New England District Update FDA s Office of Regulatory Affairs Aligns for the Future MassMedic December 12, 2017 Waltham, MA Joseph S. Matrisciano Jr, JD, PE Director, New England District Director, Office of Medical Products and Radiological Health Operations Division 1
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FDA S OFFICE OF REGULATORY AFFAIRS ALIGNS FOR THE FUTURE MODERNIZE AND STRENGTHEN THE FDA WORKFORCE TO IMPROVE PUBLIC HEALTH RESPONSE. 2013 FDA PROGRAM ALIGNMENT CHARGE www.fda.gov 3
ORA Program Divisions Office of Bioresearch Monitoring Operations (OBIMO) Office of Biological Products Operations (OBPO) Office of Medical Device and Radiological Health Operations (OMDRHO) Office of Pharmaceutical Quality Operations (OPQO) Office of Human and Animal Food Operations (OHAFO) Office of Enforcement and Import Operations (OEIO) Tobacco Operations Program 4
Office of Medical Products and Tobacco Operations Ellen Morrison Assistant Commissioner Office of Medical Products and Tobacco Operations Director Tobacco Staff [vacant] Ginette Michaud, MD Director, Office of Biological Products Operations Chrissy Cochran, PhD Director, Office of Bioresearch Monitoring Operations Jan Welch Director, Office of Medical Device and Radiological Health Operations Alonza Cruse Director, Office of Pharmaceutical Quality Operations www.fda.gov 5
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Office of Medical Device and Radiological Health Operations Jan Welch Director, Office of Medical Device and Radiological Health www.fda.gov 7
Office of Medical Device and Radiological Health Operations www.fda.gov 8
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New England District Domestic Inventory 258 229 1,049 4,057 3,395 Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Veterinary Medicine (CVM) Center for Drugs Evaluation and Research (CDER) Center for Food Safety and Applied Nutrition (CFSAN) 10
NWE-DO/MDRHE Accomplishments FY 17 From 10/1/16 5/14/17 for New England states only Completed 78 domestic medical device inspections From 5/15 9/30/17 for MDRHE Completed 188 domestic medical device inspections 11
FY 17 FDA-483 Observations Top 5 medical device observations nationally 1. Inadequate establishment of CAPA procedures, 21 CFR 820.100(a) 2. Inadequate establishment of complaint procedures, 21 CFR 820.198(a) 3. Inadequate process validation, 21 CFR 820.75(a) 4. Inadequate purchasing controls, 21 CFR 820.50 5. Inadequate MDR procedures, 21 CFR 803.17 12
Compliance Actions Domestic FY17 Warning Letters FY 17 NWE WL s (10/1/16 5/14/17) 9 total 4 device FY 17 MDRHE WL s (5/15 9/30/17) 3 device Reg Meetings FY 17 NWE - 1 device FY 17 MDRHE 3 device Injunctions - 0 13
IMPORT LINES - NATIONWIDE (FY17) CDRH (49%) CFSAN (47%) CDER (2%) CVM (1%) CTP (< 1%) CBER (< 1%) 14
IMPORT LINES NWE-DO (FY17) CFSAN (55%) CDRH (38%) CVM (5%) CDER (2%) CBER (< 1%) CTP (< 1%) 15
TOP TEN CDRH IMPORTED PRODUCTS FY17 ALL DISTRICTS 2,500,000 2,000,000 1,500,000 1,000,000 500,000 0 Surgical Drape Surgical Gown Piston Syringe (KKK) (FYA) (FMF) Scalpel Blade (GES) Nonabsorable Gauze (GDY) Emesis Basin (FNY) Protective Electrosurgical Barrier Cover Device (GEI) (MMP) Hypodermic Needle (FMI) Absorbent Medical Fiber (FRL) 16
TOP TEN CDRH IMPORTED PRODUCTS FY17 NWE-DO 25,000 20,000 15,000 10,000 5,000 0 17
Shipments by Country of Origin Imports FY17 (NWE-DO) TOTAL LINES: 673,050 DEVICE LINES: 258,414 39% Canada 29% GERMANY 12% Germany 27% SWITZERLAND 11% Switzerland 15% IRELAND 18
Final Admissibility Decisions Imports FY17 (NWE-DO) DECISION ALL LINES DEVICE LINES May-Proceeds 663,053 257,507 Releases 4,004 228 Releases after Detention 242 61 Refusals 285 46 TOTALS: 669,152 257,842 19
Compliance Actions Imports FY17 (NWE-DO) 48 total Import Alert (IA) recommendations for NWE-DO ports of entry IAs provide guidance to the field that FDA has sufficient evidence to Detain Without Physical Examination (DWPE). 7 of these recommendations were related to device/electronic products and for the following alerts: 20
