources: search term “CDRH Learn” or “Device Advice” from Google or on www.fda.gov
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Thank You!