New England District Update - MassMEDIC...New England District Update FDA’s Office of Regulatory...

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

– ORAOmbudsman@fda.hhs.gov

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

– engageORA@fda.hhs.gov

• Partnerships

– OP-ORA@fda.hhs.gov

www.fda.gov

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Resources and Contacts

• OMDRHO Division Inspectional Handouts• Division 1:

• Division 2:

• Division 3:

• Presenter: Joe Matrisciano Email: joseph.matrisciano@fda.hhs.gov

Telephone: 781-587-7490

www.fda.gov