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
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 CertificationDevice Certification
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
Recall Actions FY 2002Recall Actions FY 2002
0
100
200
300
400
500
FY 2002 = 634
Class 1 = 15
Class 2 = 467
Class 3 = 146
Safety Alerts= 6
Recall Actions FY 2003Recall Actions FY 2003
0
100
200
300
400
500
FY 2003 = 608
Class 1 = 7
Class 2 = 460
Class 3 = 141
Safety Alerts= 9
Recall Actions FY 2004Recall Actions FY 2004
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]
ENFORCEMENT ENFORCEMENT INITIATIVESINITIATIVES
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
ENFORCEMENT ENFORCEMENT INITIATIVESINITIATIVES
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 ] ……….……….
GMP / 483 Top TenGMP / 483 Top Ten
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 …..
GMP / 483 Top TenGMP / 483 Top Ten
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…………………..
GMP / 483 Top TenGMP / 483 Top Ten
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] …........................................
GMP / 483 Top TenGMP / 483 Top Ten
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
Top Related