# Presentation: 368333

## Humanitarian Device Exemptions (HDE) and IDE Programs

**Elizabeth Mansfield**
**OIVD/CDRH**
**Food and Drug Administration**

## Section 520(m) of the FD&C Act

**  “... ****to encourage the discovery and use of devices intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect fewer than 4,000 individuals in the United States”**

## Statutory Conditions

**Device would not otherwise be available**
**No comparable device**
**Device does not expose pts to unreasonable risk of illness or injury**
**Probable benefit outweighs the risk**

## Statutory Conditions(Cont’d)

**Device must be used with IRB review and approval**
**Amount charged cannot exceed research, development, manu-**
**  ****facturing, and distribution costs**

## HDE Application (2 Parts)

_**Part 1**_** - ****Request for HUD Designation:**
**Description of pt population/IFU**
**Device description**
**Documentation to support 4,000 pts in US per year**
**45 day review (approve, disapprove, request additional information)**

## HDE Application (2 Parts)

_**Part 2**_** - HDE Application (ODE):**
**HUD designation**
**Explanation why device not otherwise available**
**Statement that no other comparable device exists**
**HUD labeling**
**Amount charged/verifying report**

## HDE Application (2 Parts)

_**Part 2**_** - HDE Application:**
**Device  description**
**Pre-clinical testing**
**Clinical experience**
**Manufacturing information**
**Labeling (physician and patient)**

## Marketing Approval

**  ****Device does not expose patients to **_**unreasonable**_** risk of illness or injury and **_**probable**_** benefit outweighs the risk of using the device, taking into account the probable risks and benefits of **_**alternative**_** therapies**

## Examples of HDE Approvals

**Fetal bladder stents**
**Heart valve**
**Gastric stimulator**
**“****Artificial skin”**
**Hip prosthesis with antibiotic bone cement**
**Ecarin clotting time kit**

## Issues to Consider

**Is 4,000 the right limit? For both therapeutics and diagnostics?**
**Are the postmarket requirements (e.g., IRB approval, cost containment) appropriate?**
**Why are so few HDEs submitted to FDA?  Would reimbursement help?**

## Investigational Device (IDE) Exemption (21 CFR Part 812)

**“...****to encourage...the discovery and development of useful devices intended for human use, and to that end to maintain optimum freedom for scientific investigators in their pursuit of this purpose.”**

## IDE 2

**  “****An approved IDE permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device.”**

## When is an IDE required?

**Investigation of a device that has significant risk of injury**
**Intended as an implant**
**Supports or sustains human life**

## When is an IDE required?

**Is of substantial importance for in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health ****	****	****	**
***	******	******	******	******and***** **
**presents a potential risk to health, safety, or welfare of a subject**

## IDE Requirements

**   **
**Clinical ***investigations*** of devices to**
**	****determine safety and effectiveness**
**adhere to labeling requirements, **
**have IRB approval, **
**have informed consent, **
**be properly monitored, **
**records properly maintained,  **
**not promote (market, charge, represent as safe and effective, etc.)**
**	****	****	**

## Labeling of IDEs

**CAUTION—Investigational device.  Limited by Federal law to investigational use**

## IDE Process

**Similar to PMA**
**Must contain investigational plan**
**Report on prior clinical, animal or laboratory investigations, if any**

## Treatment under IDE(Treatment IDE)

**No other alternative treatment available**
**Immediately life-threatening disease**
**Under clinical trial for same use**
**Sponsor is pursuing marketing approval/clearance **

## IDE Applications

**Uncommon for IVDs**
**May be disapproved**
**May be changed with prior approval**
**Not a mechanism for marketing a device without FDA review**