3.1 The Statutory Standard for Safety and Effectiveness
Under section 513(a) of the Federal Food, Drug & Cosmetic Act (the “FD&C Act”), FDA determines whether PMA applications provide a “reasonable assurance of safety and effectiveness” by “weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use,” among other relevant factors.1 To aid in this process, PMA applicants submit valid scientific evidence, including one or more clinical investigations where appropriate, which FDA reviews to determine whether “the device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling of the device.”2 FDA staff review the data submitted as part of the PMA application and determine – based on a number of factors – if the data support the claims made by the sponsor concerning clinically significant results from the device, i.e., intended use and indications for use, and if the data analysis demonstrates that the probable3 benefits of the device outweigh its probable risks. A balanced consideration of probable benefits and probable risks is an essential part of FDA’s determination that there are reasonable assurances of safety and effectiveness.4 Other considerations include that the device is being manufactured in accordance with FDA’s quality system requirements.5
Similarly, in accordance with section 513(f)(2) of the FD&C Act, sponsors of devices that have been determined to be not substantially equivalent (NSE) through the 510(k) program may be eligible to submit a de novo petition requesting FDA to make a risk-based classification determination for the device under section 513(a)(1) of the FD&C Act.6 Because devices classified under this pathway (de novo devices) are low to moderate risk devices, they may not need to confer as substantial a benefit to patients7 in order to have a favorable benefit-risk profile. Devices granted marketing authority under de novo petitions should be sufficiently understood to explain all the risks and benefits of the device such that all risks can be appropriately mitigated through the application of general and/or special controls to provide reasonable assurance of safety and effectiveness. Further, devices classified under de novo petitions may serve as predicates for future devices which can be appropriately regulated through the 510(k) program; therefore, FDA carefully considers the benefit-risk profile of these devices in the determination that there is reasonable assurance of safety and effectiveness.
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