Some circumstances represent atypical issues/problems not well covered by general policies/procedures. Frequently, these ‘out of the ordinary’ situations may be addressed via further specific regulations.
A medical device is defined, in part, as any health care product that does not achieve its primary intended purposes by chemical action or by being metabolized.
A medical device may not be shipped inter-state unless it is cleared for marketing by the Center for Devices and Radiologic Health (CDRH) of the FDA. If it is not cleared for marketing, the device may not cross-state lines unless it has an exemption called an Investigational Device Exemption (IDE).
An investigational device is a medical device that is the subject of a clinical study designed to evaluate the effectiveness, and/or safety of the device.
Unless exempt from the IDE regulations an investigational device must be categorized as either "significant risk" (SR) or "non-significant risk" (NSR). The sponsor initially makes the determination that a device presents a NSR or SR. The proposed study is then submitted either to FDA (for SR studies) or to the IRB (for NSR studies).
The IRB’s decision to approve or not approve the study will be made after the IRB’s SR/NSR risk determination is made. The IRB may agree or disagree with the sponsor’s initial NSR assessment.
This IRB requests an appendix to the protocol with an explanation of why the device study presents a non-significant risk and any other supporting information. This IRB will consider:
a. The risks of the device as it is to be used in the study situation and not on the device alone.
b. The device's risks will be contrasted with the risks of any marketed device that the subjects would receive were they not to be enrolled in the study.
If the IRB decides the study is Significant Risk:
- Notify sponsor and investigator of SR decision
After IDE obtained by sponsor, proceed to review study applying requisite criteria
21 CFR 56.111& 45 CFR 46.111
- Submit IDE to FDA, or , if electing not to proceed with study, notify FDA of the SR determination
- Study may not begin until FDA approves IDE and IRB approves the study.
- Sponsor and investigator(s) must comply with IDE regulations
If IRB decides the study is Non-Significant Risk:
b. IRB proceeds to review study applying requisite criteria
21 CFR 56.111& 45 CFR 46.111
c. If study is approved by the IRB, the sponsor and investigator must comply with "abbreviated IDE requirements"
21 CFR 812.2
FDA Information Sheets 1998 Update
21 CFR 812.1- 812.19
2. Single Patient Use
Another mechanism through which investigational agents can be obtained for treatment outside of a controlled clinical trial is commonly referred to as "single patient use". Patients who are not eligible for a protocol cannot be enrolled in it. Their physician may, however, be convinced that the drug is useful and should be tried despite the fact that it is not marketed and that there is incomplete safety and efficacy data. Such cases present a therapeutic use of an investigational drug.
Patients who might be helped by a drug in Phase II or III trials but who are not eligible to participate in any such trial may be able to receive a Special Exception from the FDA or National Cancer Institute (NCI).
21 CFR 312.34
3. Marketed Product Usage
a. "Off-Label" Use
If a physician uses a product for an indication not in the approved labeling, he/she has the responsibility to be well informed about the product. Use of a marketed product in this manner when the intent is the "practice of medicine" does not require the submission of an IND, IDE or review by the IRB.
b. Investigational Use
"Investigational use" implies study of a question and involvement of a study protocol and therefore human subjects. All clinical investigations must be IRB approved. FDA policy requires an IND in most circumstances.4. Study Participant Hospitalized At NGHS: Study Being Conducted Elsewhere
The only time this could become an issue is when an individual participating in an investigational study outside of NGHS is hospitalized within NGHS. Prior to continuing the investigational agent, the NGHS physician should:
- Immediately notify an NGHS pharmacist.
- Seek immediate contact with the investigator to obtain information about the test agent
- Seek to obtain a copy of the consent form and, if possible, the IRB approval.