Top 10 Medical Device Citations Regina A. Barrell Food and Drug Administration Office of Regulatory Affairs Office of Enforcement Division of Compliance Management and Operations QSIT Approach to Inspections Level 1 – Abbreviated – 2 subsystems; Corrective and Preventive Actions (CAPA) plus Production and Process Controls (P & PC) or Design Controls. QSIT Approach to Inspections Level 2 – Comprehensive – 4 major subsystems; Management Controls, Design Controls, CAPA and P & PC. QSIT Approach to Inspections Level 3 – Compliance Follow-Up – Special – For Cause – Special – Risk Based Work Plan As directed by inspectional guidance and elements of QSIT. QSIT Approach to Inspections Compliance Follow-Up, For Cause and Risk Based Work Plan are dictated by the previous FDA-483 findings and other regulatory information and may differ from the typical QSIT approach. 2011 1. 820.100(a) – Corrective and Preventive Action (Procedures) 2. 820.198(a) – Complaint procedures 3. 803.17 – Written MDR procedures 4. 820.100(b) – Corrective and Preventive Action (Documentation) 5. 820.75(a) – Process Validation 2011 6. 820.181 – Device Master Record 7. 820.50 – Purchasing Controls 8. 820.90 (a) – Control of non-conforming product 9. 820.22 – Quality Audit procedures 10. 820.30 (i) – Design Change procedures Total Turbo Citations vs. 2011 Citations Total 2011 1 820.100(a) 820.100(a) 2 803.17 820.198(a) 3 820.198(a) 803.17 4 820.100(b) 820.100(b) 5 820.75(a) 820.75(a) Total Turbo Citations vs. 2011 Citations Total 2011 6 820.22 820.181 7 820.22 820.50 8 820.30(a) 820.90(a) 9 820.30(i) 820.22 10 820.50 820.30(i) TOP FIVE FDA 483 CITATIONS FOR MEDICAL DEVICE FIRMS Number One 21 CFR 820.100(a) Procedures for corrective and preventive action have not been [adequately] established. 21 CFR 820.100(a) For example: Failure to analyze processes, service records, quality audit reports, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product; 21 CFR 820.100(a) contd. Cause of nonconformities relating to product, processes and the quality system are not investigated; Actions needed to correct and prevent recurrence of nonconforming product or other quality problems are not identified. TOP FIVE FDA 483 CITATIONS FOR MEDICAL DEVICE FIRMS Number Two 21 CFR 820.198(a) Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established. 21 CFR 820.198(a) For example: Complaints are not processed in a uniform or timely manner; are not documented; or have not been evaluated for MDR applicability. TOP FIVE FDA 483 CITATIONS FOR MEDICAL DEVICE FIRMS Number Three 21 CFR 803.17 Written MDR procedures have not been [developed] [maintained] [implemented]. 21 CFR 803.17 For example: Your firm’s Complaint Handling procedure states that complaints shall be reviewed for MDR reporting per 21 CFR 803, however there are no additional MDR procedures. 21 CFR 803.17 contd. For example: Your procedure does not contain a standardized process for determining when an event meets the criteria for MDR. There are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner. TOP FIVE FDA 483 CITATIONS FOR MEDICAL DEVICE FIRMS Number Four 21 CFR 820.100(b) Corrective and preventive action activities and/or results have not been [adequately] documented. TOP FIVE FDA 483 CITATIONS FOR MEDICAL DEVICE FIRMS Number Five 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. 21 CFR 820.75(a) For example: Storage conditions were not defined or monitored for the chemical indicators used in the Ethylene Oxide validation study as well as during routine processing. 21 CFR 820.75(a) contd. For example: There is no process validation study for the radio frequency welding process used to weld flanges onto the bladder that is a component of the X device. FDA Enforcement Statistics Summary Fiscal Year 2011 Seizures 15 Injunctions 16 Warning Letters 1720 Recall Events 3640 Recalled Products 9288 Debarments 16 CDRH Enforcement Statistics Summary Fiscal Year 2011 Seizures 1 Injunctions 0 Warning Letters 175 Recall Events 1,271 Recalled Products 3,211 CDRH Seizures By Fiscal Year 2007 - 2011 2 2 1 1 1 0 0 2007 2008 2010 2011 CDRH Injunctions By Fiscal Year 4 4 3 2 2 1 1 0 0 2007 2008 2010 2011 CDRH Warning Letters By Fiscal Year 225 204 200 175 175 155 152 2007 2008 150 125 100 75 50 25 0 2010 2011 Total Recall Events by CDRH Fiscal Year 2007 - 2011 1400 1,271 1200 1000 800 831 876 2008 2010 664 600 400 200 0 2007 2011 Class I, II and III Total Recall Products by CDRH Fiscal Year 2007 - 2011 3500 3,211 3000 2,472 2500 2,634 2000 1500 1,279 1000 500 0 2007 2008 2010 2011 Class I, II and III FDA Recalls – All Classes Fiscal Year 2007 - 2011 3500 3,211 3000 2,472 2500 2,634 2000 1500 1000 1,279 664 1,271 831 876 2008 2010 500 0 2007 Events 2011 Products Recalls: Definition of Class I Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. CDRH Class I Recalls – Fiscal Year 2007 - 2011 450 400 350 300 250 200 150 100 50 0 427 334 131 26 45 14 2007 2008 49 50 2010 2011 Events Products Recalls: Definition of Class II Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. CDRH Class II Recalls – Fiscal Year 2007 - 2011 3000 2,665 2500 2,178 2,208 2000 1500 1000 1,151 1,102 540 709 753 2008 2010 500 0 2007 Events 2011 Products Recalls: Definition of Class III Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. CDRH Class III Recalls – Fiscal Year 2007 - 2011 180 160 140 120 100 80 60 40 20 0 163 132 98 2007 119 108 92 2008 74 70 2010 2011 Events Products QUESTIONS??