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Inside Medical Devices

Updates on Developments for Medical Devices from Covington & Burling LLP

CDRH Posts Planned Guidance Activity for FY 2016

Posted in FDA Device Regulation

On December 28, 2015, CDRH posted two lists of guidance documents that the Center intends to publish in FY 2016: the “A-list” of draft and final guidance documents that FDA “fully intends to publish,” and the “B-list” of draft and final guidance documents that FDA intends to publish “as resources permit.”  FDA agreed to publish these lists annually as part of the negotiations over the Medical Device User Fee Amendments of 2012.

Notably, the A-list includes finalizing the highly debated draft guidance document “Framework for Regulatory Oversight of Laboratory Developed Tests” issued in October 2014.

Many of the other final guidance documents on the A-list were published in draft last year, including:

  • General Wellness Products (draft published in January 2015)
  • Medical Device Accessories (draft published in January 2015)
  • Adaptive Design for Medical Device Clinical Studies (draft published in May 2015)
  • Incorporating Patient Preferences into Medical Devices Premarket Approvals, Humanitarian Device Exemptions, and De Novo Classifications (draft published in May 2015)
  • Benefit-Risk Factors to Consider when Reviewing IDE submissions (draft published in June 2015)
  • UDI Direct Marking (draft published in June 2015)

The A-list also includes a draft guidance document on 510(k) device modifications.  As we have previously discussed, FDA’s policy on when a new 510(k) must be submitted for a modification to a cleared device has a long history.  FDA’s current policy is described in a 1997 final guidance document.  A revised draft guidance document was issued in 2011 but was required to be withdrawn by section 604 of the Food and Drug Administration Safety and Innovation Act of 2012.  FDA subsequently held a public workshop on the issue in June 2013.

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CDRH Schedules January 2016 Cybersecurity Workshop

Posted in FDA Device Regulation

CDRH has scheduled a cybersecurity workshop entitled, “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity,” on January 20-21, 2016 (see here for the Federal Register announcement).

Background and Workshop Context

As we discussed in a previous blog post, cybersecurity vulnerability is an increasing concern as medical devices are becoming more connected to the Internet, hospital networks, and other medical devices. Cybersecurity vulnerabilities may result in device malfunction, interruption of healthcare services including treatment interventions, inappropriate access to patient information, and breached electronic health record data integrity.

In the Federal Register announcement for the workshop, FDA states protecting the Healthcare and Public Health (HPH) critical infrastructure from attack by strengthening cybersecurity is a “high priority” of the Federal Government. For example, two recent Executive Orders (here and here) address enhancing cybersecurity infrastructure and increasing cybersecurity information sharing. Additionally, Presidential Policy Directive 21 states that the Federal Government shall work with the private sector to manage risk and strengthen the security and resilience of critical infrastructure against cyber threats.

Given this context, FDA, other governmental agencies, and public/private partnerships have sought to address cybersecurity vulnerability in recent years. For example, last year, CDRH finalized its guidance for industry entitled, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” Also in 2014, the National Institute of Standards and Technology (NIST) published a voluntary, risk-based framework focusing on enhanced cybersecurity. According to FDA, the HPH sector has utilized the framework to help manage and limit cybersecurity risks.

Workshop Objectives

At the public workshop, CDRH hopes to address vulnerability management throughout the medical device total product lifecycle. According to the Federal Register announcement, vulnerability management includes: analyzing how a vulnerability may affect device functionality, evaluating the vulnerability effect across product types, and selecting temporary solutions that may be employed until a permanent fix can be implemented. Vulnerabilities can be identified by the device manufacturer or external entities, including healthcare facilities, researchers, and other sectors of critical infrastructure. Continue Reading

Congress Enacts 2-Year Moratorium on Medical Device Excise Tax

Posted in Federal Taxation

On December 18, President Obama signed into law the Consolidated Appropriations Act, 2016 (H.R. 2029), which includes a two-year moratorium on the medical device excise tax.  The 2.3 percent tax on sales of medical devices (except certain devices sold at retail) was enacted as part of the Affordable Care Act in 2010 and applied to device sales beginning on January 1, 2013.  Division Q, Section 174 of the Consolidated Appropriations Act, 2016 amends section 4191 of the Internal Revenue Code to exempt medical device sales during the period of January 1, 2016 to December 31, 2017.

Absent further legislative action, the tax will be automatically reinstated for medical device sales starting on January 1, 2018.  The Joint Committee on Taxation estimated the cost of halting the tax for 2016 and 2017 at $3.4 billion.

The 2-year moratorium follows several legislative attempts to eliminate or delay the medical device tax since its enactment in 2010.  For example, a budget reconciliation bill that would repeal many parts of the Affordable Care Act, including the medical device tax, passed in the Senate earlier this month after passing in the House in October.  And in June, the House passed a bill repealing the device tax, the Protect Medical Innovation Act of 2015, which was introduced by Representative Paulsen in January of this year.  See our previous coverage for additional legislative activity.

