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New England District UpdateFDA’s Office of Regulatory Affairs Aligns for the Future
MassMedicDecember 12, 2017
Waltham, MAJoseph S. Matrisciano Jr, JD, PEDirector, New England District
Director, Office of Medical Products and Radiological Health Operations Division 1
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“…MODERNIZE AND STRENGTHEN THE FDA WORKFORCE TO
IMPROVE PUBLIC HEALTH RESPONSE.”
2013 FDA PROGRAM ALIGNMENT CHARGE
FDA’S OFFICE OF REGULATORY AFFAIRS
ALIGNS FOR THE FUTURE
www.fda.gov
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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
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Office of Medical Products and
Tobacco Operations
Ellen Morrison
Assistant Commissioner Office of Medical Products and Tobacco
Operations
Alonza Cruse Director, Office of Pharmaceutical Quality Operations
Jan Welch Director, Office of
Medical Device and
Radiological Health Operations
Chrissy Cochran, PhD Director,
Office of Bioresearch Monitoring Operations
Ginette Michaud, MD Director,
Office of Biological Products
Operations
Director Tobacco Staff
[vacant]
www.fda.gov
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7www.fda.gov
Office of Medical Device and Radiological
Health Operations
Jan Welch
Director, Office of
Medical Device
and Radiological Health
8www.fda.gov
Office of Medical Device and Radiological Health
Operations
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10
229
1,049
3,395
4,057
258
New England District Domestic Inventory
Center for Biologics Evaluation and Research (CBER) Center for Drugs Evaluation and Research (CDER)
Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN)
Center for Veterinary Medicine (CVM)
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NWE-DO/MDRHE AccomplishmentsFY 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
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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
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Compliance ActionsDomestic 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
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IMPORT LINES - NATIONWIDE (FY17)
CDRH (49%)
CFSAN (47%)
CDER (2%)
CVM (1%)
CTP (< 1%)
CBER (< 1%)
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IMPORT LINES – NWE-DO (FY17)
CFSAN (55%)
CDRH (38%)
CVM (5%)
CDER (2%)
CBER (< 1%)
CTP (< 1%)
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TOP TEN CDRH IMPORTED PRODUCTSFY17 – ALL DISTRICTS
0
500,000
1,000,000
1,500,000
2,000,000
2,500,000
Surgical Drape(KKK)
Surgical Gown(FYA)
Piston Syringe(FMF)
Scalpel Blade(GES)
NonabsorableGauze (GDY)
Emesis Basin(FNY)
ProtectiveBarrier Cover
(MMP)
ElectrosurgicalDevice (GEI)
HypodermicNeedle (FMI)
AbsorbentMedical Fiber
(FRL)
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TOP TEN CDRH IMPORTED PRODUCTSFY17 – NWE-DO
0
5,000
10,000
15,000
20,000
25,000
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Shipments by Country of OriginImports FY17 (NWE-DO)
TOTAL LINES: 673,050 DEVICE LINES: 258,414
39%Canada
29%GERMANY
12%Germany
27%SWITZERLAND
11%Switzerland
15%IRELAND
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Final Admissibility DecisionsImports 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
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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:
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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
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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
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Recalls FY 17 ExamplesDevice
• 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.
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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 Staff Director Rhonda Mecl
(Acting)
OMDRHO/Foreign MedicalDevices and RadiologicalHealth Inspection Staff
Staff Director Dorothy Lee
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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
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Office of Medical Device and Radiological Health
OperationsDivision 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
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Office of Medical Device and Radiological Health
OperationsDivision 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
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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
www.fda.gov
Jessica Zeller, JD, MA
Ombudsman
PUBLIC HEALTH
PARTNERSHIPS:
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.
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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
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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
• Partnerships
www.fda.gov
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Resources and Contacts
• OMDRHO Division Inspectional Handouts• Division 1:
• Division 2:
• Division 3:
• Presenter: Joe Matrisciano Email: [email protected]
Telephone: 781-587-7490
www.fda.gov
