3D extension to MIT-Manus.pptVIP

2004 Focused Assessment of CDRH Class II Special Controls Guidance Document Program 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. 2004 Project Purpose To assess the impact of Special Control Guidance Documents on the 510(k) program. 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. 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 2004 Focused Assessment Review Time Study Industry Survey FDA Reviewer Survey 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 Total Review Time Before vs. After Document Issue Date* Manufacturer Review Time Before vs. After Document Issue Date* 2004 REVIEW TIME ANALYSIS Percent of Applications with 1 Hold 2004 Focused Assessment Review Time Study Industry Survey FDA Reviewer Survey 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 2004 INDUS