2016 Year in Review: MDR Reporting Enforcement

In 2016, the Office of Compliance at the U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health issued a total of 17 warning letters to medical device manufacturers citing violations of its regulations under 21 C.F.R. Part 803 for adverse event and malfunction reporting and recordkeeping.  The 2016 warning letters inform current trends in reporting enforcement.

All but one warning letter (16 letters) cited violations of 21 C.F.R. 803.17, which describe the requirements for developing, maintaining, and implementing written medical device reporting (MDR) procedures.  Of the 16 letters, 7 letters determined that the company did not have a written procedure or plans to implement a written procedure that would satisfy the requirements of section 803.17.  The remainder (9 letters) described deficiencies with the manufacturer’s current procedures for MDR reporting.

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CDRH Releases Postmarket Cybersecurity Final Guidance

On December 28, 2016, CDRH announced the publication of the final guidance “Postmarket Management of Cybersecurity in Medical Devices.”  In a separate post, we reported on the January 22, 2016 draft version of this guidance document.  The final guidance provides FDA’s recommendations on a risk-based framework for medical device manufacturers to assess and remediate cybersecurity vulnerabilities.  The guidance also outlines circumstances in which the Agency intends to exercise enforcement discretion with respect to the requirements of 21 C.F.R. Part 806 to report actions related to cybersecurity vulnerabilities as device corrections and removals.

We highlight below key ways the final guidance document differs from the earlier draft version: Continue Reading

EU Medical Devices Regulation Series: Interpreting the “Industrial Scale” Concept

The term “industrial scale” appears twice in the draft EU Medical Devices Regulation (“MD Regulation”) in relation to so-called “in-house devices.” The term equally appears in the draft in-vitro diagnostic medical devices (“IVD”) Regulation.

To provide perspective on the meaning of “industrial scale” and how the draft MD Regulation’s use of the term may be interpreted, this post looks at two recent judgments pertaining to medicinal products before the EU Court of Justice: Joined Cases C-544/13 and C-545/13 Abcur (link here) and Case C-276/15 Hecht-Pharma (link here). Although there are evidently major differences between the medical device and medicines regulatory regimes, these judgments nevertheless provide useful guidance to interpret the notion “(non-)industrial scale” under the draft MD Regulation. Continue Reading

EU Expected to Amend RoHS2 Directive for Used and Refurbished Medical Devices

The European Commission is expected to present, in early 2017, a proposal to amend the RoHS2 Directive.  The amendment would remove the July 22, 2019 deadline for the supply and resale of non-compliant electronic medical devices, in-vitro diagnostic medical devices (IVDs) and monitoring and control instruments that were first marketed in, or imported into, the European Union or the European Economic Area (EU/EEA) before their RoHS2 cut-off dates.  If adopted, certain second-hand devices, as well as refurbished devices may continue to be marketed beyond 2019.

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CFDA Releases Draft Classification Catalogue of Medical Devices

The China Food and Drug Administration (CFDA) has recently released a long-anticipated draft Classification Catalogue of Medical Devices (Draft Catalogue). The Draft Catalogue updates a 2002 Classification Catalogue (Current Catalogue) and is one of the final pieces in the reform of China’s medical device system that has taken place since the 2014 revision of the framework regulation — the Medical Device Supervision and Administration Regulations (MDSAR).

Further indicating that this revision has become a priority and that finalization of the draft may come soon, just before the end of the comment period, on November 25, 2016, the CFDA convened a seminar of foreign and domestic manufacturers, health care professionals, and food and drug regulatory officials to discuss how to further improve the Draft Catalogue. Continue Reading

CMS Releases Instructions on PAMA Data Reporting

The Centers for Medicare & Medicaid Services (CMS) has now launched the new data reporting process for laboratories under the Protecting Access to Medicare Act (PAMA). Under CMS’s final PAMA rule, applicable laboratories must report private payor rates and other applicable information for certain clinical laboratory tests from a specified six-month data collection period. Additional technical information can be found on the CMS website, and in a slide presentation, available here. Continue Reading

Obama Administration Will Not Finalize LDT Framework Guidance

On November 18, 2016, the U.S. Food and Drug Administration (FDA or Agency) announced that it would not finalize the draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (Draft Guidance) prior to the end of the Obama administration.

