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Accelerating Product Development

Accelerating Product Development. You have received your 510(k) clearance or PMA approval, and it is off to the races, right?. Wrong. It is one step of the process, and you have many more to go. Establishment Registration Device Listing Quality System Regulation (21CFR Part 820)

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Accelerating Product Development

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  1. Accelerating Product Development

  2. You have received your 510(k) clearance or PMA approval, and it is off to the races, right? • Wrong. It is one step of the process, and you have many more to go.

  3. Establishment Registration • Device Listing • Quality System Regulation (21CFR Part 820) • Medical Device Reporting • Recalls, Corrections and Removals • Exports • Imports • Medical Device Tracking • Medical Device Postmarket Transformation Initiative • Medical Product Safety Network (MedSun) • Unique Device Identification • Safety News, Issues, Notifications and Alerts • Postapproval Studies (“Condition of Approval” studies) • Postmarket Surveillance

  4. This presentation covers: • Establishment Registration • Device Listing • Exports • Imports • Medical Device Tracking • Postapproval Studies • Postmarket Surveillance

  5. “Submit registration and /or listing information within 30 days of an establishment beginning an activity or putting a device into commercial distribution.” • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053181.htm • 21CFR807 - Applies to: • Intended for human use • Whether or not the device enters into interstate commerce • Registration and Listing are NOT substitutes for product approval/clearance. • Must still have 510(k) clearance or PMA approval before commercializing your product.

  6. Annual process (Oct 1 through Dec 31) • Interim Changes • Address • Owner/Operator • Official Correspondent • Types of registration • Manufacturer (domestic and foreign) • Specifications developer • Contract manufacturer • Initial importer • Contract sterilizer • Domestic distributors • Many others

  7. Annual process (Oct 1 through Dec 31) • Interim Changes • Additions • Deletions • Changes, i.e. manufacturing site • Information Required: • Classification name & Device Class • Regulation Number, Product Code & Medical Specialty • All proprietary names under which your device is marketed, including private labels • 510(k) or PMA number • Details of what is done to device at your establishment • Registration Name & Number • Owner/Operator Name & Number This becomes public information.

  8. Devices that are legally marketed in the US may be exported without prior FDA notification or approval • Different Types of Export Certificates • Certificate of Exportability under section 801(e)(1)* • Class I or II devices not approved for marketing in US • May be legally exported without a certificate • Certificate of Exportability under section 802* • Class III devices not approved for marketing in the US • May be legally exported without a certificate • Non-clinical research use only* • Used in lab research animals • IVDs not for use in humans / not represented as an effective IVD • Certificates to Foreign Governments • Export Permits* • *See FDA website for full details • http://www.fda.gov/downloads/Training/CDRHLearn/UCM234354.pdf

  9. Certificates to Foreign Governments (CFGs) • Requested by foreign governments • Issued by FDA • State that device: • Is legally marketed in the US • Is compliant with the FD&C act • Meets GMPs • Expire after two years • Won’t be issued if you have open recalls • CFGs may not be used for domestic advertising

  10. All medical devices that are imported into the U.S. must meet Bureau of Customs and Border Protection (CBP) requirements in addition to FDA requirements. • Product that does not meet FDA requirements may be detained upon entry. • Foreign manufacturers must meet applicable US medical device regulations • Registration of establishment, listing of devices, manufacturing in accordance with the quality system regulation, medical device reporting of adverse events, and Premarket Notification 510(k) or Premarket Approval, if applicable. • In addition, the foreign manufacturers must designate a US Agent  • Initial importers must also register with the FDA. • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ImportingandExportingDevices/ucm050126.htm#process

  11. When required by the Agency • 21CFR821 • May be applied to Class II or III devices: • whose failure would be reasonably likely to have serious, adverse health consequences • which is intended to be implanted in the human body for more than one year • are life-sustaining or life-supporting devices used outside of a device user facility • Manufacturers must establish written SOP which includes a method for tracking the device throughout distribution and a quality assurance program including audit procedures. • Final distributors of these devices will be required to provide manufacturers with patient information.  • Required for projected useful life of the device • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/MedicalDeviceTracking/default.htm

  12. Two types of postmarket study/surveillance activities: • Post-approval studies required at the time of product approval • Postmarket surveillance studies may be required under section 522 of the FD&C act • CDRH automated tracking system • Publicly available webpage showing study status • http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm

  13. Post Approval Studies • “Condition of Approval” studies • Designated at the time of approval for: • a premarket approval (PMA) • a humanitarian device exemption (HDE) • product development protocol (PDP) application • To help assure continued safety and effectiveness (or continued probable benefit, in the case of an HDE) •  Encompasses design, tracking, oversight, and review responsibilities • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/PostApprovaStudies/default.htm

  14. Postmarket surveillance studies • Section 522 of the FD&C Act gives FDA the authority to require a manufacturer to conduct postmarket surveillance of a class II or class III device that meets any of the following criteria: • its failure would be reasonably likely to have serious adverse health consequences; • it is expected to have significant use in pediatric populations; • it is intended to be implanted in the body for more than one year; or • it is intended to be a life-sustaining or life-supporting device used outside a device user facility • Encompasses design, tracking, oversight, and review responsibilities • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ • PostmarketRequirements/PostmarketSurveillance/default.htm

  15. Next Up: • Quality System Regulation • Questions?

  16. Accelerating Product Development About Pearl Pathways

  17. Device Companies • Pharmaceuticals • Biotech • Diagnostics • Combination Products • CROs/CMOs • Labs • Tech Transfer/Academics • Research Sponsors • Research Sites • VC’s Who do we serve? From start ups to multinationals

  18. What shapes our behaviors each day? • Driving improved value and efficiency in product development • Accelerating regulatory pathways • Setting the bar on quality compliance standards • Protecting human subjects • Enabling smart, effective and high quality product development • How are we different? • Partnership and service mindset • Midwest location and values • Founders with extensive sponsor and regulatory service backgrounds • Thoughtful, proactive business model created to solve problems in drug and device development • Woman owned WBENC certified • Efficient. Ethical. Experienced. Pearl Pathways Vision and Mission

  19. Pearl Pathways

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