Header graphic for print

Inside Medical Devices

Updates on Developments for Medical Devices from Covington & Burling LLP

HHS Launches Portal Seeking Questions from Mobile Health Application Developers

Posted in mobile medical apps, Privacy

On October 5, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services launched a new platform to enable developers of mobile health technology, as well as others “interested in the intersection of health information technology and HIPAA privacy protection.” OCR notes that there is currently “an explosion of technology using data about the health of individuals in innovative ways to improve health outcomes.” The platform allows for individuals to both submit and review questions on the HIPAA implications of these mobile health applications.

The platform invites mobile health developers to submit questions and topics for future guidance. The portal asks:

What current provisions leave you scratching your heads? How should this guidance look in order to make it more understandable, more accessible? Use this page to submit your questions about HIPAA. Or present a use case. Look at what your peers are discussing, comment on it and vote on which topics or use cases would be the most helpful or important to your work.

As of now, the platform features questions (though no answers yet) regarding:

  • what entities are covered by HIPAA;
  • the application of HIPAA to cloud computing;
  • what aspects of the application (environment) must be HIPAA compliant;
  • the content of business associate agreements;
  • the flow of patient-generated data; and
  • the use of audit logging by developers.

Anyone can browse the site, but users who wish to submit questions must register. Registered users may also offer comments on other submissions or vote on the relevance of a topic. The portal represents that the entities and email addresses associated with posts by registered users will be anonymous to OCR. OCR also states that posting or commenting on a question on the portal will not subject anyone to enforcement action. While OCR will moderate comments posted by users, it will not vouch for the accuracy of these comments. Thus, users must pay close attention as to whether guidance appearing on by the portal is endorsed by OCR before taking action in reliance on this guidance.

The release of the portal comes at a time of particular uncertainty for medical application developers. HHS has acknowledged that existing HIPAA guidance has not addressed all of the questions raised by emerging technologies and has said that it plans to seek guidance from mobile application developers themselves. Depending on the timeliness of, and level of detail contained in, OCR’s responses to questions, the portal could prove a useful resource to a quickly evolving industry.

FDA Proposes Amending the Definition of “Intended Use”

Posted in FDA Device Regulation

On September 24, 2015, FDA published a proposed rule that, if finalized, would amend the agency’s regulations defining “intended use” for drugs and devices.  Given the central role that  “intended use” plays in FDA’s regulatory system, we regard this as an important development.


The concept of “intended use” has long served as a fundamental tenet of FDA’s regulatory system.  The intended use of a product determines whether it meets the definition of a drug, device, or other regulated product under the Federal Food, Drug, and Cosmetic Act (FDCA) and thus may be regulated by FDA.  Intended use also gives rise to the concept of off-label use or promotion.  For example, most medical devices are approved or cleared for a particular intended use described in that product’s labeling.  If evidence demonstrates that the manufacturer’s actual intended use is different than the approved or cleared use, this can result in the product becoming misbranded, triggering civil or criminal penalties.  Therefore, one of the most critical questions in FDA law is how intended use is defined.  What evidence should be considered when defining the intended use for a drug or device?

Both the drug and device regulations broadly define intended use.  The current regulation for devices, 21 C.F.R. § 801.4, states:

The words intended uses or words of similar import … refer to the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the devices, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. But if a manufacturer knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with such other uses to which the article is to be put.

This regulation (as with the counterpart drug regulation, 21 C.F.R. § 201.128) has long posed interpretive challenges.  For example, the regulation defines intended use according to the “objective intent” of the manufacturer as expressed in promotional activity of the manufacturer, but then suggests that other evidence, such as how the product is actually used by physicians/consumers, can also determine intended use.  With very limited exceptions (in cases with unusual facts), courts have determined “intended use” by reference to the claims used by manufacturer to promote its products.  For example, as stated by the Fourth Circuit, “no court has ever found that a product is ‘intended for use’ … within the meaning of the FDCA absent manufacturer claims as to that product’s use.”  Brown & Williamson Tobacco Corp. v. FDA, 153 F.3d 155, 163 (4th Cir. 1998), aff’d, 529 U.S. 120 (2000), but see U.S. v. Travia, 180 F. Supp. 2d 115 (2001).

FDA’s Proposed Rule

FDA’s proposed regulation arises out of its regulation of tobacco products.  The proposed rule primarily addresses the circumstances when a tobacco product would be considered to have an intended use that triggers regulation as a drug or device.  The preamble, however, more broadly addresses the concept of intended use.  FDA continues to assert that intended use can be determined broadly, stating that “[i]n the context of medical products, generally, circumstantial evidence often ensures that FDA is able to hold accountable firms that attempt to evade FDA medical product regulation by avoiding making express claims about their products.”  However, FDA “would not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on the firm’s knowledge that such product was being prescribed or used by doctors for such use.”

