1. Device Updates in FDASIA MDUFA III RA SAIC – 9 th April 2013 Karen Jaffe, MS, MBA, RAC kjaffe1964@gmail.comkjaffe1964@gmail.com or kjaffe@usc.edukjaffe@usc.edu

2. FDASIA Some simple math….. FDASIA = PDUFA V + MDUFA III PLUS two new “UFA’s” GDUFA and BsUFA

3. Focus on MDUFA III MDUFA I was initially enacted in 2002 Reauthorized in 2007 (MDUFA II) And again in 2012 as a part of FDASIA Like PDUFA, intended to fund the review process The Medical Device Tax is NOT part of FDASIA / MDUFA. It is/was a part of Obamacare

4. Focus of Updates in Reauthorization Fees Performance Goals & Review times Global Supply chain New Guidances Establishment and Registration Listing

5. Updates to Fees MDUFA fees apply to ANY establishment – not just manufacturers and specification developers PMA fees increase to $248,000 in FY 2013 PMA fees will increase to $268,443 by FY 2017 510k fees are 2% of PMA fees Establishment fees are $2,575 in FY2013 Establishment fees will increase to $3,872 in FY2017 MDUFA fees can be waived if “it is in the interest of public health”.

6. MDUFA III Fees (cont.) $595 Million over 5 years Adjusted annually for actual inflation with 4% cap in any year Addition of 240 FTEs o 32 in FY12 from remaining MDUFA II funding o 208 FTEs under MDUFA III

7. Review Times and Performance MDUFA II had tiered performance goals for each submission type: 510kPMA Tier 1 90% of initial submissions in 90 days 97%60% of initial submissions in 180 days 34% Tier 2 98% in 150 days 99.9%90% in 295 days 67% Completion defined as: SE / NSE declaration or 510k not required Approval order, (not) approvable letter, major deficiency, or denial.

8. MDUFA III Performance Goals No tiers in MDUFA III FY 510k (90 day clock) Calendar days PMA (No panel, 180 day clock) PMA (Panel, 320 day clock) Calendar days 2013 91%13570%50%395 2014 93%,13580%70%395 2015 95%13080% 390 2016 95%13090%80%390 2017 95%12490% 385

9. MDUFA III Additional Performance Measures Quarterly and annual reporting o Progress towards performance goals o Additional information Average number of review cycles NSE rates Withdrawal rates IDE information All information Annual performance report to Congress Independent evaluation of FDA’s management of review process o Scope o Timeline *Source: MDMA

10. Additional Interactions – 510k Acceptance Review: The FDA will conduct a preliminary Acceptance Review within 15 calendar days of receiving a 510(k) application or notify applicants of any Refuse to Accept (RTA) decisions. Substantive Interaction: An applicant will be notified within 60 calendar days of Substantive Interaction— meaning either that reviewers have determined Substantial Equivalency for their device, issued a request for additional information (AI) or will proceed with an Interactive Review to resolve any issues. Limited Extensions: Only two rounds of review are planned for 510(k) submissions starting in the 2013 fiscal year: the original submission review and any request for additional information (AI). The agency will grant only one 180- day extension in the event of an AI request.

11. Additional Interactions - PMA Refuse to Accept: Within 15 calendar days, communicate with the applicant regarding whether its application has been accepted for filing review. Refuse to File: Within 45 days of FDA’s receipt of the application (original) or 90 days for supplements, communicate with the applicant regarding the application’s filing status, including providing specific reasons for any refusal to file. Substantive Interaction: Within 90 calendar days of the filing date of the application, communicate with the applicant through a “Substantive Interaction”2 for 65% of submissions received in fiscal year 2013, 75% in 2014, 85% in 2015, and 95% in 2016 – 2017.

12. HDE Profit Limitations Evolution over time 1990 SMDA: NO profit eligibility 2007 FDAA: profit eligibility for newly approved HDE devices labeled for pediatrics 2012 FDASIA: expansion of profit eligibility beyond pediatrics and to previously approved HDEs Determined by Annual Distribution Number (ADN) Number of devices that can be sold per year at a profit No User Fee 75 Day Review time

13. HDE Profit Eligibility FDAAA (2007) If the device is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs. FDASIA (2012) If the device is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs; or does not occur in pediatric patients; or occurs in pediatric patients in such numbers that the development of the device for such patients is impossible, highly impracticable, or unsafe.

14. HDE Profit Eligibility FDAAA (2007) Applies only to newly approved HDEs ADN capped at 3,999 ADN = product of: # of devices reasonably necessary to treat, diagnose, or cure an individual # of individuals affected by the disease or condition the HUD is intended to treat, diagnose, or cure and that are likely to use the device FDASIA (2012) May apply to previously approved HDEs ADN not capped ADN = product of: # of devices reasonably necessary to treat, diagnose, or cure an individual 4,000

15. Guidance Development - Final Refuse to Accept (RTA) Policy for 510(k) Submissions Acceptance and Filing Review for Premarket Approval Applications Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies In Vitro Companion Diagnostic Devices Design Considerations for Pivotal Clinical Investigations for Medical Devices De Novo Classification Process (Evaluation of Automatic Class III Designation) The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications CDRH Appeals Processes Medical Device Classification Product Codes The Pre-Submission Program and Meetings with FDA Staff Mobile Medical Applications eCopy Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents

16. Guidance Development - Draft Distinguishing and Reporting Medical Device Recalls from Product Enhancements Types of Communication During the Review of Medical Device Submissions FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations eCopy Appropriate Use of Voluntary Consensus Standards in Premarket Submissions

17. Establishment and Registration Listing Changes ALL finished medical device contract manufacturers and sterilizers – GLOBALLY – must register with FDA Finished device contract manufacturers and sterilizers now require their own US Agent Foreign establishments must identify all US importers of their device(s) Your 510k or PMA number will be required when registering with FDA Single point of contact as well as brand names/proprietary names required in FURLS Establishments dedicated to complaint management need to specify their establishment type to Complaint File Establishment.

18. References Hamburg FY2012 MDUFA Performance Report: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports /UserFeeReports/PerformanceReports/MDUFMA/UCM342644.pdf FDA Guidances: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandG uidance/GuidanceDocu ments/UCM313794.pdf http://www.fda.gov/MedicalDevices/DeviceReg ulationandGuidance/GuidanceDocuments/ucm 089735.htm