# Presentation: 747121

## BIORESEARCH MONITORING&IN VITRO DIAGNOSTIC DEVICES

**Presented by**
**Jean Toth-Allen, Ph.D.**
**Biophysicist/Consumer Safety Officer**
**Division of Bioresearch Monitoring**

## Branch Responsibilities

***Program Enforcement Branch I (PEB I)***
- 		  (301) 594-4720
- Responsible for neurological, cardiovascular,
- respiratory, urological, reproductive,
- gastroenterology, renal & radiological devices
***    ******Program Enforcement Branch II (PEB II)***
- 		  (301) 594-4723
- Responsible for general surgery/hospital,
- restorative, orthopedic, ophthalmic, dental, ear,
- nose, & throat, & **in-vitro diagnostic devices**

## Program

**A comprehensive program of on-site**
**inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research.**

## Objectives

**to ensure the quality and integrity of data and information supporting premarket submissions and applications (PMAs, PDPs, IDEs, and 510(k)s)**** **
**to ensure that human subjects taking part in investigations are protected from undue hazard and risk**

## Responsibilities

- Bioresearch Monitoring
- Application Integrity Policy (AIP)
- Promotion & advertising of investigational devices

## Inspections & Audits

**Division of Bioresearch Monitoring ****(DBM or BIMO)**
**Office of In Vitro Diagnostic Devices Evaluation & Safety (OIVD)**
**Field (ORA)**
**Others, as applicable**

_**Team Approach**_

## Inspections and Audits

**Clinical Investigators**
**Sponsors**
**Institutional Review Boards (IRBs)**

_**Who**_

## 21 CFR Regulations

**Part 809 – In Vitro Diagnostic Products for Human Use**
**Part 812 – Investigational Device Exemptions**
**Part 50 –Protection of Human Subjects**
**Part 56 – Institutional Review Boards**

## 21 CFR Part 812

- Significant risk studies
- Non-significant risk studies
- Exempt studies

## Exempt Studies

-   **labeled according to 21 CFR 809.10**
**	****noninvasive**
**	****noninvasive sampling or no significant risk**
**  ****does not introduce energy into a subject**
**	****not used as the diagnostic for ****    determination of treatment**

**21 CFR 812.2(c(3)**

## Significant Risk Determination

**If study involves invasive sampling****	****	**
**If results from use of an investigational IVD will determine treatment, could inaccurate results:**** **
**	****be life-threatening**
**	****result in permanent functional impairment**
**	****result in permanent structural damage**
**	****necessitate medical or surgical intervention****    to prevent impairment or damage**

## Human Subject Protection

**21 CFR Parts 50 & 56 apply to **_***all***_** studies with human subjects**
** ****IRB must review **_***all***_** ****studies**
** ****Expedited review possible**
** ****Informed consent**
**	****protects subject privacy & confidentiality**
**	****facilitates FDA data audits**

## 21 CFR Part 58 ??

**Good Laboratory Practice for ****Nonclinical ****Laboratory Studies **
**to assure quality & integrity of ****safety**** data**
**not applicable to studies with IVD devices – tests regarding safety are clinical studies**

## Compliance Programs

- CP 7348.809 – Institutional Review  Boards
- CP 7348.810 – Sponsors, Contract Research Organizations, and Monitors
- CP 7438.811 – Clinical Investigators

## Compliance Programs

- http://www.fda.gov/ora/compliance_ref/bimo/default.htm

## CDRH BIMO Web Site

- http://www.fda.gov/cdrh/
- 	   comp/bimo.html