Fee Amendments IV - fda.gov

1 Medical Device User Fee Amendments IV independent assessment of Food and Drug Administration s Device Review process Management DELIVERABLE 17 AND DELIVERABLE 20: FINAL REPORT AND RECOMMENDATIONS CONTRACT NO. HHSF223201510027B ORDER NO. HHSF22318001 T h is documen t is confid ential and intende d sol ely for the cl ien t to w hom it is a ddressed. i TABLE OF CONTENTS EXECUTI VE 1 1. assessment BACKGROUND AND OBJECTI VES .. 4 2. METHODOLOGY .. 4 O verall Approa ch .. 4 Ev al ua ti on Fra mewor 5 Stra tegi c Fra 5 Data Coll ecti on and Analysis .. 6 CDRH Da ta Sys tems .. 7 Au di ts .. 7 T ra i ni n g Da ta .. 9 I n ter nal /Ex ter nal C o mmu nica tio ns ..10 C a s e S t u di es ..10 I n t er vi e ws.

2 10 S u rv 3. assessment CDR H O p er a ti ons ..11 Rec ommenda ti on 1a *: Continuous Proc ess Impr ovement (CPI ) ..11 Recommendation 1b*: Document Control Enhancements ..14 Rec ommenda ti on 8: Workl oa d Ma nagement Tool Revi Rec o mmenda ti on 11 : Sta ff Tur n ov er an d Tra nsi tio n Plans ..20 CDRH Staff Rec o mmenda ti ons 6 * an d 9 *: Enha nc emen ts o f For mal Trai nin g ..23 Recommendation 10: Promotion of Informal Traini Su b missio n Revi ew: Sub-Proc ess Ma na gement ..29 Rec ommenda ti on 3: Refus e To Acc ept (RTA) Proc ess I mpr ovement ..30 Rec o mmenda ti on 4 : Wi th dra wn Su b missions Analysis ..34 Rec o mmenda ti on 5 : Sp ons or Co mmunica ti o ns .. 37 Rec o mmenda ti on 7 : eCo py Guida nc e.

3 40 3. 4 Submission Revi ew: Quali ty Ma na gement ..42 Rec ommenda ti on 1c *: Revi ew Proc ess Quali ty Rec ommenda ti on 2: Decision-Making Consis tency ..44 4 . P ROP OSED NEXT STEPS ..52 5 . APP ENDI X ..54 Glossary ..54 Cha rac teris tics of FY20 15 FY2017 Receipt Cohort and MDUFA Audit T h is documen t is confid ential and intende d sol ely for the cl ien t to w hom it is a ddressed. ii List of Figures Fi gu re ES-1. Timeline of MDUFA III /IV inde penden t assessment o f medi cal de vi ce re vie w p ro cess .. 1 Fi gu re 2-1. Booz Allen s evalua tion fra 5 Fi gu re 2-2. Booz Allen s s tra tegi c fra 6 Fi gu re 2-3. Summa ry of da ta sources for the evaluation of FDA implementation projects.

4 6 Fi gu re 2-4. Gene ratio n of MD UFA and Wi th d rawn Audi t Coh o rts fro m FY2015 FY2017 Re ceipt 8 Fi gu re 2-5. Division breakdown of ODE and OIR respondents .. 10 Fi gu re 2-6. Role of surve y respondents .. 11 Fi gu re 3-1. Numbe r of issues pe r issue ca te go ry colle cted b y FEED BACK CDRH (Ma rch 2015 to April 2018) .. 12 Fi gu re 3-2. Pe rcenta ge of closed prema rke t re view issues from Nove mbe r 2016 to April 13 Fi gu re 3-3. Booz Allen s hi gh-le vel ove rview of the I T s yste m e nhancement process .. 15 Fi gu re 3-4. Numbe r of unique visi tors to CDRH DCS from Ma y 2017 to April 16 Fi gu re 3-5. Summa ry results of the audi t of SOP cri teria in ma jor, minor, and new transmi ttal noti 17 Fi gu re 3-6.

5 Results of Booz Allen s 510(k) audit for adherence to Administra ti ve File procedures by fiscal 17 Fi gu re 3-7. Staff survey responses on timing and length of RCP .. 24 Fi gure 3-8. Staff survey responses on RCP s training content .. 25 Fi gu re 3-9. Survey re spondents agreement with the statement: I have u sed th e insigh ts fro m my ELP e xp erien ce while co n ducting submission reviews .. 25 Fi gu re 3-10. Surve y respondents a greement wi th the s ta te me n t : I woul d l i ke to pa r ti ci pa te i n m o re E L P op po r tu ni ti e 26 Fi gu re 3-11. Survey re spondents agreement with the statement: LEAD Program classes have helped me to develop better management te chniq ues .. 26 Fi gu re 3-12.

