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Regulatory Pathway for Platform Technologies

Regulatory Pathway for Platform Technologies. Quynh Hoang Neurotherapeutic and Neurodiagnostic Devices Branch Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health. ASENT February 24, 2011. Disclaimer.

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Regulatory Pathway for Platform Technologies

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  1. Regulatory Pathway for Platform Technologies Quynh Hoang Neurotherapeutic and Neurodiagnostic Devices Branch Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health ASENT February 24, 2011

  2. Disclaimer This presentation reflects the views of the author and should not be construed to represent FDA’s views or policies.

  3. 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

  4. OCP

  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 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 actionwithin or on the body of man or other animalsand which is not dependent upon being metabolized for the achievement of its primary intended purposes. • 21 USC 201(h)

  7. 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 derivatives applicable to the prevention, treatment, or cure of diseases or injuries of man 42 USC 262 (as amended 2010)

  8. 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&biologic • Combination from being: • Physically or chemically combined • Co-packaged in a kit • Separate, cross-labeled products 21 CFR 3.2(e)

  9. 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

  10. Medical Device Platform Technology Examples Device • 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 Combination Product !

  11. Office of Combination Product (OCP) OCP determineslead 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 Device • 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

  14. Device Regulation is Risk-based • Medical Device Classes: • Class I • General Controls • Most exempt from premarket submission • Class II • General Controls • Special Controls • Premarket 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.

  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 data 21 CFR 812

  16. 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?

  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/HDE AND supporting clinical (IDE) data for a significant risk device

  18. Platform Technology was PMA “approved” • Original PMA • Panel-Track PMA Supplement, or • PMA 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 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

  21. 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)

  22. FDA Contacts • OCP: combination@fda.gov or 301-796-8930 • Orphans Product: 301-796-8660 • Medical Device Pre-market Process-Programs Operations Staff:Robert.Gatling@fda.hhs.gov or 301-796-6560 • Neuro Device Pre-market Questions: Quynh.Hoang@fda.hhs.gov or 301-796-6610 CDRH Information Resources: search term “CDRH Learn” or “Device Advice” from Google or on www.fda.gov

  23. Thank You!

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