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Regulatory Boot Camp: Bringing a Product to Market and Avoiding Regulatory Pitfalls MassMEDIC December 13, 2007 Mass Medical Society Waltham, MA Insert Picture Here Robert Yocher, M.H.Sc., RAC VP RA/CQC Genzyme Corp. Wide Variety of Devices Medical devices vary in terms of the risks that they present: Permanent implant or short term patient contact Circulating blood contacting or patient fluid contact Patient contacting or non-patient contacting Energy emitting or passive Diagnostic or Therapeutic Tool or treatment Risk Based Classification Provides Flexibility Class III devices: Most complex, highest risk Breakthrough technology or high risk (life sustaining,life supporting) Premarket review and approval required through a Premarket Approval Application (PMA) or Humanitarian Device Exemption (HDE) Submitter required to demonstrate reasonable assurance of safety and effectiveness Clinical trials necessary ($$$$$$!) Examples: High intensity focused ultrasound devices, drug eluting coronary stents, photodynamic therapy devices, deep brain stimulators Expect Two Submissions Investigational Device Exemption and PreMarket Approval Application Most stringent most lengthy of Device pathways (typically 1-3 yrs. or more) Contains sufficient “valid scientific evidence” that provides “reasonable assurance” that the device is safe and effective for its intended use or uses. Premarket Approval Options Expedited PMA Streamlined PMA Standard PMA Modular PMA An applicant can request Expedited Review for Standard or Modular PMAs Reality –doesn’t make much difference! Expedited PMA Review Geared toward devices that have a major public health impact Device that is intended to treat or diagnose life- threatening or irreversibly debilitating diseases or conditions; and Meets one of the following criteria: Expedited PMA Review Criteria Represents a breakthrough technology with a clear clinically meaningful advantage over existing technology;or… Has no approved alternative;or… Offers significant advantages over approved alternatives; or… Is in the best interest of patients. Expedited PMA Review Expedited review entitles the marketing application to review before other pending applications Streamlined PMA Process Designed for devices using well-known technologies with well known disease processes PMAs may qualify as Streamlined if: the device has a review guidance; or two or more previous PMAs have been approved for the same type of device; or the device has a study protocol jointly developed by the manufacturer and FDA Contact FDA to determine eligibility. Submit study protocol to FDA for review Use abbreviated Summary of Safety and Effectiveness by attaching Executive Summary to labeling Manufacturing inspection may be deferred if FDA completed a GMP inspection within past 2 yrs Final Review within 180 day cycle Standard and Modular PMAs Standard IDE submitted and approved Complete PMA submitted Modular PMA shell developed during IDE process IDE submitted and approved Modules are submitted to FDA as they are completed FDA reviews modules over time Both have the same content requirements Content of a PMA A PMA application must contain: General information (name and address of applicant, Table of Contents) Summary of Safety and Effectiveness Description of the device and its manufacturing process Reference to performance standards Environmental assessment Content of a PMA (continued) Non-Clinical studies Clinical Investigations Financial certification and/ or disclosure statements Labeling Literature review/bibliography other information requested by FDA Sample device, if requested PMA “FDA regulations provide 180 days to review the PMA and make a determination. In reality, the review time is normally longer. Before approving or denying a PMA, the appropriate FDA advisory committee may review the PMA at a public meeting and provide FDA with the committee's recommendation on whether FDA should approve the submission. After FDA notifies the applicant that the PMA has been approved or denied, a notice is published on the Internet (1) announcing the data on which the decision is based, and (2) providing interested persons an opportunity to petition FDA within 30 days for reconsideration of the decision.” http://www.fda.gov/cdrh/devadvice/pma/ accessed 12/10/07 Timeline & Milestones Filing review 45 days BIMO inspections 70-90 days Manufacturing Inspection 90 -120 days Day 100 meeting Prep for panel 2-4 weeks Panel hearing Labeling negotiations Final determination Post market responsibilities User Fees FY 2008 Device Review User Fees (U.S. Dollars) Type of ApplicationStandard Fee/Small Business Fee (<$100 million sales) Premarket Application (PMA, PDP, BLA, PMR) *NOTE: The fee is waived for the first premarket application from firms with gross receipts or sales <$30 million. $185,000/$46,250 PMA/BLA/PDP $185,000/$46,250 Premarket Report (PMR) - premarket approval application for a reprocessed device $185,000/$46,250 Efficacy Supplement (for BLA) $138,750/$34,688 Panel-track Supplement $ 27,750/$6,938 180-day Supplement $ 12,950/$3,237 Real-time Supplement $ 2,960/$1,480 30-Day Notice/135-Day PMA Supplement** $ $6,475/$1,619 Annual Fee for Periodic Reporting on a Class III Device** * PMA=Premarket Approval; PDP=Product Development Protocol; BLA=Biologics License Application; PMR=Premarket Report (for a reprocessed device) **New for FY08 Fees and Exemptions Exemptions and Waivers The following types of applications require no fee. Special PMA Supplements-Changes Being Affected Express PMA Supplements Humanitarian Device Exemption (HDE) BLA for a product licensed for further manufacturing use only. The following exemptions or waivers apply. Fee Exemptions and Waivers (No Fee for These) Category Exemption or Waiver First premarket application (PMA, PDP, BLA, or premarket report) from a small business with gross receipts or sales <$30 million . One-time waiver of the fee that would otherwise apply. Any application for a device intended solely for pediatric use. Exempt from any fee. If an applicant obtains an exemption under this provision, and later submits a supplement for adult use, that supplement is subject to the fee then in effect for an original premarket application. Any application from a State or Federal Government entity. Exempt from any fee unless the device is to be distributed commercially. PMA PROs CONs High regulatory bar means Expensive fewer competitors Time consuming Competitors cannot use your Restrictive Manufacturing data Restricted device Competitors must spend the Labeling, advertising & time and money promotion restrictions Liability protection? Suggestions Try to de novo classify to Class II (510k) Limit your claims Hire an experienced RA professional Hire experienced consultants Look for partners Resist changes by assessing risks Expect to take longer and be more expensive than you planned. Questions??
"Regulatory Boot Camp Bringing a "