Import Alerts FY17 (NWE-DO) Import Alert 80-04, Surveillance and DWPE of Surgeon s and Patient Examination Gloves (three cases) Import Alert 89-08, DWPE of Class III Devices Without Approved PMA's or IDE's and Other Devices Not Equivalent or No 510k (two cases) Import Alert 89-17, DWPE of Medical Devices that appear to be adulterated because their quality falls below that which they purport or are represented to possess Import Alert 95-05, DWPE of Electronic Products that fail to comply with Performance Standards or no certification 21
NWE/MDRHE FY 2017 Recalls From 10/1/16 5/14/17 for New England states only and from 5/15 9/30/17 for MDRHE 152 Device 6 Class I 103 Class II 5 Class III 3 Market Withdrawal 22
Device Recalls FY 17 Examples Class I Lead Blood Test Kits, underestimates the lead concentration of venous blood samples. Class II Patient monitoring cable, manufacturing defect may cause localized heating, which may result in localized skin burn. Class III Fluorometer, for clinical use, potential plate loading failures. 23
Office of Medical Device and Radiological Health Operations Immediate Office Office Title Name OMDRHO Director Jan Welch OMDRHO Deputy Director Anne Reid OMDRHO Special Assistant Kristina Donohue OMDRHO QMS Manager Lynne Dwyer OMDRHO Training Officer Monica Forrest OMDRHO/Medical Device and Radiological Health Staff Operations OMDRHO/Foreign Medical Devices and Radiological Health Inspection Staff Staff Director Staff Director Rhonda Mecl (Acting) Dorothy Lee 24
Office of Medical Device and Radiological Health Operations Division I Office Title Name Coverage OMDRHO Division I Division Director/Program Division Director Joseph S. Matrisciano Jr NWE/BLT/CIN/DET/NWJ/NYK/PHI OMDRHO Division I Compliance Branch Director Gina Brackett (Acting) NWE/BLT/CIN/DET/NWJ/NYK/PHI OMDRHO Division I Investigations Branch Director Arduino Frankovic NWE/BLT/CIN/DET/NWJ/NYK/PHI 25
Office of Medical Device and Radiological Health Operations Division II Office Title Name Coverage OMDRHO Division II Program Division Director Kathleen Sinninger (Acting) FLA/ATL/CHI/KAN/MIN/NOL/SJN OMDRHO Division II Compliance Branch Director Blake Bevill FLA/ATL/CHI/KAN/MIN/NOL/SJN OMDRHO Division II Investigations Branch Director Travis Chapman (Acting) FLA/ATL/CHI/KAN/MIN/NOL/SJN 26
Office of Medical Device and Radiological Health Operations Division III Office Title Name Coverage OMDRHO Division III Program Division Director Shari Shambaugh (Acting) LOS/DAL/DEN/SAN/SEA OMDRHO Division III Compliance Branch Director Kelly Sheppard LOS/DAL/DEN/SAN/SEA OMDRHO Division III Investigations Branch Director Eric Anderson (Acting) LOS/DAL/DEN/SAN/SEA 27
ORA Ombudsman Informally and impartially addresses concerns, complaints, and disputes between ORA and external parties: Industry Federal, state, territory, and tribal government entities Public Contact: 513-679-2777 or 240-535-6021 ORAOmbudsman@fda.hhs.gov Jessica Zeller, JD, MA Ombudsman PUBLIC HEALTH PARTNERSHIPS: www.fda.gov Enhancing ORA operations by serving as an objective, neutral resource to improve communication channels, resolve disputes, and foster positive relationships with internal and external stakeholders. 28
What s Next Complete the structural changes Continue to advance operational change (e.g.) Updated training programs & subspecialties Revamp work planning National operations SOPs Continuous Improvement 29
Resources and Contacts www.fda.gov/ora ORA Organization Charts and Boundary Maps Fact Sheets ORA s New Structure Operational Offices Investigations Operations Manual Headquarters, District/Division Contact Information ORA Contacts State and local inquiries District Director/Program Division Directors State Liaison General Inquiries engageora@fda.hhs.gov Partnerships OP-ORA@fda.hhs.gov www.fda.gov 30
OMDRHO Division Inspectional Handouts Division 1: Resources and Contacts Division 2: Division 3: Presenter: Joe Matrisciano Email: joseph.matrisciano@fda.hhs.gov Telephone: 781-587-7490 www.fda.gov 31