As we previously reported, FDA issued the Draft Guidance on October 3, 2014.  The document describes the Agency’s shift from enforcement discretion policy for LDTs to a risk-based framework under which LDTs would be regulated as medical devices pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA).  In particular, the Draft Guidance outlined a phased-in approach for both premarket review and postmarket requirements, including registration and listing, medical device reporting, and Quality System Regulation (QSR) requirements.

Section 1143 of the Food and Drug Administration Safety and Innovation Act (FDASIA) required FDA to provide notification to Congress of its intent to finalize the Draft Guidance at least 60 days prior to the issuance of a final guidance. Although agency officials had stated that FDA would finalize the Draft Guidance by the end of 2016, the Agency had not provided this notification to Congress.  Had the Obama administration intended to move forward with a final guidance before the end of the administration, the notification required by FDASIA would had to have been issued by November 19, 2016.  At the same time, lawmakers had threatened to use the Congressional Review Act to block FDA from finalizing guidance documents imposing the FDCA on LDTs.

On Friday, an FDA spokesperson confirmed that the Agency would not finalize the Draft Guidance during the Obama administration:

“The FDA believes that patients and health care providers need accurate, reliable, and clinically valid tests to make good health care decisions — inaccurate or false test results can harm individual patients. We have been working to develop a new oversight policy for laboratory developed tests, one that balances patient protection with continued access and innovation, and realize just how important it is that we continue to work with stakeholders, our new Administration, and Congress to get our approach right. We plan to outline our view of an appropriate risk-based approach in the near future. It is our hope that such an approach will help guide continued discussions.”

We will continue to monitor legislative and regulatory developments relating to LDTs.

EU Medical Devices Regulation Series on Key Issues

It has been fairly quiet since the political agreement was reached last June on the EU Medical Devices Regulation (“the Regulation”). While the Commission’s lawyer-linguists iron out the final language, paving the way for formal adoption in the coming months, we are preparing a series of articles, beginning with this blog post, to address key aspects of the Regulation.

Comprised of around 100 provisions and extensive annexes, the Regulation contains dozens of topics that medical device professionals should be aware of. Our Medical Devices Regulation series will focus on select issues that we consider particularly noteworthy from a legal perspective. We would expect these issues to include the following topics:

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eHealth and mHealth Software Classification Changes in Forthcoming EU Medical Device Regulation

The new EU Medical Devices Regulation (MDR), a draft of which was tentatively agreed by the EU’s legislators on June 15, 2016, was revised at the last minute to include a new classification rule for software. Software’s classification under the MDR will determine its regulatory treatment (including what requirements it has to meet, and what regulatory approvals it must obtain).

The new rule is therefore relevant to companies and other organisations that sell clinical decision support or physiological monitoring software, including apps, that falls under the MDR’s reworked definitions of “medical device” or “accessory to a medical device.”

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CMDE Releases New Inquiry Rules on Medical Device Technical Review

On October 20, 2016, the Center for Medical Device Evaluation of China Food and Drug Administration (CMDE) released Guidance for the Management of Inquiry on Medical Device Technical Review (“New Guidance”).  The New Guidance replaces CMDE’s Guidance for the Management of Technical Inquiry on Registration of Medical Device (effective as of March 26, 2007, the “Prior Guidance”).   There are three major changes under the New Guidance: (i) The scope of these inquiries is narrower; (ii) In-person inquiries are limited to three times per application; and (iii) Two new inquiry channels were added—an online platform and “CMDE FAQs.” Continue Reading