The Consolidated Appropriations Act, 2016 also includes appropriations for FDA for fiscal year 2016, under which the agency will receive $2.71 billion, $133 million more than the agency received in fiscal year 2015.  According to one analysis, CDRH will receive $323 million, up slightly from $321 million in 2015.

CFDA Restructures Medical Device Adverse Event Regulations

Posted in Device Regulation in China

Following a significant revision of its framework medical device regulation (see our alert, here), the China Food and Drug Administration (“CFDA”) and the National Health and Family Planning Commission (“NHFPC”) have released a proposed revision to the Administrative Measures on Monitoring Medical Device Adverse Events and Re-Evaluation (“proposed Measures”), which is the primary regulation for medical device adverse events.  The proposed Measures contain the requirements for reporting, evaluating, and remediating adverse events and serious adverse events for both imported and domestically manufactured devices in China.   The comment period closed on December 20th.  We describe some of the key points of the proposed Measures below.

The proposed Measures are a revision of a 2008 rule of the same name.  The proposed Measures contain a number of changes to the medical device adverse event reporting system, including

  • the addition of a new definition of serious adverse event (SAE),
  • a system of enhanced monitoring for certain devices, and
  • a set of detailed requirements and timelines for government agencies, manufacturers, distributors, and healthcare institutions to monitor, report on, and analyze adverse events.

This system will rely upon the coordination of government designated medical device adverse event monitoring technical institutions (“monitoring institution”) at the central, provincial, and municipal levels of government.  CFDA committed to expand these institutions in 2013 (see our earlier entry, here).

The proposed Measures divide all medical device adverse events into SAEs and “normal” adverse events.  The proposed measures do not change the existing broad definition of adverse event, which provides that a “medical device adverse event” refers to a “harmful event” in which an approved medical device, meeting quality standards and used under normal conditions, causes or could cause harm to the human body.

The proposed Measures set forth five circumstances in which an adverse event would constitute an SAE:  (1) the device causes death; (2) the device endangers human life; (3) the device results in permanent loss of a bodily function or permanent structural damage to the body; (4) the injury caused by the device requires medical intervention to prevent permanent damage; or (5) circumstances in which, due to a defect in the device, its usability, or other such problem, a device could lead to one of the other four circumstances.

The proposed Measures have more detailed reporting requirements than the 2008 rule.  The primary entities responsible for reporting SAEs are “use entities” (i.e., healthcare institutions), manufacturers and distributors.  Individuals may also report suspected adverse events.  For an SAE, a manufacturer or healthcare institution must report it through CFDA’s medical device adverse event monitoring information website, or if that is not possible, to a “local” monitoring institution using a paper form.  The manufacturer or healthcare institution must report the event within 15 days of its occurrence or of learning of its occurrence.  If the SAE causes death, a report must be submitted within five days.  For normal adverse events, the report must be submitted within 30 days.

In addition, both Chinese domestic medical device manufacturers that distribute their devices outside of China and foreign device manufacturers must report SAEs that occur abroad.  Foreign manufacturers must make those reports within 15 days of the event or of knowledge of the event.

Once reported, monitoring institutions at different levels of government (provincial and municipal) will evaluate those events and report to the provincial food and drug regulatory agency (for Class I and Class II devices) or the CFDA (for Class III and imported devices).  If CFDA or the provincial food and drug authorities determine that additional steps are necessary to control the event, then they will communicate that decision to local healthcare regulatory authorities.  It is not clear what “control” action the healthcare authorities might take in these instances.

Devices with frequent or more severe adverse events may be subject to enhanced monitoring.  In that case, provincial monitoring institutions must monitor the device according to a special plan determined by the provincial food and drug authorities.  Manufacturers are required to “actively gather” adverse event reports, conduct a risk analysis, and report the results to a monitoring institution in their municipality or province.

Devices with problematic records may also require re-evaluation.  Specifically, if reported adverse events raise questions about the safety or the effectiveness of the device, either the manufacturer or the provincial food and drug regulatory authorities can re-evaluate the device to determine necessary measures need to be taken to control those issues.

The proposed Measures also include a general section on “remediation.”  For example, manufacturers that know that their device could cause an adverse event shall make that clear in the package insert and “other accompanying documentation.”  When a manufacturer discovers a safety defect that could cause harm, it shall take “recall measures,” such as training, warnings, inspections, repairs, and relabeling and amendment of the package insert, software upgrades, replacement of the device and destruction.  If the event is determined to be the result of a medical accident, healthcare authorities must take steps to resolve the problem, although the proposed Measures do not include detail as to that process.

