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 6 th, 2016 - Utah Life Science Summit With thanks to Bryan Love, Medical Device Supervisory Consumer Safety Officer, Denver District
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 2
2016-2017 CDRH Strategic Priorities Establish a National Evaluation System for Medical Devices 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 Partner with Patients 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 Promote a Culture of Quality and Organizational Excellence 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 3
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) 4
Device Identification Unique Device Identifier (UDI) Rule When: September 24 th, 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). 5
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 6
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 7
Example UDI = DI + PI 8
Device Identifier (DI) 9
Production Identifier (PI) 10
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. 11
Link to UDI website http://www.fda.gov/medicaldevices/deviceregulationandguidance/ UniqueDeviceIdentification/default.htm 12
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) 13
These are Not Packages and Do Not Require a UDI Wrapping intended to protect Pallets Crates 14
Compliance Dates for UDI Requirements 15
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 16
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Link to GUDID Guidance http://www.fda.gov/medicaldevices/deviceregulationandguidance/unique DeviceIdentification/GlobalUDIDatabaseGUDID/ucm416106.htm 18
Top 4 Medical Device Observations Fiscal FY15 vs. FY16 Fiscal Year* Count Reference No. Citation Text FY16 309 FY15 394 FY16 233 FY15 308 21 CFR 820.100(a) 21 CFR 820.198(a) Procedures for corrective and preventive action have not been [adequately] established. Specifically, *** Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established. Specifically,*** FY16 130 21 CFR 803.17 FY15 144 21 CFR 820.75(a) FY16 124 21 CFR 820.90(a) FY15 141 21 CFR 820.50 Written MDR procedures have not been [developed] [maintained] [implemented]. Specifically, *** A process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] validated according to established procedures. Specifically, *** Procedures have not been [adequately] established to control product that does not conform to specified requirements. Specifically, *** 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 1 st to September 30 th. 19
Top 4 Drug Observations Fiscal FY15 vs. FY16 Fiscal Year Count Reference No. Citation Text FY16 124 FY15 173 FY16 118 FY15 137 FY16 116 FY15 128 21 CFR 211.22(d) 21 CFR 211.160(b) 21 CFR 211.192 The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, *** 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, *** 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, *** FY16 79 21 CFR 211.68(a) FY15 112 21 CFR 211.113(b) Routine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance. Specifically, *** Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed]. Specifically, *** 20
Questions? 21