Device Initiatives FY 2005 Karen A. Coleman FDA Device National Expert

Device InitiativesDevice InitiativesFY 2005FY 2005

Karen A. ColemanKaren A. Coleman

FDA Device National ExpertFDA Device National Expert

Device Initiative TopicsDevice Initiative Topics

Accredited Persons Inspection ProgramAccredited Persons Inspection Program

Device Certification ProgramDevice Certification Program

Enforcement InitiativesEnforcement Initiatives RecallsRecalls Warning Letters, Untitled letters, FY ’04 ActionsWarning Letters, Untitled letters, FY ’04 Actions GMP / 483’sGMP / 483’s Single Use Devices [SUD] Reprocessed by Third Single Use Devices [SUD] Reprocessed by Third

Parties and HospitalsParties and Hospitals

ACCREDIATED PERSONS ACCREDIATED PERSONS AUDIT PROGRAMAUDIT PROGRAM

Accredited Persons [AP] Audit Accredited Persons [AP] Audit Program Key DatesProgram Key Dates

10/26/02 – MDUFMA signed into law10/26/02 – MDUFMA signed into law

10/25/03 – Top 15 AP’s listed10/25/03 – Top 15 AP’s listed

1/12/04 – FDA AP Training1/12/04 – FDA AP Training

04/28/04 – New AP applications accepted04/28/04 – New AP applications accepted

05/2005 – Possible date next FDA Training05/2005 – Possible date next FDA Training

Accredited Persons Audit ProgramAccredited Persons Audit Program

8 AP’s completed 3 performance audits for 8 AP’s completed 3 performance audits for MRA and meet AP requirements. MRA and meet AP requirements. May conduct independent audits for FDAMay conduct independent audits for FDA

4 AP’s completed 1 or 2 performance 4 AP’s completed 1 or 2 performance audits under MRA. Additional audits under MRA. Additional requirements needed.requirements needed.

19 AP’s completed1 out of 3 performance 19 AP’s completed1 out of 3 performance auditsaudits

Accredited Persons Audit ProgramAccredited Persons Audit Program

2 AP’s have 2 out of 3 performance audits2 AP’s have 2 out of 3 performance audits

20 AP’s need the 3 performance audits20 AP’s need the 3 performance audits

6 people no longer participate 6 people no longer participate

Accredited Persons Web ReferencesAccredited Persons Web References

http://www.fda.gov/cdrh/ap-inspection/ap-inshttp://www.fda.gov/cdrh/ap-inspection/ap-inspection.htmlpection.html

http://www.fda.gov/cdrh/thirdparty/thirdparty-http://www.fda.gov/cdrh/thirdparty/thirdparty-how.htmlhow.html

http://www.fda.gov/cdrh/mdufma/aprating.hthttp://www.fda.gov/cdrh/mdufma/aprating.htmlml

http://www.fda.gov/cdrh/mdufuma/http://www.fda.gov/cdrh/mdufuma/guidance/1200/htmlguidance/1200/html

Device CertificationDevice Certification


Certified Device Investigators = 55Certified Device Investigators = 55

Total certified since implementation Total certified since implementation 130130

Device Auditors = 37Device Auditors = 37


Device Certification Work ProgramsDevice Certification Work Programs

Domestic AuditsDomestic Audits

MRA’sMRA’s

APAP

ENFORCEMENT ENFORCEMENT INITIATIVESINITIATIVES

RECALLSRECALLSFDA

0

50

100150

200

250

300350

400

FY 2001 = 555

Class 1 = 7

Class 2 = 395

Class 3 = 153

Safety Alerts= 4

Recall Actions FY 2001Recall Actions FY 2001


0

100

200

300

400

500

FY 2002 = 634

Class 1 = 15

Class 2 = 467

Class 3 = 146

Safety Alerts= 6


0

100

200

300

400

500

FY 2003 = 608

Class 1 = 7

Class 2 = 460

Class 3 = 141

Safety Alerts= 9


0

100

200

300

400

500

FY 2004 = 638

Class 1 = 23

Class 2 = 473

Class 3 = 142

Safety Alerts= 13

9 8 8 7 7 6 5 4 4 4 620

10

20

30

40

50

60

70

1

2004 Top Ten Product Recalls

Cut Coag

Nuc MRI

Auto Ext Defib

X-Ray Angio

Chem Analy

AC Hosp Bed

Biliary Diag Cath

Infusion Pump

Shrt Trm IV

Dif Cell Ctr

Total

Device Packaging Recalls ‘04Device Packaging Recalls ‘04

22 Recalls due to Packaging Failures22 Recalls due to Packaging Failures

Cause by 3 Failure ModesCause by 3 Failure Modes Packaging Design/ Selection [10]Packaging Design/ Selection [10] Packaging Change Control [1]Packaging Change Control [1] Packaging Process Control [11]Packaging Process Control [11]

