AI Update: Medical Software and Preemption

In light of the rapidly expanding field of medical software technology, and its recognition that traditional approval mechanisms for hardware-based medical devices may not be well suited to regulating such technology, FDA is piloting a new, streamlined regulatory approach for digital health technologies. The initiative, currently a “working model” and known as the Software Precertification Program, is meant to encourage the development of health and medical software, including potentially software using artificial intelligence. Continue Reading

FDA Finalizes Voluntary Malfunction Summary Reporting Program to Streamline Manufacturer Reporting

On August 17, 2018, FDA announced that it finalized its Voluntary Malfunction Summary Reporting Program (“Program”).  The Program is intended to reflect the goals for streamlining manufacturer malfunction reporting that FDA and industry agreed to in the Medical Device User Fee Amendments 2017 (MDUFA IV) Commitment Letter.  The finalized Program is based on positive findings from a 2015 pilot program and public comments submitted to a 2017 Federal Register proposal.

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Medicare Policies Modified to Support Smart Devices Use for Sharing Glucose Data

The Centers for Medicare & Medicaid Services (CMS) recently announced that Medicare coverage policies would be revised “to support the use of [continuous glucose monitors] in conjunction with a smartphone, including the important data sharing function they provide for patients and their families.” In turn, the agency’s contractors, known as Medicare Administrative Contractors (MACs), modified their policies in part to recognize “the use of smart devices (watch, smartphone, tablet, laptop computer, etc.)” (see CMS and MAC announcements here and here). This recent shift is an important precedent for technologies that incorporate the use of electronic devices to display and share medical data, and may foreshadow flexibility in future federal policy development to support the important role smart devices are increasingly playing in communicating medical data. Continue Reading

FDA Issues Two Final Guidances on Communications Not Included In Product Labeling

Last month, FDA issued two final guidances on medical product communications, including communications by medical device companies about unapproved uses of approved/cleared medical products: “Medical Product Communications That Are With the FDA-Required Labeling—Questions and Answers” (CWL Guidance) and “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers” (Payor Guidance). Taken together, these guidances provide considerable additional flexibility for medical device manufacturers to communicate truthful and non-misleading information about their products to health care professionals, payers, and other customers.

Although the final guidances are largely consistent with the draft guidances, issued in early 2017 (available here and here), they provide answers to some questions left open by the draft guidances and new insights into FDA’s thinking on these issues. Continue Reading

Federal Circuit Decision in Medical Device Case Sheds Light on “Exceptionality” Analysis for Attorney Fees

In Stone Basket Innovations, LLC v. Cook Medical LLC, a recent case involving the enforcement of a medical device patent, the Federal Circuit affirmed a district court’s denial of attorney fees under 35 U.S.C. § 285. In its opinion, the court provided helpful guidance regarding the factors that impact a potential award of attorney fees and how a party can position itself for success on a § 285 motion.

In April 2015, Stone Basket Innovations (Stone Basket) filed a patent infringement lawsuit against Cook Medical (Cook), alleging infringement of U.S. Patent No. 6,551,327, a patent directed to a basket-type device used to remove stones from biological systems. In March 2016, Cook filed a petition for inter partes review (IPR) of all claims of the patent. The IPR was instituted as to all claims of the patent and the district litigation was stayed pending the IPR. In December 2016, Stone Basket filed a motion requesting an adverse judgment in the IPR proceeding. The PTAB granted the motion and cancelled all claims of the ‘327 patent. At Stone Basket’s request, the district court litigation was dismissed with prejudice. Following the dismissal, Cook filed a § 285 motion, which was denied because the district court determined that the case was not “exceptional.” The Federal Circuit affirmed. Continue Reading

CMS Announces Enforcement Discretion for New Laboratory Date of Service Exception

