1 2004 focused assessment of cdrh class ii special controls guidance document program
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2004 Focused Assessment of CDRH Class II Special Controls Guidance Document Program
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Special Controls Guidance Documents
Released beginning in 2002 for certain product lines.
Identifies the risks associated with specific device types as well as the Agency’s recommendations for addressing them.
Relies heavily on the use of standards.
=> Aimed at reducing regulatory burden while still ensuring that the risks associated with the device are adequately addressed.
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2004 Project Purpose
To assess the impact of Special Control Guidance Documents on the 510(k) program.
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2004 Action Plan
1. Review background FDA studies regarding the 510(k) review process.
2. Survey both internal and external customers specifically affected by special controls guidance documents.
3. Analyze the impact as related to efficiency, burden, and satisfaction.
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BACKGROUND FDA STUDIES (Prior to 2004)
I. 2001 Analysis of standards usage in 510(k)s
II. 2001 Standards Survey
III. 2003 Impact of guidance and standards on 510(k) review times and cycles
IV. 2003 PCPSR Survey
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2004 Focused Assessment
1. Review Time Study
2. Industry Survey
3. FDA Reviewer Survey
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Review of FDA databases. 19 Class II Special Controls Guidance
Documents issued in the past 2 years. Pre-issue vs. post-issue review times and
application holds. Focus on submissions using 5 documents
with adequate number of pre- and post-issue submissions (>5).
N = 261
2002-2004 REVIEW TIME STUDY: Methods
1. Human Dura Mater
2. Dental Sonography and Jaw Tracking Devices
3. Arrhythmia Detector and Alarm
4. Breast Lesion Documentation System
5. Surgical Sutures
6. Resorbable Calcium Salt Bone Void Filler Device
7. Optical Impression Systems for CAD/CAM of Dental Restorations
8. Knee Joint Metal/Polymer Porous-Coated Uncemented Prostheses
9. Cutaneous Carbon Dioxide (PcCo2) and Oxygen (PcO2) Monitors
10. Intraoral Devices for Snoring and/or Obstructive Sleep Apnea
11. Transcutaneous Air Conduction Hearing Aid System (TACHAS)
12. Polymethylmethacrylate (PMMA) Bone Cement
13. Apnea Monitors
14. Hip Joint Metal/Polymer Constrained Prosthesis
15. Endolymphatic Shunt Tube with Valve
16. Endotoxin Assay
17. Antimicrobial Susceptibility Test (AST) Systems
18. Serological Reagents for the Diagnosis of West Nile Virus
19. Breath Nitric Oxide Test System
Class II Special Controls Guidance Documents
Total Review Time Before vs. After Document Issue Date*
0
50
100
150
200
250
Arrhythmia Sutures Bone Filler Apnea Bone Cement
BeforeAfter
Guidance Document
Tota
l D
ays
2004 Average Review Time
* Includes draft issue
19 16 59 16 37 15 11 12 1016 = n
0
50
100
150
200
250
Sutures Bone Filler Apnea Bone Cement
BeforeAfter
Guidance Document
Man
ufa
ctu
rer
Days
* Includes draft issue
Manufacturer Review Time Before vs. After Document Issue Date*
2004 Average Review Time
59 16 37 15 11 12 1016 = n
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2004 REVIEW TIME ANALYSIS
Total review time(days)
Manufacturer review time
(days)
Pre Post p Pre Post p
Sutures
122 110 ns 78 75 ns
BoneFiller
176 123 0.04 50 32 ns
Apnea 182 135 ns 83 29 ns
BoneCement
307 209 ns 147 53 ns
Arrhythmia
149 125 0.03 28 33 ns
0
10
20
30
40
50
Arrhythmia Sutures Bone Filler Apnea Bone Cement
BeforeAfter
Guidance Document
Perc
en
t
Percent of Applications with >1 Hold
2004 Impact of Guidance Documents on Hold Number
19 16 59 16 37 15 11 12 1016 = n
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2004 Focused Assessment
1. Review Time Study
2. Industry Survey
3. FDA Reviewer Survey
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2004 INDUSTRY SURVEY: Methods
Convenience sample Telephone “cold calls” Survey domains
Company demographics Familiarity with and use of guidance
documents with standards Using Likert scale rate changes in:
Review time Documentation burden Overall satisfaction
Comments for improvement
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2004 INDUSTRY SURVEY: Results
18 respondents (out of 50 manufacturers) 6 – Bone cement (of 9) 5 - Arrhythmia detectors (of 25) 4 – Bone void filler (of 36) 3 – Sleep apnea/snoring (of 16)
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1 2 3 4 5
Improvedefficiency
Reducedburden
Improvedsatisfaction
2004 INDUSTRY SURVEY: Scores
Likert rating scale - 1 = disagree strongly, 2 = disagree somewhat, 3 = neutral, 4 = agree somewhat, 5 = agree strongly
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2004 Comments for Improvement
“Update guidance documents on a regular basis.”
