The US Food and Drug Administration (FDA) on Monday published final guidance on the FD&C Act’s
least burdensome provisions for the regulation of medical devices, highlighting recent initiatives via newly added themes.
The 24-page document, which finalizes a draft from December 2017, is intended to reflect guiding principles that require “the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time.” The term “relevant” was added to the definition in the draft, underscoring the goal of minimizing regulatory-related administrative burden throughout the medical device total product lifecycle (TPLC).
Updates to FDA’s final guidance from 2002 were prompted after the enactment of additional least burdensome provisions under more recent legislation, including the Food and Drug Administration Safety and Innovation Act of 2012
and the 21st Century Cures Act of 2016.
The draft scope was expanded to include waivers by application under the Clinical Laboratory Improvement Amendments and to clarify that the statutory medical device definition covers device constituent parts of combination products.
The final guidance is largely similar to the draft
. It includes, however, new clarifications that promote relatively new initiatives within FDA and industry and are closely aligned with least burdensome principles. These relate to “just-in-time testing,” the use of FDA-recognized voluntary consensus standards, device submission efficiencies and FDA feedback regarding inspectional observations from device manufacturing facilities.
For the areas of submissions and voluntary consensus standards in medical device regulations, FDA fleshed out the drafted section on the “most efficient means of obtaining the evidence necessary to meet the regulatory need or standard.” The new clarifications around submission efficiencies speak to the recent push for greater use of the alternative approaches to demonstrating substantial equivalence via 510(k) programs established with the goal of achieving efficiencies in regulatory review processes.
“The Special 510(k) program leverages the Quality System regulation and design controls and the Abbreviated 510(k) program leverages guidance documents, FDA-recognized voluntary consensus standards and/or special controls,” FDA said. “One goal of both programs is to streamline 510(k) review either by reduced review time or administrative burden without compromising the quality of a substantial equivalence decision.” To further encourage use of these options, FDA finalized guidance on a new pathway
that builds on the abbreviated 510(k) approach and is expanding its special 510(k) program
The revised section on global harmonization, including voluntary consensus standards, reflects new developments achieved through the International Medical Device Regulators Forum (IMDRF). These include the 2018 final document on optimizing standards for regulatory use
. It now states that the use of standards “can also support global harmonization by creating consistent approaches to medical device development, manufacturing and evaluation,” compared to just device evaluation as initially drafted. Greater support for consensus standards also coincides with new liaisons IMDRF formed
with standards development organizations such as the International Organization for Standardization.
The final guidance’s sections on just-in-time testing and requesting feedback regarding inspection observations are new. Just-in-time testing relates to early feasibility studies
, which are the center of an initiative FDA recently tasked
to the Medical Device Innovation Consortium for more of these studies to be conducted domestically.
“The goal of FDA’s policy on IDEs [investigational device exemptions] for early feasibility studies is to facilitate the initiation of clinical studies in the United States earlier in the device development process than what has historically occurred, while ensuring the study has acceptable human protection measures for its participants,” the final guidance says.
Feedback from inspections also falls under compliance policies that support the goals of the least burdensome concept. The final guidance clarifies that a facility can request feedback on actions it proposed to take in response to observations noted at a site inspection, with a few caveats. This type of feedback “allows firms to understand whether they are on the right track and can resolve issues that may otherwise escalate to regulatory action.”
Also of note, the guiding principles were tweaked to include two new subprinciples on when industry should submit material to FDA that are least burdensome for FDA to review and when FDA intends to apply least burdensome principles in international medical device convergence and harmonization efforts. “The principles are based on sound science, the intent of the law, the use of alternative approaches and the efficient use of resources to effectively address regulatory issues,” FDA says.
Extending least burdensome principles throughout the medical device TPLC is also consistent with the agency’s push to strike the right balance between pre- and postmarket data collection. In addition to the final guidance, an effort that falls under this larger initiative relates to reclassification of new and existing medical device types. “FDA completed a review of 200 product codes of devices subject to the PMA [premarket application approval] process to assess whether these devices were candidates for a premarket/postmarket shift of data capture or reclassification,” the final guidance adds to the draft.