The February 11, 2011 FDA Warning Letter to Anelux brought the need for Investigational Device Exemption (IDE) compliance to the forefront. The medical device field is unique in that product development can occur organically, in the clinical setting and outside of the laboratory or R&D facility. Many of our clients in the orthopaedic, cardiac, and urology fields find new product development ideas directly from practicing physicians or nurse practitioners. These devices — developed in the field — are regulated by the FDA. Once the design has progress from idea to prototype, the next tempting step for the health care practitioner is to test the device to determine if it works as they envisioned.
What many of our medical device company clients do not realize is that such “investigations” by the medical professional on new devices are regulated by the FDA. The failure of either party to recognize this unusual area of regulation can be devastating-sometimes killing an asset purchase deal or lowering a licensee fee. If a medical professional fails to follow FDA requirements in testing field developed devices a company may not want to purchase the product or license the design due to potential compliance liabilities.
The FDA regulates all investigations or research that involve one or more human subjects to determine either safety or effectiveness of the medical device (21 C.F.R. § 812.3(h)). Investigational devices include new and previously untested devices, in addition to modifications to legally marketed medical devices. The FDA’s requirements for investigational devices serve to protect human subjects, as described in 21 C.F.R. Part 50.
Clinical evaluations of an investigational device must have an Investigational Device Exemption (IDE) in place before initiation of the study (21 C.F.R. Part 812). An IDE can be obtained directly from an Institutional Review board (IRB) for non-significant risk devices, but significant risk devices must also have FDA approval. Conducting an investigation under an IDE requires, among other things, informed consent from all patients, labeling for investigational use only, monitoring of the study, and maintenance and submission of required records and reports.
So it begs the question: Are there exemptions to the FDA’s requirements for obtaining an IDE? Yes, an IDE is not required if the device is intended solely for veterinary use or will be used only for research on laboratory animals. Certain diagnostic devices do not require an IDE if the device is noninvasive, does not require invasive sampling, does not introduce energy into the patient, and is not used alone (without confirmation) for diagnosis.
Finally, “custom devices” are exempt from the IDE requirements. A “custom device” is not generally available to, or generally used by, other physicians or dentists; is not generally available in finished form for purchase or for dispensing upon prescription; is not offered for commercial distribution through labeling or advertising; and is intended for use by an individual patient named in the order of a physician or dentist, and is to be 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.
There is a fine line between a medical professional making use of a custom device and investigating a new device that may later be commercialized. Both the device innovator in the field and the company seeking to acquire the technology should be aware of the research requirements and seek to ensure compliance from the beginning.