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1 2004 Focused Assessment of CDRH Class II Special Controls Guidance Document Program.

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Presentation on theme: "1 2004 Focused Assessment of CDRH Class II Special Controls Guidance Document Program."— Presentation transcript:

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

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

4 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 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 Focused Assessment 1.Review Time Study 2.Industry Survey 3.FDA Reviewer Survey

7 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 = REVIEW TIME STUDY: Methods

8 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

9 Total Review Time Before vs. After Document Issue Date* Guidance Document Total Days 2004 Average Review Time * Includes draft issue = n

10 Guidance Document Manufacturer Days * Includes draft issue Manufacturer Review Time Before vs. After Document Issue Date* 2004 Average Review Time = n

11 REVIEW TIME ANALYSIS Total review time (days) Manufacturer review time (days) PrePostpPrePostp Sutures122110ns7875ns Bone Filler ns Apnea182135ns8329ns Bone Cement ns14753ns Arrhyth mia ns

12 Guidance Document Percent Percent of Applications with >1 Hold 2004 Impact of Guidance Documents on Hold Number = n

13 Focused Assessment 1.Review Time Study 2.Industry Survey 3.FDA Reviewer Survey

14 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 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 INDUSTRY SURVEY: Scores Likert rating scale - 1 = disagree strongly, 2 = disagree somewhat, 3 = neutral, 4 = agree somewhat, 5 = agree strongly

17 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 Focused Assessment 1.Review Time Study 2.Industry Survey 3.FDA Reviewer Survey

19 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 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 FDA Reviewer Survey: Response rate 1-10 = 44% 11-25= 33% >25= 23%

22 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 information74% To identify relevant FDA recognized consensus standards100%

23 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 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?


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