New Digital Health Center of Excellence & Coverage for “Breakthrough” Devices

 In News, Regulatory & Reimbursement Update


FDA launches digital health center of excellence

A new digital health Center of Excellence within the FDA aims to boost digital health innovation by fostering partnerships and connections among digital health stakeholders. The DHCoE’s website details services offered, including examples of CDRH-specific, FDA-wide and external efforts to “translate digital advances into tools that benefit consumers.” Among the other offerings within the DHCoE is a Network of Experts that has now been formalized into a “permanent, specialized pool of expertise.” The expert pool is available for consultation to CDRH staff in such topic areas as artificial intelligence, wearables, digital therapeutics, real-world evidence, cybersecurity and more. (RAPS 9/23/20)

UK MHRA issues new guidance on post-Brexit medical device regulatory compliance

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has posted new guidance regarding medical devices placed on the market in Great Britain (and Northern Ireland and European Union (EU)) starting January 1, 2021 in anticipation for hard Brexit. The MHRA continues to be the central authority for medical device market oversight in the UK. After this no-deal Brexit the UK will be considered a third country. This means that UK-based manufacturers need an Authorized Representative and importer, both located in the EU-27. EU CE Marking will be recognized through June 30, 2023. On June 30, 2023, CE-marked devices must be compliant to the new legislation and must possess the UK Conformity Assessment. on January 1, 2020 there are new MHRA registration requirements for devices placed on the UK market. (Emergo 9/3/20)

US FDA releases draft guidance on patient-reported outcome instruments

FDA released a draft guidance document that aims to help medical device manufacturers, FDA staff, and other stakeholders utilize patient-reported outcome (PRO) instruments for medical device evaluation. PRO instruments are questionnaires designed to record PROs in the form of data that can be utilized for clinical assessment of a device’s safety and effectiveness. The draft guidance offers principles, recommendations, and an outline of best practices for choosing, creating, and altering PRO instruments to inform medical device evaluation. (Emergo 9/23/20)

FDA issues proposed rule clarifying stance on intended use

FDA has proposed a new rule clarifying its position on the types of evidence it will consider when determining a product’s intended use. A new sentence explains that, “A firm would not be regarded as intending an unapproved new use for an [approved or cleared medical product] based solely on that firm’s knowledge that such [product] was being prescribed or used by health care providers for such use,” clarifying that the firm’s knowledge of an unapproved use would not, by itself, trigger new labeling obligations (RAPS 9/23/20)

FDA updates Pre-Cert pilot for SaMD

Lessons learned from a digital health software pilot pre-certification program have readied the FDA to test an updated version of the continuous evaluation program for developers of software as a medical device (SaMD). The precertification (Pre-Cert) pilot will help inform the development of a future regulatory model that will provide more streamlined and efficient regulatory oversight of software-based medical devices. It will be available for manufacturers who have demonstrated a robust culture of quality and organizational excellence, and who are committed to monitoring real-world performance of their products once they reach the US market.  (RAPS- 9/14/2020)

US FDA updates final guidance on ISO 10993 for medical device biocompatibility 

FDA released a clarified guidance on how manufacturers should utilize the ISO 10993 standard for biological evaluations of medical devices. Notably, the guidance contains an updated FDA-modified matrix to identify and determine biocompatibility endpoints for evaluations of devices and manufacturer considerations when device labels include claims that a device is free (“-Free”) of a particular substance. (EMERGO- 9/15/20)


CMS proposes Medicare coverage of “Breakthrough” medical devices 

CMS issued a proposal to reduce the delay between FDA approval and Medicare coverage of innovative medical technology. Under this new plan, coverage would be available for FDA-designated breakthrough medical devices on the same day that they receive FDA market authorization.  This coverage would last for four years, which is intended to allow manufacturers the opportunity to gather efficacy evidence and seek permanent coverage. (Fierce Healthcare 8/31/20)

CMS announces effort to codify the definition of “reasonable and necessary” 

CMS has long used the phrase “reasonable and necessary” to describe its coverage criteria. CMS is seeking to formalize the meaning of this phrase to include the following: the item or service is safe and effective, not experimental or investigational, and is appropriate for Medicare patients. More specifically, the item or service must be furnished in accordance with accepted standards, in appropriate settings, by qualified personnel. The item or service must meet but not exceed the patient’s medical need and be at least as beneficial as existing alternatives.  (HME News 9/1/20)

Health insurance provider Centene provides smartphones to rural and underserved patients 

Centene Corporation has partnered with Samsung to send Galaxy smartphones to patients who do not have other means to access virtual visits. About 13,000 members in rural and underserved areas received the phones and 90 days of free coverage. Centene CEO stated that this program demonstrates the insurer’s belief that telehealth solutions have the potential to significantly improve access to care. (Becker’s Hospital Review 9/14/20)

Digital therapeutic products added to list of standard covered benefits 

reSET and reSET-O, two products by Pear Therapeutics, were added to the list of standard medical benefits by health insurance company PreferredOne. Inclusion in this list will enable PreferredOne members to access the digital therapeutic products like another other medication or treatment. Both reSET and reSET-O are adjunctive to outpatient counseling and are used to treat substance use and opioid use disorders.  (Businesswire 9/21/20)

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, RAC, Simbex Senior Quality Assurance/Regulatory Engineer, Angela Smalley, PhD, Simbex Centers Project Leader, Project Evaluation, and Mohammed Kazi, MS, Simbex Quality Systems Coordinator.  A story’s inclusion does not imply endorsement by Simbex.

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