Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of the FDA and Implications for Nanobiotechnology

Authors utilized legal, policy, and ethics resources, both online and in print.

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The scope of this article does not include foods, cosmetics, biologics, and animal drugs.

This pertains to products except that those “for which a license has been approved under subsection (a) shall not be required to have an approved application under section 505 of such Act (21 U.S.C. 355).” 42 U.S.C. § 262(j) (2009).

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21 U.S.C. §§ 351–360 (2009).

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21 C.F.R. § 314 (2009). The FDA provides guidance for the NDA process. See FDA, Good Review Management Principles for PDUFA Products , April 2005, available at <http://www.fda.gov/CDER/GUIDANCE/5812fnl.pdf> (last visited August 20, 2008).

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The medical device provisions allow manufacturers to file an Investigational Device Exemption (IDE) to clinically test experimental devices in order to acquire safety and performance data. This is similar to the IND process, except that approval by a local IRB is typically sufficient unless the process of review by the committee is found to be inadequate. 21 U.S.C. § 360(j)(g) (3)(A)(ii)(II) (2009). The FDA divides investigational devices into two categories: Those posing “significant risk” with requirements similar to new drugs and those that do not pose significant risk where IRB approval and satisfaction of a number of other requirements achieves the IDE status without the rigorous application process. 21 C.F.R. § 812.2(b) (2009).

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