FDA Outlines Priorities for Advancing Public Health and Wearable Technology Data are Impacting Health Insurance Policies

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Regulatory News

Sharpless Outlines FDA’s Key Priorities for Advancing Public Health
Acting FDA Commissioner Ned Sharpless sent an email to FDA staff outlining four main priority areas: assuring public health through emerging technologies, investing in FDA’s next generation expert workforce and infrastructure, modernizing frameworks and promoting and protecting consumer and patient safety. On the emerging technologies front, Sharpless discussed how FDA is trying to stay ahead of the curve while encouraging industry to adopt less costly and more reliable advanced manufacturing platforms. (RAPS 7/23/19)

FDA Recognizes Standards for Medical Device Interoperability, Safety Assurance Cases
ANSI/AAMI/ UL 2800-1: 2019—Standard for Safety for Medical Device Interoperability received FDA recognition as a “baseline set of requirements for assuring safe and secure interoperability for interoperable medical systems.” The standard is intended to support FDA’s 2017 final guidance on recommendations for premarket submissions of interoperable devices. Also recognized, AAMI’s TIR38 serves as a reference to guide the development of assurance cases, which aid in assuring and documenting the safety of medical device designs. (RAPS 7/24/19)

EC Issues Additional Guidance on Device Vigilance System
The January version of the Manufacturer Incident Report (MIR) introduces the use of the adverse event terminology/coding harmonized via the International Medical Device Regulators Forum and the use of unique device identification. The new MIR also introduces the concept of a single registration number, which will pre-populate a manufacturer’s details in the future Eudamed. From January 2020, the current version of the MIR must be included in device manufacturers’ databases. (RAPS 07/10/2019)

An EKG for the Knee
Emovi’s KneeKG evaluates knee functional deficiencies while the joint is in motion and bearing weight, providing physicians with more information about diseases or injuries than static technologies such as x-ray or MRI. The device is FDA cleared and indicated for appropriate assessment of the 3-D knee motion for patients who have impaired movement functions of an orthopedic cause, according to the company. (MDDI 07/19/2019)

First FDA-Developed Medical Device Development Tool Receives Qualification
A tissue mimicking material for use in the preclinical development and evaluation of ultrasound medical devices became the first medical device development tool (MDDT) developed by the FDA to receive FDA qualification. Device developers can use this MDDT to help test the safety of their high-intensity therapeutics ultrasounds devices before moving to clinical trials. (RAPS 07/15/2019)


Payment News

Health information gathered by wearable technology is impacting health insurance policies
Wearables allow for the tracking and measurement of massive amounts of health-related data. Technological advances in this area are moving at such a rapid pace that researchers and insurance companies are struggling to keep up. This trend is driving attention toward health and lifestyle choices as wearables decipher data and even “nudge” in an effort to influence daily behaviors. (British Actuarial Journal 7/18/19)

CMS considers coverage for acupuncture for patients with chronic low back pain
Currently, acupuncture is not a covered treatment for patients who are insured through CMS, but that may soon change.  Emphasis on opioid-alternative treatments for chronic pain makes acupuncture an increasingly attractive option. CMS is collaborating with ongoing NIH studies to monitor outcomes of patients treated with acupuncture. (CMS 7/15/19)

Ambulatory blood pressure monitoring coverage increased by CMS
A new national coverage determination has been issued by CMS which approves the expanded use of blood-pressure monitoring through the use of non-invasive tracking devices. Previously, this procedure was only approved for use in patients with clinical setting anxiety-related increases in blood pressure (white coat hypertension). It is hoped that this increased coverage will allow access to more accurate blood pressure monitoring for a wider range of patients. (CMS 7/2/19)


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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