FDA issues over 12 major medical device guidances in a month and AI gets its first procedural billing code

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Regulatory News

De Novo Requests: FDA Finalizes Three Guidances
FDA finalized three guidance documents related to de novo classification requests for medical devices. The first guidance deals with the criteria the agency intends to use in assessing whether a request for an evaluation of automatic class III designation should be accepted for a full review. FDA also finalized guidance on user fees related to de novo requests. The third guidance deals with the different actions FDA may take on de novo requests, the effect each action has on goals under MDUFA IV for de novo requests received, and the different industry actions that may be taken on de novo requests. (RAPS 9/19/19)

510(k) Submissions: CDRH Releases Four Final Guidances
CDRH released four final guidance documents on the Special 510(k) program, the abbreviated 510(k) program, how to format traditional and abbreviated 510(k)s, and CDRH’s refuse to accept policy for 510(k)s. The 510k formatting guidance outlines and describes the 20 sections for traditional and special 510(k)s, which includes information on animal and clinical performance testing, proposed labeling, biocompatibility and software, among others. According to the final RTA guidance: “Until November 13, 2019, once FDA has determined a submission is appropriate for review as a Special 510(k) as described in the Special 510(k) Program guidance, and for all other 510(k) submission types, FDA intends to utilize the prior final RTA guidance to assess whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review.”
(RAPS 9/12/19)

Not Quite a Breakthrough Device, FDA Introduces New Safer Technologies Program
FDA released draft guidance to introduce a new, voluntary program (Safer Technologies Program” or “STeP”) for certain medical devices and device-led combination products that are expected to improve the safety of currently available treatments or diagnostics but are used for morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program. Similar to the Breakthrough Devices Program, STeP is comprised of two phases where interested sponsors formally request inclusion in STeP through a Q-submission and where FDA takes action to expedite the development of the device and the prioritized review of subsequent regulatory submissions.
(RAPS 9/18/19)

FDA continues to take steps to fulfill its commitment to strengthen and modernize the 510(k) medical device program
Agency released draft guidances outlining premarket performance criteria and testing methodologies for four specific types of devices under the Safety and Performance Based Pathway for medical devices. Manufacturers often conduct direct comparison testing to demonstrate that a new device is as safe and effective as the predicate device.. In the new pathway, the safety and performance characteristics of new devices are evaluated against a set of FDA-identified objective and transparent metrics consistent with the safety and performance characteristics of modern predicates.
(FDA 9/19/19)

Statement on new steps to advance digital health policies that encourage innovation and enable efficient and modern regulatory oversight
The guidances issued address key provisions of the 21st Century Cures Act, that offer additional clarity about where the FDA sees its role in advancing safe and effective digital health technologies. In addition to drafting new guidance on clinical decision support software, the FDA released final guidance explaining what digital health products are no longer devices and are no longer subject to FDA regulations. (FDA 9/26/19)

Patients Know Best: FDA Releases Draft Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations
FDA believes medical device clinical investigations designed with early input from patient advisors could lead to quicker study/research participant recruitment, enrollment and study completion, improved study/research participant commitment and compliance, less protocol revisions, streamlined data collection, and more relevant data on outcomes that are important to patients. (FDA Law Blog 9/27/19)


Payment News

Autonomous AI procedural code is groundbreaking for digital therapeutics
The American Medical Association has added a new procedural billing code for the use of an autonomous AI diagnostic system for diabetic retinopathy. This new billing code is the first instance of a payment structure for services involving autonomous AI. The hope is that this marks the beginning of the end of reimbursement limitations which have proven to be a significant barrier for emerging digital therapeutic devices. The autonomous AI in IDX-DR makes treatment decisions independently, therefore the establishment of the new billing code is an important first move beyond the historic system of payments which are based on the services and expertise of healthcare providers.
(MDDI online 7/31/2019)

Value-based care increases in industry payment arrangements
The Health Care Transformation Task Force announced in September that their member organizations are aiming to shift 75% of their business to value-based care insurance arrangements by the end of 2020. This move is in keeping with opinion from policymakers and industry experts who point to the reduction of dependence on the fee-for-service model as essential for reducing healthcare spending and improving quality of care. The Task Force members, including major insurance companies Aetna, Anthem, Blue Cross and Blue Shield, defines value-based payment arrangements as those which “successfully incentivize and hold payer and providers accountable” for the cost and quality of patient care.
(Modern Healthcare 9/24/2019)


The Simbex Regulatory and Reimbursement Recap is a monthly briefing for news in the regulatory and healthcare reimbursement space relevant to Simbex areas of expertise. The briefing is curated by Amaris Ajamil, PhD, Simbex Senior Quality Assurance/Regulatory Engineer, Angela Smalley, PhD, Simbex Centers Project Leader, Project Evaluation, and Mohammed Kazi, MS, Quality Systems Coordinator.  A story’s inclusion does not imply endorsement by Simbex.

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