This week, the Centers for Medicare & Medicaid Services (CMS) announced (see announcement here) that it is exercising enforcement discretion until January 2, 2019 for its new Medicare laboratory billing rule on the date of service exception. This agency action allows hospitals to continue to bill for affected advanced diagnostic laboratory tests (ADLTs) and molecular pathology tests until the hospitals and those laboratories that would otherwise be responsible for billing under the new rule have developed a billing system that enables the performing laboratory to bill for the tests. CMS made its enforcement discretion decision in response to industry feedback, which suggested that additional time was needed to meet the new rule’s July 2, 2018 implementation date. Continue Reading

CNDA Releases New Rules on the Inspection of Medical Device Clinical Trials for Comment

Last month, the China Nation Drug Administration (CNDA, formerly known as China Food and Drug Administration or CFDA), released a draft rule on Inspection Key Points and Guiding Principles of Medical Device Clinical Trials (“New Draft”). This is the third draft rule related to medical device clinical trial inspections that CNDA has issued in the last two years. The draft rules cover site inspections by CNDA, which began in 2016, of clinical trials for devices that are in the process of product registration. The purpose of the inspections is to evaluate the compliance of these trials with good clinical practices (GCP) and ensure data integrity, which has been a significant concern for CNDA in the drug and device spaces. The drafts refer to the inspections as assessing “authenticity” and “compliance.” Continue Reading

Gottlieb Sees “Vast Potential” Ahead for Digital Health

Advancing digital health technologies is one of FDA’s strategic priorities for 2018.  FDA’s Center for Devices and Radiological Health (CDRH) has traditionally taken a leading role in establishing FDA’s regulatory policies toward digital health technologies, and recent FDA announcements on digital health indicate that CDRH will continue efforts to develop new agency approaches toward digital health.  In a recent post on our Digital Health blog, Covington’s Digital Health team described the FDA’s latest announcements. Key updates include: Continue Reading

CMS Finalizes Medicare National Coverage for Diagnostic Next Generation Sequencing Tests

On March 16, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Determination (NCD) for Next Generation Sequencing (NGS) as a diagnostic laboratory test for patients with certain advanced stages of cancer. The NCD process was initiated by Foundation Medicine, Inc.’s request for Medicare coverage for its FoundationOne CDx test, the first FDA companion diagnostic that can detect genetic mutations in solid tumors. The NCD provides for Medicare coverage of NGS tests that have been FDA-approved or cleared as a companion diagnostic for patients with certain stage III or IV cancers. In addition, the NCD delegates authority to Medicare Administrative Contractors (MACs) to determine local coverage for tests that do not meet the NCD’s FDA criteria.

Holding a key role in the area of precision medicine, NGS is the second technology, and also the second category of vitro laboratory tests, to have successfully completed the FDA-CMS Parallel Review Program. The first in vitro diagnostic to be approved and covered under the Parallel Review Program was Cologuard®, a multi-target sDNA colorectal cancer screening test for which CMS finalized a NCD in October 2014. The Parallel Program was designed to reduce the time between FDA approvals and Medicare national coverage and, here, CMS issued its proposed NCD determination on November 30, 2017, the same date that FDA extended approval for the FoundationOne CDx test and within six months of the FDA’s receipt of the product application. Continue Reading

CFDA and CMDE Issue Draft Guidance on Medical Devices for Rare Diseases

On February 6, 2018, the China Food and Drug Administration (CFDA) and its Center for Medical Device Evaluation (CMDE) issued a draft guidance entitled “Guidance on the Review of Medical Devices for Preventing and Treating Rare Diseases.” The draft guidance is based on the reform measures recently outlined in the government’s broad blueprint for drug and device reform—the Opinion on Strengthening the Reform of the Drug and Medical Device Review and Approval Process to Encourage Drug and Medical Device Innovation (“Opinion 42”)(See our prior alert here).

The draft guidance provides regulatory expectations for medical device companies to conduct preclinical studies and clinical trials for medical devices intended to prevent or treat rare diseases, i.e., orphan medical devices. The draft guidance also proposes expedited programs for orphan medical devices, including a conditional approval program and a possible exemption from clinical trials, which were previously outlined in the Opinion 42.

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