1

2004 Focused Assessment of CDRH Class II Special Controls Guidance Document Program

2

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.

3

2004 Project Purpose

To assess the impact of Special Control Guidance Documents on the 510(k) program.

4

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.

5

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

6

2004 Focused Assessment

1. Review Time Study

2. Industry Survey

3. FDA Reviewer Survey

7

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

11

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

13

2004 Focused Assessment

1. Review Time Study

2. Industry Survey

3. FDA Reviewer Survey

14

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

15

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)

16

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

17

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”.

18

2004 Focused Assessment

1. Review Time Study

2. Industry Survey

3. FDA Reviewer Survey

19

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

21

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%

22

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%

23

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?

0

1

2

3

4

5

6

7

8

9

Nev

er

min

imal

som

etim

es

freq

uent

alw

ays

Sponsor explanation

Consult w ith branchchief

Standards w ebsite

Guidance document

24

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

10

Not

min

imal

ly

som

etim

es

freq

uent

ly

alw

ays

Sponsorexplanation

Consult w ithbranch chief

Standards w ebsite

Guidancedocument