FDA Issues Final Rule on Medical Device Classification Procedures

On December 17, 2018, FDA published a final rule, Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures, to amend its regulations governing classification and reclassification of medical devices to align with the relevant portions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA).  We previously blogged on the proposed changes here.  While FDA said that the final rule allows it to classify any device from class III to class I or class II, a process known as down-classification, it also makes it easier for the agency to increase product classification based on new or changing information to more appropriately reflect device risk.  FDA’s easier ability to up-classify devices may be particularly relevant in light of the Agency’s November 2018 announcement on new steps to modernize FDA’s 510(k) program. In this announcement, which we previously blogged on here, CDRH highlighted that it has eliminated the use numerous of 510(k)-cleared predicate devices via up-classification.  This up-classification process, involving 1,477 devices since 2012, had, historically, been both time- and resource-intensive. FDA’s use of this process could increase through the easier re-classification process.

FDASIA, which became effective on July 9, 2012, established a new process for requiring premarket approval (PMA) applications for pre-amendment class III devices and for the reclassification of devices by administrative order, rather than by rulemaking.  FDA is amending the provisions of its regulations governing reclassifications initiated by FDA to incorporate the process for issuing administrative orders and to update generally the part 860 regulations that govern the classification and reclassification of devices to conform them to the FDASIA changes and current FDA practices.  The final rule is essentially the same as the proposed rule.  For instance, just as described in the proposed rule, the final rule adds § 860.90 and amends § 860.125 to explain how and when FDA will consult with panels regarding classification of pre-amendment devices. However, citing that its intent was to provide clarity and not to implicitly change the classification/reclassification process, FDA did not incorporate the original proposed definitions.

Just like the proposed rule, the final rule states that prior to publication of a final order reclassifying a device or requiring a PMA application for a pre-amendments class III device in response to a petition, FDA must publish a proposed order in the Federal Register, consider any comments submitted on the proposed order, and hold a device classification panel meeting.  After consideration of comments on the proposed order and findings, FDA must either:

(1) finalize the call for PMAs by issuing an administrative order requiring approval of a PMA and publishing in the Federal Register findings with respect to:

(i) degree of risk or injury designed to be eliminated or reduced by requiring the device to have an approved PMA or a declared completed product development protocol and

(ii) the benefit to the public from the use of the device; or

(2) publish a notice in the Federal Register terminating the proceeding and initiate a reclassification proceeding based on new information.

This final rule, which will become effective March 17, 2019, also clarifies the process where reclassification of a post-amendments device or a transitional device is initiated by FDA, rather than in response to a petition.  This rule details the procedures, which consist of a proposed reclassification order, optional panel consultation, and a final reclassification published in the Federal Register following consideration of comments and any panel recommendations or comments (amended §§ 860.134(c) and 860.136(c) of this final rule.

A post-amendments device remains in class III and is subject to the PMA requirements unless and until: (1) FDA reclassifies the device into class I or II; (2) FDA issues an order classifying the device into class I or II via the De Novo classification process; or (3) FDA issues an order finding the device to be substantially equivalent to a predicate device that does not require the filing of a PMA.

This final rule also removes the requirement for a hearing under part 16 (21 C.F.R. Part 16) for reclassifying transitional devices.  Transitional devices are devices that were regulated by FDA as new drugs before May 28, 1976; any class III device that was approved by a New Drug Application is now governed by PMA regulations.  FDA believes the process providing for a proposed order, panel consultation as appropriate, consideration of comments, and final order provide sufficient opportunity for participation and review of reclassification of transitional devices.

Additionally, the final rule removes two definitions (§ 860.3(f) and (g)) associated with classification questionnaire and supplemental data sheet.

We believe that the finalization of this rule simplifies procedures for classifying and reclassifying medical devices yet it makes it easier for the agency to make changes on an existing classification based on new or changing information.  For example, FDA proposed to down-classify medical image analyzers applied to mammography breast cancer and ultrasound breast lesions from class III to class II. This shows that as FDA became more comfortable with these devices, they intended to reduce regulatory burdens on industry by no longer requiring a PMA and accepting a 510(k).  On the other hand, this rule could be problematic if FDA begins to up-classify more devices through the simplified process.

* Senior Medical Device Regulation Expert