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Regulatory News

Osteoarthritis: FDA Drafts Guidance on Developing Drugs, Devices, Biologics
FDA published draft guidance to help drug, device, and biologic sponsors develop products to treat the underlying pathophysiology and structural progression of osteoarthritis.
(RAPS 08/22/18) Pain Management

ISO Preps for FDA’s Proposed Overhaul of Device Quality System Regulation
FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with ISO 13485:2016. The revisions are intended to reduce compliance and record keeping burdens on device manufacturers by harmonizing domestic and international requirements.
(RAPS 8/28/18) General 

FDA Clarifies Policies on Acceptable Levels of Uncertainty for Devices
Guidance updates the current framework on acceptable levels of uncertainty in regulatory decision-making for medical devices.
(RAPS 9/5/18) General 

510(k) Reviews: FDA Launches ‘Quik’ Pilot
FDA launched a new pilot program aimed at reducing the time it takes to review moderate-risk medical devices by one-third. The pilot will allow sponsors of moderate risk medical devices from some 40 eligible product codes to use FDA’s free “eSubmitter” software to complete and submit their 510(k)s. The agency will be able to cut its review time for 510(k)s submitted through the pilot from 90 days to just 60 days without changing any statutory or data requirements.
(RAPS 9/6/18)  General 

CDRH Offers Peak Into Plans for Early Feasibility Studies, Use of External Evidence
Pilot program on incorporating external evidence into pre- and post-market regulatory decision-making will be launched this fall. This collaboration between MDIC and CDRH, among others, seeks to support the community needed to ensure long-term success of virtual trial designs using Bayesian-designed tools, building off of FDA guidance finalized in 2016.
(RAPS 9/6/18) RWE

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices; Guidance
Appropriate use of voluntary consensus standards can reduce requests from FDA staff for additional information.
(FDA 9/14/18) General 

FDA Finalizes Guidance on Benefit-Risk Factors for 510(k)s
Guidance is meant to address situations when a new device carries an increase in risk accompanied by an increased or equivalent benefit or when a new device carries a decreased risk and a decreased or equivalent benefit compared to its predicate device.
(FDA 9/05/18) General 

OIG to FDA: Better Integrate Cybersecurity Into Device Review Process
OIG notes that currently FDA’s “Refuse-To-Accept” checklists do not include checks for cybersecurity information. However, FDA reviewers do look for cybersecurity documentation in submissions, and such documentation may include a hazard analysis or a matrix that describes a device’s cybersecurity risks, controls to mitigate those risks and threats the manufacturer considered.
(RAPS 9/11/18) Software

Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Allowed in Electronic Format
FDA is proposing to amend requirements for medical device premarket submissions to remove paper and multiple copies and replace them with requirements for a single submission in electronic format in line with IMDRF.
(Federal Register 9/13/18) General 


Payment News

New Program with Payors Aims to Accelerate Patient Access to Medical Devices
The Private Payor Program is a voluntary opportunity for manufacturers to receive feedback from the FDA and other non-governmental health technology assessors/payors. By facilitating communications between device makers and payors, the FDA hopes to shorten the time between FDA approval and coverage decisions.
(FDA 9/5/18) General

AdvaMed lobbying CMS for speedy Medicare coverage of breakthrough devices
AdvaMed hopes that CMS will follow suit with FDA’s breakthrough device designation and allow Medicare coverage when approved.
(MedTechDive 9/25/18) General

Insurers say a small change to FCC regulations will have a big impact on their ability to text and call patients
Although the 2015 FCC TCPA order allows organizations to make “healthcare calls,” the group wants that definition to align with HIPAA to specify “treatment, payment, and operation.” The change would give organizations the legal platform to collaborate with one another on patient outreach. Increasingly, insurers and other healthcare organizations are using text message reminders to offer reminders for prescription refills or appointments and provide post-discharge research shows such reminders can improve medication adherence and care coordination.
(FierceHealthcare 8/29/18) Software

Orthotic Solutions secures PDAC approval in US for Lumbrella device 
Orthotic Solutions received PDAC approval for its Lumbrella device, a new class of prefabricated customizable Lumbosacral Orthosis design to bridge the gap between traditional prefabricated bracing and custom fabricated spinal bracing.
(Compelo 9/26/18) Rehab & AT


MarketWatch

Venture Heat Warms up Wearables with New FDA Nod
Venture Heat received FDA clearance for its Infrared Heat Therapy Pain Relief using Far Infrared Rays (FIR). Venture Heat’s products safely use low 12-V DC for plugin use at home and a 12-V Lithium Ion battery for use on the go.
(MDDI 9/17/18) Pain Management

Six pediatric device innovators awarded total of $150,000 at Children’s National 6th Annual Pediatric Device Symposium
Competition awards expanded because of high caliber of medical devices presented for pediatric cardiovascular patients.
(PR Newswire 9/26/18) Pediatrics

BrainScope lands $4.5M to add vision assessment to its technology
BrainScope One is the first FDA-cleared medical device that can assess the full spectrum of brain injury – from concussions (functional abnormality) to brain bleeds (structural injury). The U.S. Department of Defense has awarded BrainScope a $4.5 million research contract to create and integrate ocular capabilities into its handheld, multi-parameter mild traumatic brain injury (mTBI) and concussion products.
(MassDevice 9/4/18) Injury Prevention

PathMaker Neurosystems Launches European Clinical Trial
In 2017, FDA selected the MyoRegulator as one of the first breakthrough medical devices selected for the Expedited Access Pathway (EAP) program. The MyoRegulator device’s DoubleStim technology uses a combination of simultaneous non-invasive spinal and peripheral stimulation.
(MDDI 9/6/18) Pain Management

DHS warns on BD’s Alaris pump
DHS warned consumers that BD’s Alaris syringe pumps can be hacked via a vulnerability that gives a remote attacker unauthorized access to the device when it is connected to a terminal server.
(MassDevice 8/24/2018) Software

GE, DARPA are taking on Type 2 diabetes with electricity
The GE bioelectronic medicine team aims to demonstrate that its new, non-invasive, stimulation technique can be used to reverse or treat diabetes in pre-clinical models. This diabetes project is part of a growing body of research in the field of bioelectronic medicine that is exploring new ways to treat chronic diseases such as diabetes by using electronic devices to correct dysfunctions in the peripheral nervous system that are believed to be key contributing factors to these diseases.
(MassDevice 9/13/18) General

Report: Prosthetic maker Ottobock to expand into exoskeletons
The company is developing the Paexo wearable upper-body exoskeleton intended to reduce the physical strain of repetitive overhead assembly work. The Paexo is a passive exoskeleton that transfers weight of the raised arms to the hips through a mechanical cable technology and is intended to be worn for full eight-hour shifts.
(MassDevice 9/13/18) Rehab & AT


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 Research Engineer and Cassie Brugger, MA, Simbex Centers Senior Program Administrator.  A story’s inclusion does not imply endorsement by Simbex, LLC.

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