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

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 • Review background FDA studies regarding the 510(k) review process. • Survey both internal and external customers specifically affected by special controls guidance documents. • 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 • Review Time Study • Industry Survey • FDA Reviewer Survey

7. 2002-2004 REVIEW TIME STUDY: Methods • 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

8. Class II Special Controls Guidance Documents • Human Dura Mater • Dental Sonography and Jaw Tracking Devices • Arrhythmia Detector and Alarm • Breast Lesion Documentation System • Surgical Sutures • Resorbable Calcium Salt Bone Void Filler Device • Optical Impression Systems for CAD/CAM of Dental Restorations • Knee Joint Metal/Polymer Porous-Coated Uncemented Prostheses • Cutaneous Carbon Dioxide (PcCo2) and Oxygen (PcO2) Monitors • Intraoral Devices for Snoring and/or Obstructive Sleep Apnea • Transcutaneous Air Conduction Hearing Aid System (TACHAS) • Polymethylmethacrylate (PMMA) Bone Cement • Apnea Monitors • Hip Joint Metal/Polymer Constrained Prosthesis • Endolymphatic Shunt Tube with Valve • Endotoxin Assay • Antimicrobial Susceptibility Test (AST) Systems • Serological Reagents for the Diagnosis of West Nile Virus • Breath Nitric Oxide Test System

9. 2004 Average Review Time 19 16 59 16 37 15 16 11 12 10 = n Total Review Time Before vs. After Document Issue Date* Total Days Guidance Document * Includes draft issue

10. 2004 Average Review Time 59 16 37 15 16 11 12 10 = n Manufacturer Review Time Before vs. After Document Issue Date* Manufacturer Days Guidance Document * Includes draft issue

11. 2004 REVIEW TIME ANALYSIS

12. 19 16 59 16 37 15 16 11 12 10 = n 2004 Impact of Guidance Documents on Hold Number Percent of Applications with >1 Hold Percent Guidance Document

13. 2004 Focused Assessment • Review Time Study • Industry Survey • 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. 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 • Review Time Study • Industry Survey • 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)

20. Class II Special Controls Guidance Documents • Human Dura Mater • Dental Sonography and Jaw Tracking Devices • Arrhythmia Detector and Alarm • Breast Lesion Documentation System • Surgical Sutures • Resorbable Calcium Salt Bone Void Filler Device • Optical Impression Systems for CAD/CAM of Dental Restorations • Knee Joint Metal/Polymer Porous-Coated Uncemented Prostheses • Cutaneous Carbon Dioxide (PcCo2) and Oxygen (PcO2) Monitors • Intraoral Devices for Snoring and/or Obstructive Sleep Apnea • Transcutaneous Air Conduction Hearing Aid System (TACHAS) • Polymethylmethacrylate (PMMA) Bone Cement • Apnea Monitors • Hip Joint Metal/Polymer Constrained Prosthesis • Endolymphatic Shunt Tube with Valve • Endotoxin Assay • Antimicrobial Susceptibility Test (AST) Systems • Serological Reagents for the Diagnosis of West Nile Virus • Breath Nitric Oxide Test System

21. 2004 FDA Reviewer Survey: Response rate 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 standards 100%

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?

24. 2004FDA 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?