The proposed Measures impose penalties for failing to properly monitor or report adverse events, such as fines or, in more extreme cases, orders to stop production or cancel licenses.  The proposed Measures also state, however, that the content of adverse event reports and related risk analyses may not serve as the basis for disputes or litigation surrounding medical treatment or for resolving incidents related to medical device quality.

All device manufacturers that distribute their devices in China should continue to monitor the progress of this rule, and its implementation.

LDT Update: FDA and CMS Testify Before the House Energy & Commerce Subcommittee Following Year of Debate on Oversight of LDTs

Posted in FDA Device Regulation

On November 17, 2015, the House Energy & Commerce Subcommittee on Health held a hearing examining the regulation of laboratory developed tests (LDTs).  CMS Deputy Administrator Patrick Conway and CDRH Director Jeffrey Shuren testified regarding the respective roles of CMS and FDA in the oversight of LDTs.

The day before the hearing, FDA issued a report of 20 case studies that FDA provided in support of its proposal to regulate LDTs as devices.  FDA describes this report as illustrating “how lack of LDT oversight may be causing or is causing significant harm to patients.”

As previously reported, last October FDA published a draft guidance document describing its proposed new regulatory framework for oversight of LDTs (and a companion draft guidance document on notification and reporting for LDTs).  Publication of the draft guidance documents followed a statutorily-required 60-day notice to Congress.  At the recent hearing, Dr. Shuren stated that FDA hopes to finalize the guidance documents in 2016.

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OIG Work Plan Includes Review of FDA’s Oversight of Networked Devices

Posted in FDA Device Regulation, Medical Information Technology

Today we published a post on the Covington eHealth blog regarding the HHS Office of Inspector General’s (OIG) Work Plan for fiscal year 2016.   The post describes OIG’s plan to review FDA’s oversight of medical devices networked to electronic medical records and hospital systems.

Recent Reports Claim Improvements in FDA’s Review of Medical Device Submissions

Posted in FDA Device Regulation

Two recent reports cite gains made by the Center for Devices and Radiological Health (CDRH) in strengthening the clinical trial enterprise and shortening the review times for marketing applications for medical devices.  The reports suggest that CDRH’s review processes are becoming more efficient, and that on average applicants can expect shorter review times for investigational device exemption (IDE) submissions, premarket approval (PMA) applications, and premarket notification (510(k)) applications, relative to years past.

In its 2014–2015 Strategic Priorities, CDRH announced that it intended to strengthen and streamline its review process related to clinical trials.  CDRH announced two specific goals to support this effort: (1) improve the efficiency, consistency, and predictability of the IDE process to reduce the time and number of cycles needed to reach appropriate IDE full approval for medical devices, in general, and for devices of public health importance, in particular; and (2) increase the number of early feasibility/first-in-human IDE studies submitted to FDA and conducted in the United States.  CDRH set various targets over the course of 2014 and 2015 to achieve these goals.

On September 24, 2015, CDRH issued an update on its progress.  Overall, CDRH claims to have met its clinical trial program goals.  For example, the report states that:

  • CDRH had reduced the number of IDEs requiring more than two cycles to an appropriate full approval decision by 53% compared to FY 2013 performance.  The goal had been a 50% reduction.  For FY 2015, 73.5% of IDE studies were fully approved within two cycles as compared to 14.8% in FY 2011.
  • CDRH had reduced the overall median time to full appropriate IDE approval to 30 days, meeting its goal.  In 2011, the median number of days to full IDE approval was 442 days.
  • CDRH had increased the number of early feasibility/first-in-human studies submitted to each premarket Division compared to FY 2013.  Specifically, there was a 50% increase in the number of early feasibility study submissions, and a 100% increase in the number of approvals, for the first nine months of FY 2015 compared to FY 2013.

CDRH discussed these and other improvements to its clinical trial program in a blog post (see here).

Also, on October 15, 2015, the California Life Sciences Association and Boston Consulting Group—with cooperation from FDA—released an infographic report titled “Recent Trends in FDA Medical Device Regulation.”  The report addresses trending data about the medical device review process over the last fifteen years, including PMA review times, 510(k) decision times, and variation in performance across CDRH’s review divisions and branches.  The report found that:

  • PMA average review times have declined steadily since FY 2010, with the exception of FY 2013 when there was a notable uptick in the percentage of devices referred for panel review (36% in 2013 versus 8% in 2012).  PMA average review times for FY 2014 are likely to reach their shortest time since 2000.
  • Although they are still above historic averages, 510(k) decision times have decreased over the last three fiscal years and the backlog has decreased.
  • While previously review division and branches varied significantly in meeting MDUFA PMA and 510(k) performance goals, recent overall performance improvements have also resulted in more consistent performance across the Center.

These reports suggest that CDRH has made strides in improving its IDE and marketing application review processes over recent years.  If sustained, these efforts should improve the predictability and timeliness of FDA reviews of medical device submissions going forward.

