FDARA Reauthorizes Device User Fees and Amends Key Device Provisions of FDCA

Last month, President Trump signed the FDA Reauthorization Act of 2017 (FDARA).  FDARA reauthorizes the Medical Device User Fee Amendments (MDUFA), allowing FDA to collect medical device user fees for fiscal years 2018 to 2022 after FDA’s current user fee authority ends on September 30, 2017.  Notably, the reauthorized MDUFA adds a substantial new user fee for de novo classification requests.  FDARA also contains important substantive amendments to the FDCA, including provisions modifying FDA’s approach and procedures for device establishment inspections, clarifying the premarket review process for medical imaging devices intended to be used with an approved contrast agent, addressing the classification of accessory devices, and requiring FDA to report on servicing of devices.

A full summary of the device-related provisions of FDARA is available in our recent Covington alert.

FDA Finalizes Guidance on Interoperable Medical Devices

On September 6, 2017, FDA finalized a guidance document entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices” (“Final Guidance”).  In the Final Guidance, the agency outlines design considerations for manufacturers when developing interoperable medical devices, as well as recommendations about information to include in premarket submissions and device labeling.  Interoperability of devices can encourage the availability and sharing of information across systems, even when products from different manufacturers are used.  A draft of this guidance was issued on January 26, 2016.

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FDA Releases Digital Health Innovation Action Plan and Initiates Software Pre-Certification Pilot Program

In two new posts on the Covington Digital Health blog we analyze the Digital Health Innovation Action Plan recently released by FDA and the agency’s new software pre-certification (Pre-Cert) pilot program.

The Digital Health Innovation Action Plan describes the agency’s “next steps” over the coming year to “encourage digital health innovation by redesigning [FDA’s] policies and processes and modernizing [the agency’s] tools so that they match the needs of digital health technology, and providing clarity on those policies and processes so that manufacturers and developers know what they need to do.”  The action plan includes three action items: (1) issuing new guidance regarding the regulation of digital health, (2) developing new regulatory approaches to oversight of digital health, including a new Pre-Cert program, and (3) building expertise on digital health within the agency.

The Pre-Cert pilot program is the agency’s first step in developing the Pre-Cert program.  Under the Pre-Cert program, FDA intends to pre-certify software developers who demonstrate sufficient quality performance.  Pre-certified software developers would be able to market their software devices with no, or streamlined, premarket review.  The goal of the pilot is to leverage input from the participating companies to help the agency establish the appropriate criteria for pre-certification and appropriate review process for pre-certified companies.

FDA Announces a New Digital Health Innovation Plan

FDA Commissioner Scott Gottlieb, M.D. recently announced the agency’s Digital Health Innovation Plan (the “Plan”)—a new agency-wide initiative to foster “innovation at the intersection of medicine and digital health technology.”  Dr. Gottlieb provided an overview of the components of the Plan, which include: (1) guidance documents implementing the digital health provisions of the 21st Century Cures Act; (2) guidance documents on low-risk digital health products; (3) a third-party certification pilot program; and (4) use of real-world evidence to support the development of digital health products.  While the Commissioner previewed the new Plan, he explained that details of each component would be forthcoming.  The Plan appears to align with the approach previously advanced by the Center for Devices and Radiological Health (CDRH) regarding digital health. Continue Reading

EU Vote on First Borderline Decision Confirms: Cranberry Products Are Not Medical Devices

The EU Regulatory Committee on Medical Devices recently voted in favor of the European Commission’s draft decision on the classification of cranberry products (the “Cranberry Decision”).  In essence, the Cranberry Decision provides that cranberry products intended to prevent or treat cystitis and that have a principal intended action based on proanthocyanidins (“PACs”) do not fall within the definition of medical devices.  The European Commission adopted its draft decision based on Article 13(1)(d) of Directive 93/42/EEC (the “Medical Devices Directive”).

