The Advancing Landscape of Medical Device Submission Exemptions

There have been several efforts in recent years to help reduce the lengthy, costly, and timeconsuming process for U.S. Food and Drug Administration (FDA) review and clearance of lower risk devices. The requirement of a 510(k) premarket notification submission to the FDA has applied to Class II devices generally, while almost all Class I devices are exempted from this requirement. Now, FDA is moving toward expanding the 510(k) exemption to well-established Class II devices. This shift is designed to provide additional FDA resources for the evaluation of higher risk products — all in an effort to make such products and treatments available to prospective patients in a timelier fashion.

The 21st Century Cures Act (Cures Act), enacted on December 13, 2016, was designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently. The law expanded FDA’s ongoing work to incorporate patient perspectives into the development of drugs, biological products, and devices and to help streamline the ultimate approval, clearance, and availability of such products. Section 3054 of the Cures Act amended section 510(m) of the U.S. Food, Drug and Cosmetic (FDC) Act to permit FDA to exempt a Class II device from the report requirement under section 510(k) of the FDC Act if it determines that an additional report is not necessary to provide a reasonable assurance of the safety and effectiveness of the device. The request for exemption can be made on FDA’s own initiative or upon a petition of an interested person. This means there could be an increase in the number of Class II, 510(k) exempt devices. Examples of such devices range from acid phosphatase test systems (21 CFR 862.1020) to ultrasonic pulsed echo imaging systems (21 CFR 892.1560).

The FDA Reauthorization Act of 2017 allows reclassification of certain accessories, notwithstanding the classification of the devices that use such accessories. Since accessories are usually classified the same as the primary device, there are several Class II simple devices that could now be declassified (i.e., moved from Class II to Class I). The goal of this reclassification opportunity is to reduce the regulatory burden for devices with the lowest risk and to help FDA focus its resources on the review and approval of innovative and newly developed products that require a rigorous review. Being reclassified to a Class I device means the device would likely be 510(k) exempt.

There are a number of factors FDA may consider when determining whether a 510(k) clearance is necessary to provide a reasonable assurance of the safety and effectiveness of a Class II device. To determine whether premarket notification is necessary for Class II devices, FDA considers if: (1) the device has a significant history of false or misleading claims or of risks associated with inherent characteristics of the device; (2) characteristics of the device necessary for its safe and effective performance are well established; (3) changes to the device that could affect safety and effectiveness will either be (a) readily detectable to users by visual examination or routine testing before causing harm, or (b) not a material increase in the risk of injury, incorrect diagnosis, or ineffective treatment; and (4) any changes to the device would likely result in a change of the device’s classification.

Exempting a well-established device from 510(k) submission is both a cost and time savings to the manufacturer. Such exemptions, however, do not preclude the manufacturer’s need to establish and maintain Good Manufacturing Practices (GMP), especially design controls for Class II devices. While certain limited Class I devices identified by FDA are also exempted from the GMP regulation, Class II devices are not exempt from GMP requirements, even if they become 510(k) exempt. Therefore, maintenance of design history files with complete design controls for Class II, 510(k) exempt products, is still required and will certainly be a focus during normal, on-site FDA inspections.

It is exciting that FDA has engaged with the government and public communities to help accelerate medical product development in order to bring new innovations and advances to market. Mechanisms that allow FDA to evaluate higher risk submissions more readily include the reduction of submission requirements for lower risk devices and reclassification/exemption of lower risk devices. These changes allow FDA to allocate more people power to the review, clearance, and approval of novel treatments and devices that both the medical community and the general public desire. Manufacturers will appreciate that the submission requirements for lower risk devices may decrease but must understand that the necessity of design controls and GMP remains.