FDA’s Office of Planning Issues Report on Review Process for Combination Products

Posted in FDA Device Regulation

The pace and process used by FDA for the review of combination products has been the subject of considerable concern by many device companies.  On October 14, 2015, FDA’s Office of Planning issued a report summarizing a study of the intercenter consultation process for the agency’s review of combination products.  The report identifies several challenges faced by FDA staff in reviewing combination products and makes recommendations for addressing the issues identified by the study.

As noted in the report, FDA initiated the study last year following concerns expressed by industry regarding the consistency and clarity of FDA’s communications related to combination product reviews, including in a 2014 industry survey.  Consultations between agency centers during review of combination products are currently governed by internal procedures that were last updated in 2004.

The purpose of the study was twofold: (1) to “examine coordination within FDA for consulting across agency centers, including management, timing, timeliness, and workload challenges,” and (2) to “investigate interactions between applicants and FDA around combination product applications.”  The study team conducted focus group discussions within CDRH and CDER and interviewed agency employees in leadership positions and key roles related to the review of combination products.  The study team obtained input from industry representatives on issues faced by industry prior to developing the questions posed to focus group participants and interviewees.

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FDA CDRH Announces Regulatory Science Priorities for FY 2016

Posted in FDA Device Regulation

Yesterday we published a post on the Covington eHealth blog regarding the FDA Center for Devices and Radiological Health (CDRH) Regulatory Science Priorities for FY 2016.  The post describes CDRH’s top ten regulatory science priorities with a particular focus on those related to leveraging Big Data and health information technology to inform regulatory decision making.

EU Agreement on a General Approach on the Medical Devices Package

Posted in Device Regulation in Europe

On October 5, 2015, after three years of continued discussions and negotiations on the modernization of EU medical devices and IVD rules, the Council of Ministers of the EU countries (“the Council”) agreed on a full General Approach on the review of the medical devices and IVD framework. The European Commission considers this as “a major step forward towards the adoption of new regulations on medical devices to help guarantee a high level of health and safety protection for EU citizens using these products.”

This agreement is based on the technical work of the Permanent Representatives Committee of EU countries which finalized the Council’s position on the draft Medical Devices and IVD Regulations on September 23, 2015. The core substance of the Council’s position was already agreed in a partial General Approach on the draft EU medical devices package on June 19, 2015 (for details please see our previous post of early September). The final agreement of October 2015 does not deviate from the substance of that partial agreement of June 2015. The main difference is that it includes a general approach on the recitals of the draft Regulations on medical devices and IVD. Preambles of EU legislative instruments do not have a binding effect; however, they are useful in the interpretation of rules and usually consulted by EU and Member State institutions and courts in their application of the law.

For example, as we noted earlier in our September post, the Council’s General Approach does include clarifications on companion diagnostics in the recitals of the draft IVD Regulation, which will be useful in the application of the relevant rules in the future. The compromise text of those recitals is slightly different from the one adopted back in February 2015 and is as follows:

“ (11a) Companion diagnostics are essential to define patients’ eligibility to specific treatment with a medicinal product through the quantitative or qualitative determination of specific markers identifying subjects at higher risk of developing adverse reaction to the specific medicinal product or identifying patients in the population for whom the therapeutic product has been adequately studied, and found safe and effective. Such biomarker(s) may be present in healthy subjects and/or in patients.”

“(11b) It should be clarified that devices monitoring the response to treatment by the corresponding medicinal product for the purpose of adjusting treatment to achieve improved safety or effectiveness of that corresponding medicinal product are considered companion diagnostics. Devices that are used in treatment drug monitoring to ensure that the drug concentration in the human body is within the therapeutic window of the drug are not considered companion diagnostics.”

The final agreement on the Council’s General Approach of October 2015 will enable the Council to initiate the “trilogue” discussions with the European Parliament and the European Commission. The aim is to reach an agreement for the adoption of the new Regulations as soon as possible, in theory even before end of 2015; a more realistic prediction, however, would be to have an agreement sometime in 2016.

Please note that the draft Regulations include transitional periods for application of their rules. The Medical Devices Regulation will apply three years after its entry into force and the IVD Regulation will apply five years after entry into force. Devices which comply with the new rules may be placed on the market even during the transitional periods.

It is important to note, however, that the application of the new framework will have an impact on devices that are already on the market on the basis of the currently in force Directives 90/385/EEC (Active Implantable Devices Directive), 93/42/EEC (Medical Devices Directive) and 98/79/EC (IVD Directive).  E.g., based on the draft Medical Devices Regulation, devices that have been lawfully placed on the market before its date of application may continue to be made available only until five years after that date.  Similarly, the new framework will also affect the validity of certificates issued by notified bodies before and after the entry into force of the Medical Devices Regulation.

The full texts of the General Approach are available online at: