# Presentation: 320555

## Center for Devices and Radiological Health (CDRH)

- Device Issues
- Non-Significant Risk Studies
- Custom Devices
- Humanitarian Use Devices
- In Vitro Diagnostic Devices

## Non-Significant Risk Device Study

- Regulation:  21 CFR 812.66
- Guidance:  FDA Information Sheets
- Sponsors will necessarily make the NSR decision when developing their research plan for a device
- IRBs must review each NSR device research study and determine whether it is a NSR or SR
- FDA is available to help and its determination is final

## NSR Device Study

- IRB Responsibilities
- Follow written procedures that describe how Board will make the SR/NSR determination 	21 CFR 108 (a)
- Record determination in meeting minutes... 	21 CFR 56.115 (a)
- Report to investigator and where appropriate the sponsor
- 21 CFR 108 (a)

## NSR Device Study

- Inspectional technique
- Ask IRB for list of NSR device studies
- Copy the list, including protocol title, sponsor, clinical investigator, etc.
- Attach as an exhibit to the EIR
- Review meeting minutes of the NSR studies and determine if IRB followed procedures and regulations

## 	Custom Device  

**  ****Federal Food, Drug, and Cosmetic Act, Sec. 520(b)**
**  ****Code of Federal Regulations**
**21 CFR 812.3 (b)**

## The ActSection 520 (b)

- Sec. 514 (standards), and 515 (class III) do not apply to any device which, in order to comply with the order of an individual physician or dentist, necessarily deviates from an otherwise applicable performance standard or requirement  prescribed at section 515 if:
- 1) the device is not generally available in finished form and not offered through labeling or advertising by the manufacturer for commercial distribution.

## The ActSection 520 (b)

- 2) the device is intended for use by an individual patient named in the order by the physician and is to be made in a specific form for the patient, or
- It is intended to meet the special needs of such physician or dentist, and
- It is not generally available to or generally used by other physicians.

## Regulations 21 CFR 812.3Definition of Custom DeviceRepeats info in the act

- Necessarily deviates from devices generally available
- Not generally available to physicians
- Not generally available for purchase
- Not offered for commercial distribution

## 21CFR 812.3Custom Device

- Is intended for use by an individual patient named in the order of a physician or dentist, or is made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice

## Example of Custom Device

- External pacemaker needed for a fetus
- Lead is only made as single lumen, 6 Fr.
- Physician approached the manufacturer to design and make a double lumen,  size 3 French, for use in a fetus.
- The manufacturer had to construct this device.
- Used for one unique situation for one specific subject

## 3 Examples when a device is not a Custom Device

- Hydrocephalic shunts made of some other material than silicone because patients allergic to silicone. (IDE needed)
- Cranial helmets for miss-shaped new- born heads.  The helmets are shaped or sized i.e. “fitted” for each subject. (IDE needed)
- Thoracic Aortic Aneurysm graft ordered individually for each patient (IDE needed)

## Custom Device Issues

- Must not be used to circumvent the regs
- State of the art – new technology device
- Used for unique medical anomaly
- One subject use
- No data collected.  It is not research.
- After Custom use, if there is interest to pursue research, then IDE necessary.
- Custom device may be class 2 or 3.

## Inspectional Technique

- Sponsor site:  ask if the sponsor has filled any requests to make a custom device.
- Investigator site:  ask if the investigator has used a custom device.
- IRB:  ask the IRB if it has had the occasion to review requests to use custom device. Review is not required by regulations, but an investigator may have approached the IRB

## Humanitarian Use DeviceHUD

- Regulation:  21 CFR 814 Subpart H – Humanitarian Device Exemption (HDE)
- Reporting adverse events: 21 CFR 803 Medical Device Reports
- Guidance: Http//:www.fda/gov/cdrh/ode/hdeinfo.html

## Definition of HUD

- Device intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect fewer than 4,000 individuals in the U.S.
- The device would not be available except through HUD
- Probable benefit outweighs the risk

## Humanitarian Use Device

- IRB responsibilities  814.124
- Initial review at a convened meeting
- Continuing review
- IRB reports the withdrawal of approval to the sponsor
- Clinical Investigator responsibilities (814.126)
- Report Adverse Events on MDR (ref: 21CFR 803)
- Report Adverse Events to IRB

## HUD Guidance

- Addresses sponsor and IRB issues
- IRB issues
- if appropriate, continuing review may be done by expedited review.
- Informed consent:  Although neither the act nor the regulation requires informed consent, the IRB, institution, or state may require one
- Guidance is under consideration for revision because of the following issues:
- Question 18: appears to limit practice of medicine
- Question 23: inappropriately included emergency use
- Question 24: inappropriately included compassionate use
- AND no guidance on MDR reporting

## Recent HUD Compliance Issue

- Practice of medicine
- TheraSphere HUD
- DBM sent IRBs an educational letter – MDR reporting and research of new uses require an IDE
-  Federal Food, Drug and Cosmetic Act Sec. 906
- Nothing in this Act shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.

## HUD Issues

- Sponsors and investigators cannot promote the off label use of an HUD
- Any research, i.e., collection of safety or effectiveness data of the HUD for uses **not** described in labeling must have an IDE.
- Investigators must report AEs on MDR
- Sponsors required to submit reports to FDA

## In Vitro Diagnostic Studies 

- Office of In Vitro Diagnostics, CDRH
- IRB review is necessary
- Informed consent is necessary
- When stored samples are used the sponsor should call OIVD for advice