In Vitro Diagnostic medical devices (IVDs) have long occupied a poorly understood sector of clinical trials. Now, a recent FDA document, Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies- Frequently Asked Questions (June 25, 2010) clears up many questions. The FAQ offers resources including the definition of many basic IVD and medical device terms. Examples include the FDA definition of the difference between Invasive and Non-Invasive and the difference between a Significant Risk and Non-Significant medical device. The FAQ gives FDA contact information for IVD review divisions and the conduct of clinical trials. Most importantly, the FAQ discusses how IVDs meet the criteria for exemption from most requirements under medical device clinical trial regulations.
The FAQ discusses the requirements for the emergency use of investigational IVDs. It also discusses the differences in informed consent requirements between FDA and the U.S. Department of Health and Human Services which funds NIH studies. Frequently researchers think that if a study is exempt under DHHS regulations (Title 45 Part 46) that the study is exempt from FDA informed consent regulations found in 21 CFR Parts 50 and 56. FDA requires IRB and informed consent even if studies are exempt from most requirements of 21 Part 812.
The FAQ also discusses use of data collected from studies conducted outside the United States. The FAQ gives the following guidance:
“… the PMA regulation, 21 CFR Part 814, allows foreign data to be used as the sole support of a marketing application but only if (1) the data are applicable to the U.S. population and to U.S. medical practices, including laboratory practices, (2) the studies have been performed by clinical investigators of recognized competence, and (3) the data may be considered valid without the need for an on-site FDA inspection or, if necessary, FDA can validate the data through an on-site inspection or other appropriate means (21 CFR 814.15(d)).
For IVD devices, FDA would consider differences in population demographics, disease prevalence, disease presentation, laboratory practices, and medical standards of care. If the sponsor plans to submit an application based solely on foreign data, FDA recommends that the sponsor consult with the reviewing division prior to submission of the application.“The FAQ endorses ICH E6: Consolidated Guidance on Good Clinical Practice as a sound guidance document with sections applicable to medical devices as well as pharmaceuticals. It also discusses the draft ISO 14155 document:
“Although the ICH document was written for studies of pharmaceuticals, sections of the guidance address study issues common to all investigational products. Thus, these sections of the ICH GCP provide a useful reference regarding the proper conduct of studies.
The draft ISO document specifically states that it does not apply to IVD devices. The draft ISO document is an international document intended to reflect basic practices appropriate to clinical trials worldwide. It does not include all of FDA’s specific requirements for clinical studies and is not presently a standard that FDA has officially recognized; therefore, we do not recommend that you rely on it.“The FAQ has two charts, Appendix 1 and Appendix 2, that clear up decision making for IVD exeption criteria as well as informed consent requirements. And in keeping with current FDA clinical trial policy the FAQ emphasizes the use of quality systems for IVDs. The FAQ and two other relevant FDA guidance documents are below:
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