Major Updates to Biocompatibility, Cybersecurity, and FDA Premarket Activity Regulations and New AMA Report on Commercial Coverage of Digital Care

 In Blog, News, Regulatory & Reimbursement Update


Complete Rewrite of ISO 10993-1 Creates Industry Buzz

The proposed draft for the next revision of ISO 10993-1 represents a complete overhaul. The draft also takes a strong position on further aligning the standard to general risk management standard ISO 14971. The document has been restructured to make it easier to follow the recommended flow for biological evaluations: beginning with a plan (the main focus of the document), performing the testing, and finally ending with a summary report to tie everything together. Another update to the standard is a clearer description of how to calculate cumulative use. In addition to this clarification, one large item that has been brought into the document is the term ‘(reasonably) foreseeable misuse,’ whereas before the evaluation was based on ‘intended use’ only. For categorizations pertaining to contact type and duration, the draft has removed the term ‘transitory contact’. It now only states that it may be possible for the manufacturer to prepare a written justification that there is no significant biological interaction with the tissues. Along these lines, a new section about ‘insignificant risk skin contact’ has been added to the draft that highlights that devices that contact skin during normal handling and are made of materials that are in common use for consumer products, with similar nature of contact, are considered to have no significant risk. For these devices, a simple written justification in the biological evaluation report (BER) will be sufficient.

(MDDI Online 9/11/23)

Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process”; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Use of International Standard ISO 10993-1, `Biological evaluation of medical devices–Part 1: Evaluation and testing within a risk management process’.” This guidance was revised to incorporate updates to FDA’s current thinking regarding the type of biocompatibility information that should be provided in a premarket submission for certain devices made from common polymers and fabrics that are in contact with intact skin. The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices–Part 1: Evaluation and testing within a risk management process” to support premarket approval applications (PMAs), humanitarian device exemptions (HDEs), investigational device exemption (IDE) applications, premarket notifications (510(k)s), and De Novo requests.

(FDA Federal Register 9/8/23)

FDA Issues Final Guidance on Cybersecurity in Medical Devices

The FDA has issued the final guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. This document provides recommendations on medical device cybersecurity considerations, device design and labeling, and what information to include in premarket submissions. The guidance emphasizes that cybersecurity is part of device safety and the quality system requirements found in 21 CFR Part 820, which may be relevant at the premarket stage, postmarket stage or both. The guidance recommends that manufacturers use device design processes such as those described in the QS regulation to support secure product development and maintenance. But, to preserve flexibility, they may use other existing frameworks that satisfy the QS regulation and align with FDA’s recommendations for using a Security Product Development Framework (SPDF).

(MedTech Intelligence 9/26/23)

Preparing for the PATCH Act and RTA

The Protecting and Transforming Cyber Health Care Act of 2022 (PATCH Act) comes into force on October 1, 2023. The Act strengthens cybersecurity requirements for medical device pre-market submissions and post-market surveillance. Companies must develop a product monitoring plan, cyber-anomaly response plan, coordinated messaging of cyber vulnerabilities, Software Bill of Materials (SBOM) and demonstrate the ability to release critical vulnerability patches ‘as soon as possible.’ In accordance with the Patch Act, the FDA announced that it may Refuse to Accept (RTA) premarket submissions that do not meet these requirements, beginning on October 1, 2023.

(MedTech Intelligence 9/27/23)

510(k) Modernization 2023

The Food and Drug Administration (FDA or Agency) is announcing the availability of three draft guidances entitled “Evidentiary Expectations for 510(k) Implant Devices,” “Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions,” and “Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission.” FDA is issuing these guidances to improve the predictability, consistency, and transparency of the 510(k) premarket review process. The electronic Submission Template and Resource (eSTAR) program, which we blogged about here and here, also makes the highlight reel given its aim to improve consistency and efficiency in how 510(k)s are prepared. Use of the eSTAR template for 510(k)s becomes mandatory on October 1, 2023 (unless exempt as described in the final guidance). Finally, the announcement notes that FDA will be engaging with manufacturers that are marketing pre-amendment status devices to ensure that the preamendment status for these devices is still applicable.