The primary change to both the drug and device intended use regulation would be to strike the last sentence of the regulation (“But if a manufacturer knows ….”).  According to FDA:

[T]he Agency does not regard a firm 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 doctors for such use.  Accordingly, FDA is taking this opportunity to amend §§ 201.128 and 801.4 to better reflect FDA’s interpretation and application of these regulations. These changes would not reflect a change in FDA’s approach regarding evidence of intended use for drugs and devices. These clarifying changes to the intended use regulations would apply to drugs and devices generally, and not just to products made or derived from tobacco and intended for human consumption.

If finalized, these changes would clarify aspects of FDA’s approach to assessing the intended use of a drug or device.  But given the importance of this concept and the lack of clarity on how intended use is determined, drug and device companies should review FDA’s proposal and consider submitting comments to the docket on ways in which FDA could further clarify its policies.  The agency will accept comments until November 24, 2015.

CDRH Schedules Next Generation Sequencing Workshops

Posted in FDA Device Regulation

CDRH has scheduled two next generation sequencing (NGS) workshops on November 12 and 13, 2015 (see here and here for the Federal Register announcements) to further advance the conversation with stakeholders on the Agency’s development of new regulatory strategies for NGS-based clinical tests.  These workshops will build upon a discussion paper published in December 2014, which we summarized in a previous blog post, and a public workshop with stakeholders held earlier this year.

As we discussed in our previous blog post, NGS refers to technologies that can perform sequencing of large segments of an individual’s DNA, and even the individual’s entire genome.  NGS tests pose regulatory challenges to FDA, because they can “generate large amounts of data and consequently may have relatively broad or undefined intended uses or indications.”  79 Fed. Reg. 78092, 78093 (Dec. 29, 2014).  The agency states in a blog post that FDA seeks “to ensure that these tests provide accurate, reproducible, and meaningful results relevant to a person’s medical condition while continuing to foster innovation so that people have access to the best available results generated by the most cutting-edge medical technologies.”

The first of the two workshops held in November will focus on obtaining feedback on “possible analytical standards and approaches to develop or build on existing standardization efforts in order to optimize FDA’s regulatory approach to NGS-based in vitro diagnostic tests.”  The second workshop will address current challenges in clinical validation of NGS tests.  According to FDA’s blog post, the workshop will discuss how scientists, patient groups, and private industry can work together to develop “high-quality, curated clinical databases of genomic information that associate specific genetic changes with various diseases.”

FDA plans to publish additional discussion papers in advance of these two workshops.  These papers will include general questions for stakeholder consideration and also provide a “high level overview” of regulatory considerations for the two issues to be covered by the workshops.  We will provide updates when the two papers are published.

The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests Convenes its Inaugural Meeting

Posted in Uncategorized

On August 26, 2015, the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (hereinafter the “Panel”) held its inaugural meeting.  The Panel was established by the Secretary of Health and Human Services under the authority of Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”), which prescribes a new market-based payment system for laboratory tests paid under the Clinical Laboratory Fee Schedule.  PAMA directs the Secretary to consult with the expert outside advisory Panel for (1) input on the establishment of payment rates under the new law for new clinical diagnostic laboratory tests, including whether to use crosswalking or gapfilling processes to determine payment for a specific new test, (2) input on the factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests, and (3) recommendations under the new law.  See Charter for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Test.

The 16-member Panel is chaired by Centers for Medicare & Medicaid Services (“CMS”)  Medical Officer Steve Phurrough.  A full list of the panel members can be found here.

The August Panel meeting occurred in advance of CMS’s implementation of the PAMA payment system, yet the Panel discussed new test codes for 2016, voting to make recommendations on codes relating to molecular pathology, drug of abuse testing, and other areas previously discussed at the Annual Laboratory Public Meeting held in July.  The Panel heard from several presenters discussing these codes, which included representatives from the American Medical Association and the Association for Molecular Pathology.  A full list of the presenters can be found on CMS’s website.  The Panel also considered and made recommendations on requests for reconsideration of 2015 payment decisions.  CMS is expected to release its preliminary decisions for 2016 by the end of September.

With the first Panel meeting now complete, the pathology and laboratory communities continue to wait for CMS to publish regulations implementing PAMA’s new mandates.  The regulations will likely also provide additional information on the scope of the Panel’s role in addressing coverage and payment processes under the market-based pricing system.  Although PAMA required  a final rule to be released by June 30, 2015, CMS has missed the deadline.  CMS announced at the meeting that the proposed rule is almost completed and should be issued in the next several weeks.  The proposed rule has been received by the Office of Management and Budget and can be tracked here.

