Presentation on theme: "Regulatory Pathway for Platform Technologies"— Presentation transcript:
1 Regulatory Pathway for Platform Technologies Quynh HoangNeurotherapeutic and Neurodiagnostic Devices BranchDivision of Ophthalmic, Neurological and Ear, Nose and Throat DevicesOffice of Device EvaluationCenter for Devices and Radiological HealthASENT February 24, 2011
2 DisclaimerThis presentation reflects the views of the author and should not be construed to represent FDA’s views or policies.
3 OverviewRegulatory definitions: drug, device, biological product, combination productMedical Device Platform Technology ExamplesOCP and Lead CenterMedical Device Classifications and Corresponding ApplicationsMedical Device Submissions for Platform Technology ExamplesRecent Development in CDRH
5 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)
6 Device DefinitionInstrument, 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)
7 Biological Product Definition VirusTherapeutic SerumToxin or AntitoxinVaccineBlood, Blood Component or DerivativeAllergenic ProductProtein (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)
8 Combination Product Definition Combination ofBiological Product & DeviceBiological Product & DrugDevice & DrugBiological Product & Device & DrugNOT of drug&drug, device&device or biologic&biologicCombination from being:Physically or chemically combinedCo-packaged in a kitSeparate, cross-labeled products21 CFR 3.2(e)
9 Medical Device Platform Technology Examples New indication for a marketed deviceNew component for a marketed device to support new indicationCombining a marketed device with a marketed drug and/or biological product
10 Medical Device Platform Technology Examples New indication for a marketed deviceNew component for a marketed device to support new indicationCombining a marketed device with a marketed drug and/or biological productDeviceDeviceCombinationProduct !
11 Office of Combination Product (OCP) OCP determines lead Center
12 OCP’s algorithm Primary mode of action 2. 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?
13 Medical Device Platform Technology Examples New indication for a marketed deviceNew component for a marketed device to support new indicationCombining a marketed device with a marketed drug and/or biological productDeviceDeviceCDRH-Lead
14 Device Regulation is Risk-based Medical Device Classes:Class IGeneral ControlsMost exempt from premarket submissionClass IISpecial ControlsPremarket Notification [510(k)]Class IIIPremarketApprovalPremarket Approval Application [PMA]Additional Classification:De NovoDevice "types" that have never been marketed in the U.S., but whose safety profile and technology are now reasonably well understoodHumanitarian 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.
15 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 data21 CFR 812
16 Medical Device Platform Technology Examples New indication for a marketed deviceNew component for a marketed device to support new indicationCombining a marketed device with a marketed drug and/or biological productWhat was the marketing pathway for the platform technology?
17 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/HDEAND supporting clinical (IDE) data for a significant risk device
18 Platform Technology was PMA “approved” Original PMAPanel-Track PMA Supplement, orPMA Supplement(with IDE data to support new indication or claim)
19 Platform Technology was HDE “approved” Request a Humanitarian Use Device (HUD) Designation from the Office of Orphan Products Development for the new device.If HUD is granted, HDE (with clinical to support new indication).If HUD is not granted, 510(k) or PMA.
20 Marketing Applications 510(k) – substantial equivalence to a predicateDe NovoAfter a not-substantially-equivalent 510(k) determinationLow risk, Available data and Special controlsPMA – reasonable assurance of safety and reasonable assurance of effectivenessHDE – reasonable assurance of safety and probable benefit
21 Some Recent Developments in CDRH CDRH Preliminary Internal Evaluations of the 510(k) review processCDRH Innovation PathwayStreamline the De Novo process(search highlighted terms)
22 FDA Contacts OCP: firstname.lastname@example.org or 301-796-8930 Orphans Product:Medical Device Pre-market Process-Programs Operations Staff: orNeuro Device Pre-market Questions: orCDRH Information Resources: search term “CDRH Learn” or “Device Advice” from Google or on