(FDA Law Blog 9/12/23)

FDA Updates Breakthrough Devices Program Guidance

The FDA has issued an update to the final guidance: Breakthrough Devices Program. The updates are intended to clarify how the Breakthrough Devices Program applies to certain innovative medical devices that may address health inequities, as well as devices that may offer a non-addictive option to treat pain or addiction. the guidance clarifies the FDA’s current interpretation of the Breakthrough Device designation criteria. In particular, the update explains that the FDA’s interpretation of “more effective” is based upon the totality of available information about the device, including the potential for the device to make a clinically meaningful impact and the risks and benefits compared to standard of care. The final guidance also explains that the FDA may consider improved accessibility of a device when evaluating if it could meet the first breakthrough criterion. When evaluating the first Breakthrough criterion, FDA intends to consider technologies and device features that could allow for improved accessibility when evaluating whether the device may provide for more effective treatment or diagnosis as compared to the current standard of care. For example, if there is information supporting the device’s use in diverse settings such that a patient population with limited or no available options may have improved adherence to a prescribed medical regimen. As of June 30, 2023, CDRH has granted Breakthrough Device designation to 831 devices and granted marketing authorization to 77 devices with Breakthrough Device designation.

(MedTech Intelligence 9/20/23)

Logistics Unwrapped: A Roadmap to Successful FDA Meetings in In-Person and Hybrid Formats

CDRH recently announced its acceptance and hosting of in-person meetings, including hybrid options that allow for both physical and virtual participation. Drawing from our recent experiences, we outline practical tips to enhance your experience when engaging in these crucial interactions with CDRH.

(FDA Law Blog 9/17/23)


New AMA report on commercial coverage of digital care

This report by the American Medical Association (AMA) outlines the current landscape of digitally enabled care, emphasizing the need to bridge the “digital health disconnect” through policy redesign and stakeholder commitment. The report provides a blueprint for optimizing digitally enabled care with foundational pillars, including focusing on patients and clinicians, equity, the patient-physician relationship, payment models, and reducing fragmentation. Stakeholder opportunities are identified for physicians, health plans, employers, policymakers, health tech companies, and venture capital/private equity funds. The summary also highlights the importance of Current Procedural Terminology (CPT®) codes in supporting digitally enabled care payment pathways and reveals challenges in the alignment, adoption, transparency, and utilization of digital medicine CPT codes across commercial, Medicare, and Medicaid plans, calling for further research on the impact and quality of digital medicine services.

(AMA 9/18/23)

House Subcommittee discussed access to MedTech innovation

On September 19, 2023, the House Committee on Energy and Commerce Subcommittee on Health convened a hearing titled “Examining Policies to Improve Seniors’ Access to Innovative Drugs, Medical Devices, and Technology.” The hearing discussed various pieces of legislation and raised specific concerns of healthcare access barriers and described potential pathways for improvement. Much emphasis was placed on the lengthy delay of national coverage after FDA clearance. Dr. Hughes repeatedly stated that national coverage determinations are not the only mechanism for coverage and that local and individual coverage decisions can also be leveraged for access. Witnesses included Dr. Dora Hughes, MD, MPH, Acting Director, Center for Clinical Standards and Quality, Acting Chief Medical Officer, U.S. Centers for Medicare and Medicaid Services, and Mr. John Dicken, Director, Health Care, Public Health and Private Markets, U.S. Government Accountability Office.

(Energy and Commerce Committee 9/19/23)

A systematic review of RPM benefits and challenges

Remote patient monitoring (RPM), also known as telemonitoring, provides healthcare professionals with the means to collect real-time data on patients’ physiological states. Given the growing significance of telemedicine and telemonitoring in contemporary society, it is essential to grasp healthcare practitioners’ viewpoints. This systematic review aims to assess the outlooks and encounters of healthcare professionals concerning telemonitoring technologies.

(The Permanente Journal 09/22/23)

Data shows the effect of Pear on Medicaid bills in Massachusetts

While Pear Therapeutics may no longer be operational, one of its pivotal agreements continues to spark essential discussions about the integration of medical apps within the often sluggish healthcare system. In recent months, representatives from the Massachusetts state Medicaid program, MassHealth, have presented data showcasing the cost savings achieved through Pear’s prescription apps, reSET and reSET-O, designed to address substance use disorder and opioid use disorder. These findings, considering healthcare utilization before and after app usage, have been shared with policymakers deliberating the coverage of innovative digital health products. Additionally, the data has been presented to lawmakers considering federal legislation mandating Medicare coverage for prescription apps. Pear, despite its recent bankruptcy, stood as a leading company in the promotion of prescription digital therapeutics—FDA-cleared apps designed for disease treatment. Notably, Pear’s reSET became the first such app to receive FDA clearance back in 2017.

(Stat News 9/19/23)


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 Director, Quality and Regulatory, and Angela Presley, PhD, Simbex Senior Product Consultant.  A story’s inclusion does not imply endorsement by Simbex.

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