# Presentation: 882295

## Office of In Vitro Diagnostic Device Evaluation and Safety

- Donald St.Pierre
- Deputy Director for
- New Device Evaluation
- AdvaMed’s 13th Annual Device Submissions Workshop

## The Story Line

- Organization & Resources
- Workload
- Review Statistics
- MDUFMA

## ORGANIZATION &RESOURCES

## Structure - OIVD

- Single Organizational Unit
- Premarket
- Compliance
- Post-market
- One Stop Shopping
- Delayered – no more branches
- Streamlined – minimal administrative support

## OIVD (con’t)

- Goals
- Increased Transparency
- Uniform Least Burdensome Approach
- Expedited Technology Transfer
- Improve Connectivity and Quality of Work
- Objective - TPLC
- Common Technical Base
- Faster Response Time

## SEE ORGANIZATIONAL CHART

## Thanks to MDUFMA

- Approaching FY01 Staffing Level
- 11th Annual Workshop – 66
- 12th Annual Workshop – 54
- 13th Annual Workshop – 63
- Doug Wood (DCTD - 5/18)
- Cecily Jones (DIHD – 6/1)
- Marieanne Brill (DMD – 6/1)
- 3 more are in-process
- Total Projected --70-75 by EOY

## Parallel to other offices

- ODE
- Same commitments, responsibilities
- Adopt spirit of LB, summaries/balance
- OC
- Same commitments, responsibilities
- Still learning, moving 510(k)s this direction, 30-day notice changes, tracking, MOU
- OSB
- Eggs in MedSun basket
- Move from MDRs to active surveillance

## Other Offices - Projects

- OST
- Software support
- Guidance collaboration
- OHIP
- Still some pt labeling/human factors
- OIVD website
- OSM
- Collaborative software, databases, tracking, eReview

## External Outreach

- IVD Roundtable
- Professional IVD Roundtable
- Pharmacogenomic Roundtable
- Therapeutic Drug Management RT
- Internal Staff College
- NIH/NCI
- CDC/CMS
- SAMHSA

## II.  WORKLOAD

## PMA Receipts (1⁄2 FY03)

| Original PMAs | 2 |
| --- | --- |
| Normal PMA/S | 8 |
| Panel-Track PMA/S | 1 |
| Real-Time PMA/S | 12 |
| 30-day notice | 15 |
| Special PMA/S | 9 |
| PMA Modules | 8 |

## 510(k) Receipts (1⁄2 FY03)

| All 510(k)s | 361 |
| --- | --- |
|     Traditional  | 315 |
|     Abbreviated |  14 |
|     Special |  32 |

## Other OIVD Documents

|  | Pre-IDE
 | Pre-IDE
Supple. | IDE | IDE Supple. |
| --- | --- | --- | --- | --- |
| FY99 |      55 |      10 |      1 |      11  |
| FY00 |      64 |       11 |      3   |       8 |
| FY01 |      85 |       16 |      1 |      10 |
| FY02 |      96 |       33 |      4 |       9 |
| 1⁄2 FY03 | 39 | 15 | 1 | 0 |

## Other Receipts (1⁄2 FY03)

| HDE | 0 |
| --- | --- |
| PDP | 0 |
| 513(g) | 9 |

## Standards Activities

- 5 revised
- 4 withdrawn
- 15 new
- (See 4/28/03 FR notice)

## GHTF

- CDRH active in all Study Groups (SG); OIVD active in SG 1 (POC - Ginette Michaud)
- SG1: operational aspects of medical device regulation including IVD products
- Current IVD harmonization projects:
-  classification
-  labeling
-  IVD premarket conformity with  principles for safety and performance
- STED (?)

