FDA’s Office of Regulatory Affairs: Violation Trends & Medical Device Update

Ginger M. Sykes Supervisory Consumer Safety Officer

Salt Lake City Resident Post Office of Regulatory Affairs

U.S. Food and Drug Administration ginger.sykes@fda.hhs.gov

October 6th, 2016 - Utah Life Science Summit

With thanks to Bryan Love, Medical Device Supervisory Consumer Safety Officer, Denver District

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Agenda • 2016-2017 Center for Devices & Radiological Health

Strategic Priorities

• Unique Device Identification (UDI) Requirements – Labeling – Data Submission

• Violation Trends (Medical Device & Drug)

www.fda.gov

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2016-2017 CDRH Strategic Priorities • Goal: Increase access to real-world evidence to support

regulatory decision making • Goal: Increase the use of real-world evidence to support

regulatory decision making

Establish a National Evaluation System for

Medical Devices

• Goal: Promote a culture of meaningful patient engagement by facilitating CDRH interaction with patients • Goal: Increase use and transparency of patient input as evidence in our decision making

Partner with Patients

• Goal: Strengthen FDA’s culture of quality within the Center for Devices and Radiological Health

• Goal: Strengthen product and manufacturing quality within the medical device ecosystem

Promote a Culture of Quality and Organizational

Excellence

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Establish a National Evaluation System for Medical Devices

GOAL: INCREASE ACCESS TO REAL WORLD EVIDENCE TO SUPPORT REGULATORY DECISION MAKING • By December 31, 2016, gain access to 25 million electronic patient records (from national

and international clinical registries, claims data, and EHRs) with device identification. • By December 31, 2017, gain access to 100 million electronic patient records with device

identification.

GOAL: INCREASE THE USE OF REAL-WORLD EVIDENCE TO SUPPORT REGULATORY DECISION MAKING • By December 31, 2016, increase by 40 percent the number of premarket and postmarket

regulatory decisions that leverage real-world evidence (compared to FY2015 baseline) • By December 31, 2017, increase by 100 percent the number of premarket and postmarket

regulatory decisions that leverage real-world evidence (compared to FY2015 baseline)

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Device Identification Unique Device Identifier (UDI) Rule

• When: September 24th, 2013 – Final Rule – 78 FR 58786

• What is it: It requires the labels and device packages of medical devices distributed in the United States include a unique device identifier (UDI), unless we grant an exception or alternative to UDI label requirements.

• Additional Requirements: Product information will need to be submitted to FDA’s Global Unique Device Identification Database (known as the GUDID).

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Health Objectives served by the UDI Rule: • A way to obtain accurate information about a device • Ability to readily access important information – hence reducing

medical errors • More accurate reporting, reviewing, and analyzing of AE reports • Provides a standard and clear way to document device use in

electronic health records, clinical information systems, claims data sources and registries

• Enable manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls

• Provides a foundation for a global, secure distribution chain that will help address counterfeiting and diversion, and prepare for medical emergencies

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What is a UDI? 21 CFR 830.3 Unique Device Identification Found on the device label, packaging or, in some cases,

on the device itself Both in plain text and machine readable format (AIDC) Identifies device through distribution & use

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Example UDI = DI + PI

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Device Identifier (DI)

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Production Identifier (PI)

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How do I get a UDI? • You have to go through an Issuing Agency (21 CFR 830)

– An issuing agency operates a system for issuing UDIs to labelers.

– The UDI rule requires all UDIs to be issued under a system operated by an FDA-accredited issuing agency.

– FDA accreditation requires that the issuing agency’s system conforms to certain international consensus standards.

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Link to UDI website http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm

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Issuing Agencies • Currently there are three FDA accredited Issuing

Agencies to choose from: – GS1 (initial accreditation granted through: December 17,

2016) – Health Industry Business Communications Council (HIBCC)

(initial accreditation granted through: December 26, 2016) – ICCBBA (initial accreditation granted through: February 12,

2017)

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These are Not Packages and Do Not Require a UDI

Wrapping intended to protect

Pallets Crates

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Compliance Dates for UDI Requirements

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Global Unique Device Identification Database (GUDID)

• Repository of key device identification information • Contains ONLY the DI • PIs are not submitted to or stored in the GUDID

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Link to GUDID Guidance http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/ucm416106.htm

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Top 4 Medical Device Observations Fiscal FY15 vs. FY16

Fiscal Year* Count Reference No. Citation Text

FY16 309 21 CFR 820.100(a) Procedures for corrective and preventive action have not been

[adequately] established. Specifically, *** FY15 394

FY16 233 21 CFR 820.198(a)

Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established. Specifically,*** FY15 308

FY16 130 21 CFR 803.17 Written MDR procedures have not been [developed] [maintained] [implemented]. Specifically, ***

FY15 144 21 CFR 820.75(a) A process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] validated according to established procedures. Specifically, ***

FY16 124 21 CFR 820.90(a) Procedures have not been [adequately] established to control product that does not conform to specified requirements. Specifically, ***

FY15 141 21 CFR 820.50 Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been [adequately] established. Specifically, ***

*Fiscal Year is from October 1st to September 30th.

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Top 4 Drug Observations Fiscal FY15 vs. FY16

Fiscal Year Count Reference No. Citation Text

FY16 124 21 CFR 211.22(d)

The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, ***

FY15 173

FY16 118

21 CFR 211.160(b)

Laboratory controls do not include the establishment of scientifically sound and appropriate [specifications] [standards] [sampling plans] [test procedures] designed to assure that [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] conform to appropriate standards of identity, strength, quality and purity. Specifically, ***

FY15 137

FY16 116

21 CFR 211.192 There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed. Specifically, *** FY15 128

FY16 79 21 CFR 211.68(a) Routine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance. Specifically, ***

FY15 112 21 CFR 211.113(b) Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed]. Specifically, ***

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Questions?