6 Su rvey re spon dents agreement with the statement: After attending RCP, I could effectively navigate, a ccess and use the CDRH I T s ys tems (e .g., DocMan, CTS, I mage 2000+) to pe rform a 510(k) re view .. 27 Fi gu re 3-13. Number of informal training events and pa rti cipants tha t obtained credi t from FY2015 to FY2017 .. 29 Fi gu re 3-14. Percenta ge of submissions recei ving fi rst-cycle RTA1 by fiscal yea r .. 31 Fi gu re 3-15. RTA cycles to a cceptance by fiscal yea 31 Fi gu re 3-16. Nu mbe r of missing elemen ts in bo th fi rst-ro und RTAA and RTA1 Che cklists from FY2015 to FY2017 .. 32 Fi gu re 3-17. Top ca tegories of missing elements in fi rst-round RTAA Che cklists in FY2015 to FY2017.

7 32 Fi gu re 3-18. Top ca tegories of missing elements in fi rst-round RTA1 Che cklists in FY2015 to FY2017 .. 33 Fi gu re 3-19. Withdrawal ra te of all a ccepted 510(k)s by fiscal yea r, as published in the September 2018 MDUFA III Performance Report .. 35 Fi gu re 3-20. Withdrawal ra te of a ccepted Traditional 510(k)s by fiscal yea r .. 35 Fi gu re 3-21. Timing of wi thdrawals in Tradi tional 510(k)s by fiscal yea r .. 36 Fi gu re 3-22. Reasons for wi thdrawal by review 36 Fi gu re 3-2 3 . A ve ra ge f re q u e n c y o f CDR H-sponsor intera ctions by fiscal yea r .. 38 Fi gu re 3-24. Timing of firs t interacti ve request by fiscal year .. 39 Fi gu re 3-25. Nu mbe r of sub missions u nde rgoing e Cop y holds b y nu mbe r o f holds and calenda r yea r.

8 41 Fi gu re 3-26. Percenta ge of submissions with identi fied review a ttributes by goal sta tus .. 43 Fi gu re 3-27. ODE adoption of SMART memo by fiscal 46 Fi gu re 3-28. Survey re spondents agreement with the statement: The 510(k) SMART memo te mplate has improve d th e co nsistency o f 510(k) re vie 46 Fi gu re 3-29. Su rvey re sponses to th e q uestion : Which (if any) of the following changes to the 510(k) SMART memo te mplate would be benefi cial? (select all that appl y).. 47 Fi gu re 3-30. Documentation of consul t recommenda tions in Lead Reviewer memo by fiscal year .. 48 Fi gu re 3-31. Survey re spondents agreement with the statemen t: In recen t years, my managers have pro vided co nsisten t feedback a nd/or oversight for the memos and letters I wrote during interi m and final steps of prema rket review.

9 48 Fi gu re 3-32. Survey respondents agreement with the statement: The Biocompatibility Focal Point Program (FPP) has improved the consistency of biocompatibility reviews and consults .. 49 Fi gu re 3-33. Su rvey re sponses to th e q uestion : Which (if any) ch anges to th e MD UFA p remark et sub mission co nsult p ro cess would b e bene fi cial (fo r consul ts within or a cross CDRH di vision and offices ; excluding consults to/from CBER or CDER)? (select all that appl y) .. 50 Fi gu re 3-34. Top 10 re viewe r designa ted ca tegories of AI lette r de ficiencies .. 51 Fi gu re 3-35. Su rvey re sponses to th e q uestion : Which (if any) o f the following would positively i mpact premarket review decision-making consistency?

10 (select all that appl y).. 51 Fi gu re 5-1. Numbe r of Tradi tional 510(k)s in the FY2015 FY2017 Receipt Cohort and each MDUFA Audit Cohort by division .. 56 T h is documen t is confid ential and intende d sol ely for the cl ien t to w hom it is a ddressed. iii List of Tables Ta bl e ES-1. Summa ry of recommenda tions for FDA implementa tion completed a gainst Booz Allen evalua tion fra 2 Ta bl e ES-2. Outcomes of FDA implementa tion plans .. 3 Ta bl e 2-1 . De s c ri p ti o n of da ta s ou r ce s f r om CD RH da ta s ys te ms .. 7 Ta bl e 2-2. Summa ry of Tradi tional 510(k) cohorts and associated anal 8 Ta bl e 2-3. Distribution of transmi ttal noti ces in audi t of CDRH s QM s ystems.