## FY03 Guidance Documents

- Multiplex Tests for Heritable DNA Markers, Mutations and Expression Patterns
- Antimicrobial Susceptibility Test (AST) Systems
- Analyte Specific Reagents; Small Entity Compliance Guidance

## Guidances In-the-Works

- Coagulation
- NIOX and 1 other Denovo
- Replacement Reagent
- Glucose
- IVD Device Studies (BiMo)

## OIVD Counter Terrorism Activities

- Established emergency response plans, in conjunction with HHS and FDA, to monitor and respond to a terrorist event
- Expediting the review of device submissions related to counter terrorism and military need
- Evaluating the safety and effectiveness of diagnostic test kits that detect biothreat agents
- Participated in TOPOFF Exercise

## Other Resource Issues

- Classifications – Herpes, B. Anthracis, Yersinia Pestis
- Scorecards
- CBER/CDRH interactions
- CPI
- TPLC/Patient Safety
- SARS/WNV
- ASRs/Genetics
- CLIA/OC

## On the Web FY03

- 510(k) - IDI Strep B for Preg. Women
- 510(k) - pro-BNP for CHF
- 510(k) - Home Glycated Hemoglobin for Diabetics
- 510(k) - Cobalt Albumin to rule out Heart Attack
- 510(k) - Breath test for Asthma
- 510(k) - Aspergillus

## On the Web FY03

- Lab Safety Tips
- Accu Chek class II Recall
- SSED - P020027 (FPSA)
- SSED - P020011 (HCV)
- IVD 510(k) Workshop
- Expanded use for HPV
- Consumer Information

## Ongoing Activities

- Performance Scorecards
- Looking for measurable outcomes (e.g.,)
- Decrease enforcement actions
- Decrease recalls
- Decrease MDRs
- Decrease review times
- Increase decision quality
- Improve BiMo audit results
- Measure feedback

## Ongoing Activities

- New IVD Webpage (good first effort)
- _[www.fda.gov/cdrh/oivd](http://www.fda.gov/cdrh/oivd)_
- Standardizing review format
- Learning about compliance
- Learning about post-market
- MedSun to LabSun
- Post-market safety team

## Post-Market Safety Team - Themes

- Consumer education/outreach
- Internal training (522 authority, STAMP, safety alerts, public health advisories/notifications, MDRs, MedWatch, MedSun)
- Tap Epi group – databases/literature
- Pick a disease and focus
- Active Surveillance ideas

## Review Statistics

## Original PMA Approvals

|  |     # of Decisions | Ave
FDA
Time | Ave
MFG
Time | Ave
Total 
Time |
| --- | --- | --- | --- | --- |
| FY02       OIVD
                 ODE | 7
41 | 221
259 | 45
105 | 266
364 |
| 1⁄2 FY03   OIVD
                 ODE    | 3
14 | 216
261 | 24
143 | 240
404 |

## PMA Supplement Approvals

|  |     # of Decisions | Ave
FDA
Time | Ave
MFG
Time | Ave
Total 
Time |
| --- | --- | --- | --- | --- |
| FY02         OIVD
                  ODE  | 54
532 | 145
96 | 19
28 | 164
124 |
| 1⁄2 FY03     OIVD
                  ODE | 30
270 | 81
83 | 13
31 | 94
114 |

## 1⁄2 FY03 510(k) Review Stats

|  |     n | FDA 
time | MFG time | Total
time |
| --- | --- | --- | --- | --- |
| All 510(k)s        OIVD
                          ODE | 354
2164 | 56
75 | 13
28 | 69
103 |
| Trad.                OIVD 
                          ODE | 312
1643 | 59
86 | 14
33 | 73
119 |
| Abbrev.            OIVD
                          ODE | 10
109 | 48
75 | 11
20 | 59
95 |
| Special            OIVD
                          ODE | 32
412 | 26
28 | 4
8 | 30
36 |

## 510(k) Review Stats

|  | FY02 | 1⁄2 FY03 |
| --- | --- | --- |
| Ave # of cycles                   OIVD
                                            ODE | 1.43
1.40 | 1.31
1.40 |
| Ave # FDA days/cycle        OIVD
                                             ODE | 45
55 | 43
53 |
| Ave # MFG days/cycle       OIVD
                                             ODE | 43
64 | 40
60 |

## CLIA Workload

## IV. MDUFMA

- Participating on implementation teams
- Providing input on Guidances
- Clarifying terminology
- Bundling

## Bundling Principles

- Historically Done – continue
- Not Historically Done – don’t, unless it makes sense & can be reviewed efficiently
- Second thoughts on our part (e.g., HBV)
- Guidance Coming
- No fee for Replacement Reagents

## Challenges for the New Millennium

- CLIA waiver
- Genetic Diseases/ASRs
- Microarrays/High throughput assays
***Turbo ***510(k)
- TPLC
- Integrating all the work of the Center into OIVD