# Presentation: 728171

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

**May 2003**
**Eric Rechen**
**Program Operations Staff**
**Office of Device Evaluation**

## 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**

## Current Analysis(continued)

**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 3****rd**** party 510(k)s**

**(n = 1,021)**

**(n = 623)**

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

**Days**

***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 3****rd**** party 510(k)s**

**106**

**140**

**(n = 1,021)**

**(n = 623)**

## 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**

## Additional Analysis(continued)

**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 3****rd**** party 510(k)s**

**Traditional 510(k)s**

**Abbreviated 510(k)s**

- (n = 949)

- (n = 603)

- (n = 72)

- (n = 20)

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

**Days**

***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 3****rd**** party 510(k)s**

**106**

**139**

**104**

**159**

**Traditional 510(k)s**

**Abbreviated 510(k)s**

- (n = 949)

- (n = 603)

- (n = 72)

- (n = 20)

## 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**

## Impact of Standards(continued)

**Absent guidance, use of a declaration of conformity to a recognized standard in an abbreviated 510(k) may actually delay 510(k) clearance**

## Impact of Standards(continued)

**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**