IVD Regulation and Companion Diagnostics – EU Council Dramatically Changes Definition

Posted in Device Regulation in Europe

On June 19th, 2015, the Council of EU Ministers reached a partial General Approach on the review of the medical devices and in vitro medical devices (IVD) rules in the EU (an overview of the texts is accessible here).  The General Approach does not yet include the recitals to the new medical devices and IVD regulations.

The Council’s text on the new IVD Regulation significantly amends the Commission’s proposed definition of ‘companion diagnostics’, an evolution relevant to sponsors of both medicinal products and diagnostic devices.  The Council’s definition of companion diagnostics is almost identical to the definition used by the FDA, but significantly different from the European Commission’s proposal and the European Parliament’s suggested amendments.  An overview is set out below.   Continue Reading

Multistakeholder Group Seeks Comment on Draft Framework for IoT Device Manufactures

Posted in Privacy

Last week, our colleague Libbie Canter published a post on a draft framework for Internet of Things (IoT) device manufacturers.  This post describes the Online Trust Alliance’s draft framework for best practices for IoT manufacturers and developers, such as connected home devices and wearable fitness and health technologies.  The OTA is seeking comments on its draft framework by September 14.

Cybersecurity Risks with Connected Devices

Posted in FDA Device Regulation

Cybersecurity vulnerability is becoming an increasing concern as medical devices are becoming more connected to the Internet, hospital networks, and other medical devices. As we previously reported, FDA has increasingly focused on promoting cybersecurity, recognizing that compromised medical devices can pose a risk to patient health and safety and to the confidentiality of personal medical information. In addition, the National Institute of Standards and Technology (NIST) has recently provided a draft practice guide for securing health records maintained on mobile devices. Continue Reading

FY 2016 Medical Device User Fees Announced

Posted in FDA Device Regulation

On August 3, 2015, the FDA announced the medical device user fee rates and payment procedures for fiscal year (“FY”) 2016, which applies from October 1, 2015 through September 30, 2016. The Agency will raise user fee rates by over 4%.

Under the Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device User Fee Amendments of 2012 (“MDUFA III”), FDA is authorized to collect user fees for certain medical device submissions as well as annual fees for periodic reports of class III devices and registration for certain establishments. A qualified applicant may pay a lower “small business” fee; however, there is no reduction in the establishment registration fee for small businesses. FDA’s announcement and guidance, “FY 2016 Medical Device User Fee Small Business Qualification and Certification,” also issued on August 3, contains information on how to qualify as a small business for the purposes of medical device user fees. Additionally, FDA’s announcement includes information concerning the procedures for paying fees.

The fee rate for each submission type is based upon a specified percentage of the standard fee for a premarket application (“PMA”). The following are the FY 2016 standard user fees:

  • PMA: $261,388
  • Panel-track supplement: $196,041
  • 180-day supplement: $39,208
  • Real-time supplement: $18,297
  • 510(k) premarket notification submission: $5,228
  • 30-day notice: $4,182
  • 513(g) request for classification information: $3,529
  • Annual fee for periodic reporting on a class III device: $9,149
  • Annual establishment registration fee: $3,845

Continue Reading

Bill Introduced to Streamline and Clarify Combination Product Regulatory Process

Posted in FDA Device Regulation

Sen. Johnny Isakson (R-Ga.) introduced a bi-partisan bill (S. 1767) on July 15, 2015, to help streamline and clarify the FDA regulatory process for combination products.  Co-sponsored by Sens. Robert Casey (D-Pa.) and Pat Roberts (R-Kan.), the “Combination Product Regulatory Fairness Act of 2015” is, according to Roberts, intended to “clarify the regulatory process for innovative treatments that do not easily fit into the current categories of FDA approval.” Continue Reading

21st Century Cures Act Passes the House: Contains Key Provisions Related to Medical Devices

Posted in FDA Device Regulation, mobile medical apps

The 21st Century Cures Act (“the Act”) was passed by the U.S. House of Representatives on July 10, 2015, by a vote of 344-77. The Act includes provisions that would significantly affect the regulation of pharmaceuticals, biological products, and medical devices. We previously summarized the medical device provisions of a discussion draft of the Act that was circulated in January 2015 (see here).

The device provisions of the Act have been subject to many revisions since the discussion draft, including (i) the deletion of a placeholder for laboratory developed tests (LDTs), (ii) deletion of sections related to research use only products and surrogate endpoint qualification and utilization; and (iii) significant changes to the section relating to FDA authority over certain software.

If enacted, the Act would make changes to the standards and process for premarket review of new devices, the regulation of health software, and a number of other key medical device topics.

The Senate is currently working on parallel legislation to the Act. In addition, if not enacted during this Congress, it is possible that many aspects of the proposed legislation will be incorporated in the reauthorization of the Medical Device User Fee Amendments and associated legislation in 2017. We will continue to report on these legislative proposals as they are considered by the Senate.

To read more about these proposed changes to medical device regulation and other features of the Act, see our recent alert.