# Presentation: 694491

## An Update on ASRs -- the FDA perspective Steven I. Gutman, MDDirector, Office of In Vitro Diagnostic Device Evaluation and SafetyCenter for Device Evaluation and Radiological HealthFood and Drug Administration

## In-House Laboratory Tests

- Wide variety of tests
- Common practice in laboratories

## In-House Laboratory Tests

- Medical devices
- FDA enforcement discretion
- Recognition of CLIA’s role

## Analyte Specific Reagents (ASRs) Rule

- Rule effective November 24, 1998
- Fueled by history
- Incremental increase in regulation
- Down-classification
- Deliberate effort for safe harbor

## Analyte Specific Reagents

- Antibodies, specific receptor proteins, nucleic acid sequences, and similar biological reagents which through chemical binding or reaction with substances in specimen are intended for identification and quantification of an individual chemical substance or ligand in biological specimens

## ASR: Impact on Manufacturers

- Required to register and list
- Required to meet good manufacturing practices
- Required to report adverse events
- Restricted distribution, use, and labeling

## ASR: Impact on Laboratories

- Restricted to high complexity laboratories
- CLIA requirements
- Report disclaimers

## Labeling of ASRs

- Mandatory language, restricted labeling
- Discretionary explanation

## Exceptions

- Blood bank reagents
- Diagnostics with high risk of contagion and morbidity or mortality – HIV and TB
- Markers for genetic testing

## Regulation of Genetics Tests

- Hot button item
- IOM – 1994
- Task Force on Genetics Tests – 1997
- Secretary’s Advisory Committee on Genetic Tests – 2001
- Regulatory gaps

## CLIA

- Systems oriented
- Analytical performance
- Quality control
- Practice of medicine
- Relatively few but prominent failures

## FDA

- Device specific
- Analytical performance
- Clinical performance
- Failures but rules of engagement

## SACGT

- CLIA role expanded
- CDC post-marketing data gathering
- FDA premarket review

## SACGT

- Risk based approach
- Template based approach
- Avoid chilling technology
- Ensure proper information in place

## HHS Responses

- Action Plan
- CLIA
- CDC
- FDA

## Regulatory Pause

- Internal assessment at FDA
- SACGT replaced by new committee
- Professional group proposals

## Current Status

- Risk based regulation is possible
- Legal
- Good public health policy
- Directed at ASRs

## Work Plan

- Reopen ASR rule
- Rethink basic tenets
- Expand oversight – risked based approach
- Address level playing field arguments

## Work Plan

- Not focused on genetic tests – no exceptionalism
- Risk/review balance under discussion
- Narrow selection
- Broader selection

## Learning with ASR Use

- More complex universe than originally appreciated
- Incentives toward non-standardization
- Lack of clarity in application
- Lack of clarity in reimbursement impact

## Experience with ASR Use

- Regulatory approach
- Incremental change in part practice driven
- Uncompleted projects – visibility for ASRs
- Rule did not make harbor waveless

## Colorful Marketing Continues

- RUO/IUO products
- ASRs inappropriately bundled
- ASRs that are not ASRs but are perhaps ASR like
- All lessons for future use

## FDA Dual Mission	

- Allow rapid access to good new technology
- Prevent bad products from being marketed
- Obvious inherent tension
- Collaborative work toward happy ending

## GOOD SCIENCE