“Have pre-submission conference calls or meetings.”
“Respond to comments and suggestions from industry.”
“Verbal communication with the FDA is key. They need to tell us when to use and where to find the documents and standards”.
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2004 Focused Assessment
1. Review Time Study
2. Industry Survey
3. FDA Reviewer Survey
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2004 FDA Reviewer Survey: Methods
Web-based survey (Zoomerang) FDA reviewers targeted through
Division branch chiefs based on product line.
Confidential 12 questions:
5 multiple choice per product line 2 open-ended 2 rating (Likert scale)
1. Human Dura Mater
2. Dental Sonography and Jaw Tracking Devices
3. Arrhythmia Detector and Alarm
4. Breast Lesion Documentation System
5. Surgical Sutures
6. Resorbable Calcium Salt Bone Void Filler Device
7. Optical Impression Systems for CAD/CAM of Dental Restorations
8. Knee Joint Metal/Polymer Porous-Coated Uncemented Prostheses
9. Cutaneous Carbon Dioxide (PcCo2) and Oxygen (PcO2) Monitors
10. Intraoral Devices for Snoring and/or Obstructive Sleep Apnea
11. Transcutaneous Air Conduction Hearing Aid System (TACHAS)
12. Polymethylmethacrylate (PMMA) Bone Cement
13. Apnea Monitors
14. Hip Joint Metal/Polymer Constrained Prosthesis
15. Endolymphatic Shunt Tube with Valve
16. Endotoxin Assay
17. Antimicrobial Susceptibility Test (AST) Systems
18. Serological Reagents for the Diagnosis of West Nile Virus
19. Breath Nitric Oxide Test System
Class II Special Controls Guidance Documents
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2004 FDA Reviewer Survey: Response rate
Total visits to online survey
Partially completed surveys
Fully completed surveys
42 16 19 Reviewer experience (in mean years) for all respondents
Average number of respondents per device
Average number of submissions reviewed per device
8.75 1.57
1-10 = 44%11-25 = 33%>25 = 23%
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2004 FDA Reviewer Survey: Results
Respondents refer to Class II special control guidances during their reviews for the following reasons:
To insure review consistency 41%
As a training tool or for background information 74%
To identify relevant FDA recognized consensus standards100%
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2004 FDA Reviewer Survey: Results
QUESTION:When encountering a standard that has been cited in a submission, what resources do you use for determining the applicability of the standard to the proposed device?
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Nev
er
min
imal
som
etim
es
freq
uent
alw
ays
Sponsor explanation
Consult w ith branchchief
Standards w ebsite
Guidance document
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2004 FDA Reviewer Survey: Results
QUESTION:When encountering a standard that has been cited in a submission, how effective are the following resources for determining the applicability of the standard to the proposed device?
0123456789
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Not
min
imal
ly
som
etim
es
freq
uent
ly
alw
ays
Sponsorexplanation
Consult w ithbranch chief
Standards w ebsite
Guidancedocument