The vote comes more than one year after the Commission prepared a draft decision, in February 2016 (see our analysis of that draft decision here).  The formal adoption and publication of the Cranberry Decision are expected later this summer.  This article first briefly summarizes the regulatory context of EU borderline issues.  It then explains what triggered the decision, analyzes its content, and provides a brief outlook on what is coming next. Continue Reading

CFDA Issues Groundbreaking Proposals for Medical Device Regulatory Reform

Last month, the China Food and Drug Administration (CFDA) published drafts of four proposed policies in the form of circulars (or notices) for public comment. These proposed policies include significant reforms in the areas of the new drug and device approval process (“Circular 52”), clinical trial regulation (“Circular 53”), life-cycle management and post-marketing surveillance (“Circular 54”), and regulatory data protection and patent linkage (“Circular 55”). Continue Reading

Health Care Task Force Pre-Releases Report on Cybersecurity Days Before Ransomware Attack

Last week, the Health Care Industry Cybersecurity (HCIC) Task Force (the “Task Force”) published a pre-release copy of its report on improving cybersecurity in the health care industry.  The Task Force was established by Congress under the Cybersecurity Act of 2015.  The Task Force is charged with addressing challenges in the health care industry “when securing and protecting itself against cybersecurity incidents, whether intentional or unintentional.”

The Task Force released its report mere days before the first worldwide ransomware attack, commonly referred to as “WannaCry,” which occurred on May 12.  The malware is thought to have infected more than 300,000 computers in 150 jurisdictions to date.  In the aftermath of the attack, the U.S. Department of Health and Human Services (HHS) sent a series of emails to the health care sector, including a statement that government officials had “received anecdotal notices of medical device ransomware infection.”  HHS warned that the health care sector should particularly focus on devices that connect to the Internet, run on Windows XP, or have not been recently patched.  As in-house counsels understand, the ransomware attack raises a host of legal issues.  For example, a recent Covington alert addresses insurance coverage for ransom attacks.

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Federal Circuit Holds Patentee Cannot Use Retroactive Statutory Disclaimer to Avoid Patent Marking Statute, But Leaves Open a Key Question About the Statute’s Application

Last week, in its opinion in Rembrandt Wireless Technologies, LP v. Samsung Electronics Co., Ltd., the Federal Circuit resolved one question about patent marking under 35 U.S.C. § 287 but left another open—whether the marking statute applies on a claim-by-claim or patent-by-patent basis. The case stemmed from a jury verdict in the Eastern District of Texas finding that Samsung infringed two patents asserted by Rembrandt (US Patent Nos. 8,023,580 and 8,457,228) and awarding Rembrandt $15.7 million in damages.  Samsung appealed, raising several issues, including whether the district court properly denied Samsung’s motion to limit damages in light of Rembrandt’s alleged failure to mark articles embodying the ’580 patent. Continue Reading

EU Medical Devices Regulation Series: Potential for Easing Borderline Determinations?

Earlier this week, in a plenary vote, the EU Parliament endorsed the texts of the Regulation on Medical Devices (the “Regulation”—latest version available here) and the parallel Regulation on In-Vitro Diagnostic Medical Devices (the “IVD Regulation”—latest version available here).  This presents a good opportunity to have a closer look at one of the essential questions of the revision of the medical device rules, namely, whether the scope of the Regulation changes in comparison to that of the main Medical Devices Directive 93/42/EEC (the “Directive”).  We examine below the changes to the definition of a medical device and whether the Regulation affects borderline determinations.

As discussed in our earlier post, the borderline between medical devices, medicinal products, cosmetics and foods or food supplements is often blurred.  The Regulation sheds some additional light on the definition of a medical device and strengthens the Commission’s power in relation to the borderline issues.  Nevertheless, important questions continue to exist, for instance in relation to the pharmacological versus physical (or purely chemical) mode of action of a product.

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House Discussion Draft Released on Regulatory Approach for In Vitro Clinical Tests

On March 20, 2017, Rep. Larry Bucshon (R-IN) and Rep. Diana DeGette (D-CO) released a discussion draft of the Diagnostic Accuracy and Innovation Act (DAIA).  DAIA would regulate “in vitro clinical tests,” defined in the discussion draft as a “laboratory test protocol or finished product” intended for clinical use “in the collection, preparation, analysis, or in vitro clinical examination” of human specimens for the purpose of “identifying, screening, measuring, detecting, predicting, monitoring, or assisting in selecting treatment for a disease or other condition.”  According to Rep. Bucshon, DAIA is intended to establish a “flexible, risk-based approach” to regulation of IVCTs.

The following are some of the highlights from the discussion draft of DAIA: Continue Reading

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