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Impact of Guidance and Standards on 510(k) Review Times and Cycles
May 2003

Eric Rechen
Program Operations Staff
Office of Device Evaluation

[PowerPoint version]

Topics

• Background
• Impact of guidance
• Impact of standards
• Conclusions

Background

• March 2001: Expansion pilot added 460 Class II devices without device-specific guidance to 510(k) third party review program
• Program already included:
  • 154 Class II devices with guidance
  • All (57) non-exempt Class I devices

Background(continued)

• Subsequent analysis of “third party” 510(k)s revealed that submissions for devices without guidance had:
  • Higher first-cycle deficiency rates
  • Longer review times
• Same finding for comparable 510(k)s reviewed entirely by CDRH
• Findings based on approx. 60 procodes

Current Analysis

• Intended to determine if previous findings are more generally applicable
• Obtained data on all 510(k)s found SE during FY 02 for Class II devices eligible for third party review
  • Approximately 617 classification regs.
  • 1,644 traditional or abbreviated 510(k)s
• Excluded:
  • “Special” 510(k)s
  • 510(k)s actually reviewed by third parties

Percent of 510(k)s Found Deficient on First Cycle*
-- For Devices With and Without Guidance --

*Based on all 510(k)s (1,644) with SE decisions during FY 2002 that were for Class II devices eligible for third party review, excluding special and 3rd party 510(k)s

Comparison of 510(k) Avg. Review Times
for Devices With and Without Guidance*

*Based on all 510(k)s (1,644) with SE decisions during FY 2002 that were for Class II devices eligible for third party review, excluding special and 3rd party 510(k)s<

Impact of Guidance

• Results similar to previous analysis
• Suggest that CDRH device-specific guidance documents help to:
  • Reduce occurrence of multiple 510(k) review cycles
  • Expedite 510(k) clearance
• May yield ~25 percent reduction

Additional Analysis

• ODE’s FY 2000 Annual Report lists 23 new device-specific guidance docs.
• 9 were 510(k)-related, first-time issuances
• Compared 510(k) first-cycle deficiency rates for FY 98-99 receipts vs. FY 01-02 receipts for these devices
• Excluded “special” and “third party” 510(k)s
• 6 of 9 devices had 510(k) activity during both periods
• Change in first-cycle deficiency rate
  Decrease: 2 devices
  No change: 4 devices
  Increase: 0 devices
• Overall rate: 64% -->53%
  (6 devices)

Additional Analysis (continued)

• Findings are consistent with other analysis and support a causal relationship

What About Standards?

• Analysis of abbreviated 510(k)s may shed some light on the impact of standards

Abbreviated 510(k)

• May only be submitted when an applicant explicitly conforms to:
  • Recognized consensus standard, or
  • Device-specific guidance
    (either “special controls” or other)

Percent of Traditional & Abbreviated 510(k)s
Found Deficient on First Cycle*
-- For Devices With and Without Guidance --

*Based on all 510(k)s (1,644) with SE decisions during FY 2002 that were for Class II devices eligible for third party review, excluding special and 3rd party 510(k)s

Traditional & Abbreviated 510(k) Avg. Review
Times for Devices With and Without Guidance*

*Based on all 510(k)s (1,644) with SE decisions during FY 2002 that were for Class II devices eligible for third party review, excluding special and 3rd party 510(k)s

Impact of Standards

• If guidance exists, explicit conformity with the guidance or with a recognized standard in an abbreviated 510(k) may further expedite clearance
• Absent guidance, use of a declaration of conformity to a recognized standard in an abbreviated 510(k) may actually delay 510(k) clearance
• Why?
  • “Square peg in a round hole”
    i.e., perhaps guidance is needed to clarify how conformity with a recognized standard addresses 510(k) requirements

Conclusions

• Device-specific guidance may significantly improve 510(k) timeliness
• Combined use of recognized standards with guidance may further enhance timeliness
• Use of recognized standards alone may not improve timeliness

Back to Strategic Planning Page

Updated April 26, 2004

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