Device Labeling Recalls ‘04Device Labeling Recalls ‘04

59 Recalls due to labeling failures59 Recalls due to labeling failures

Caused by 4 failure modesCaused by 4 failure modes Labeling Mix-ups/Errors [15]Labeling Mix-ups/Errors [15] Labeling Design [3]Labeling Design [3] Labeling Change Control [10]Labeling Change Control [10] Labeling False and Misleading [31]Labeling False and Misleading [31]


WARNING LETTERSWARNING LETTERS

UNTITLED LETTERSUNTITLED LETTERS

FY’04 ACTIONSFY’04 ACTIONS

FY 2004 Warning Letters = 218FY 2004 Warning Letters = 218

Warning Letter Reasons3 44

76

456

2452

11

Inadq Dir

MDR's

Misbrd

GMP's

510k Nok

510k App

Perf Stds

FY 2004 Untitled Letters = 108FY 2004 Untitled Letters = 108

Untitled Letter Reasons

MDR Misbrd510k Nok

510k App

Perf Stds

FY 2004 Device Legal ActionsFY 2004 Device Legal Actions

2 Seizures2 Seizures

2 Injunction Recommendations2 Injunction Recommendations 1 filed1 filed 1 in litigation1 in litigation

2 Civil Money Penalties2 Civil Money Penalties


GMP /483 Citation TOP TENGMP /483 Citation TOP TEN

GMP / 483 Top TenGMP / 483 Top Ten

1.1. 820.198 Complaint handling procedures for 820.198 Complaint handling procedures for [rec.] [reviewing] [eval.] complaints have not [rec.] [reviewing] [eval.] complaints have not been [est.] [defined] [doc.] [completed] been [est.] [defined] [doc.] [completed] [implemented]……….[implemented]……….

2.2. 820.100(a) Procedures for implementing 820.100(a) Procedures for implementing corrective and preventive actions were not [est.] corrective and preventive actions were not [est.] [defined] [doc.] [complete] [implemented ] [defined] [doc.] [complete] [implemented ] ……….……….


3.3. 803.17 Written MDR procedures have not 803.17 Written MDR procedures have not been [developed] [maintained] been [developed] [maintained] [implemented]……………[implemented]……………

4.4. 820.22 Quality Audits were not conducted 820.22 Quality Audits were not conducted [at sufficient regular intervals, as [at sufficient regular intervals, as prescribed by internal procedures] to verify prescribed by internal procedures] to verify that the quality system is effective in that the quality system is effective in fulfilling your quality system objectives ….. fulfilling your quality system objectives …..


5.5. 820.100(b) Corrective and preventive 820.100(b) Corrective and preventive action activities have not been action activities have not been documented including …………………documented including …………………

6.6. 820.75(a) A process whose results 820.75(a) A process whose results cannot be fully verified by subsequent cannot be fully verified by subsequent inspection and test has not been inspection and test has not been [adequately] [fully] validated and [adequately] [fully] validated and approved according to established approved according to established procedures…………………..procedures…………………..


7.7. 820.20 Management with executive 820.20 Management with executive responsibility has not ensured that an responsibility has not ensured that an adequate and effective quality system adequate and effective quality system has been fully implemented and has been fully implemented and maintained at all levels of the maintained at all levels of the organization……………….organization……………….

8.8. 820.22 Procedures for conducting quality 820.22 Procedures for conducting quality audits were not [estab.] [defined] [doc.] audits were not [estab.] [defined] [doc.] [complete] …........................................[complete] …........................................


9.9. 820.30(i) Procedures were not [est.] [defined] 820.30(i) Procedures were not [est.] [defined] [doc.] …..for the [id.] [doc.] [validation or [doc.] …..for the [id.] [doc.] [validation or verification] [review] [approval] of design verification] [review] [approval] of design changes before their changes before their implementation……………………….implementation……………………….

10.10. 820.30(a) Procedures to control the design 820.30(a) Procedures to control the design process of the devices were not [est.] [defined] process of the devices were not [est.] [defined] [doc.] [complete] [implemented]………………..[doc.] [complete] [implemented]………………..

ENFORCEMENT ISSUE – SUD’sENFORCEMENT ISSUE – SUD’s

Reuse of Single Use Devices (SUD’s)Reuse of Single Use Devices (SUD’s) i.e. reprocessed by third parties and hospitalsi.e. reprocessed by third parties and hospitals All reprocessors have premarket approval All reprocessors have premarket approval

requirements unless exempted by regulation.requirements unless exempted by regulation.

All firms were inspectedAll firms were inspected Significant GMP deficiencies noted for manySignificant GMP deficiencies noted for many Primarily validation and component controlPrimarily validation and component control 17 Warning Letters were issued17 Warning Letters were issued 2 Injunctions were imposed2 Injunctions were imposed www.fda.gov/cdrh/reuse/index.htmlwww.fda.gov/cdrh/reuse/index.html

THE GOODTHE GOOD

THE BADTHE BAD

THE UGLYTHE UGLY

Documents

Device Initiatives FY 2005 Karen A. Coleman FDA Device National Expert