Does a physician, in private practice, conducting research with an FDA regulated product, need to obtain IRB approval?

Yes. The FDA regulations require IRB review and approval of regulated clinical investigations, whether or not the study involves institutionalized subjects. FDA has included non-institutionalized subjects because it is inappropriate to apply a double standard for the protection of research subjects based on whether or not they are institutionalized. An investigator may be able to obtain IRB review by submitting the research proposal to a community hospital, a university/medical school, an independent IRB, a local or state government health agency or other organizations. If IRB review cannot be accomplished by one of these means, investigators may contact the FDA for assistance (Health Assessment Policy Staff 301-827-1685).