FDA Publishes Two Draft Guidances on Next Generation Sequencing Technology

FDA recently published two draft guidance documents related to the development of devices that utilize next generation sequencing (NGS) technologies. These two draft guidances support the Administration’s Precision Medicine Initiative (PMI), which is intended to promote technologies that use genetic, environmental, and other data to tailor health care tools to unique needs of individual patients.  FDA had previously held public workshops addressing NGS technology in February and November 2015.  According to FDA, when finalized, the guidance documents “will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person’s genomic makeup.” Continue Reading

District Court Opinion Provides Guidance for Extensions of Medical Device Patents Containing Method Claims

Last month, the Eastern District of Virginia held that a patent covering a medical device may not be eligible for an extension unless the patent “claim[s] the use of the particular product that underwent FDA review.”  The case serves as an important reminder that, for purposes of securing a patent term extension, applicants claiming methods of using a medical device should try to draft claims that particularly recite features of the device for which U.S. Food and Drug Administration (FDA) review is anticipated.  Although not controlling law, the district court decision presents an interesting analysis of patent term extension eligibility for medical device patents containing method claims.  A copy of the court decision can be accessed here.

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Impact of Brexit on EU Medical Devices Regulation and Structures

The UK recently voted to leave the European Union in an advisory referendum. The impact of Brexit on medical devices regulation in the medium-to-long term will very much depend on the form a post-Brexit UK will take, the relationship that the UK chooses to have with the EU, and indeed the relationship that the EU is willing to accept. That will not become clear for some time as it will likely take at least two years for the UK to negotiate an exit from the EU from the point when the UK notifies the EU of its intention to leave, which will not be until October 2016 at the earliest. In the short-term, however, from a legal perspective it is likely to be business as usual for the medical devices industry since EU law will continue to apply in the UK. Nevertheless, medical devices companies need to start considering what steps they should take to minimise impact and disruption if and when Brexit happens.

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FDA Releases Draft Guidance on Dissemination of Patient-Specific Information by Device Manufacturers

Last month, the FDA released a draft guidance document on the sharing of patient-specific data associated with medical devices, including information recorded, stored, processed, retrieved, and/or derived from the device.  FDA noted that patients increasingly seek to play an active role in their own health care and that providing patients access to information regarding medical products will empower patients to be more engaged with their healthcare providers in making medical decisions.

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CMS Publishes Final Rule to Implement PAMA’s Changes to Laboratory Test Reimbursement

Last week, the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register its long-awaited final rule implementing the significant payment and related changes for clinical diagnostic laboratory tests under the Medicare Clinical Laboratory Fee Schedule.  The changes were directed by the Protecting Access to Medicare Act of 2014 (“PAMA”), which establishes a new formula and process to set Medicare payment amounts at the weighted median of private payor rates.  Our client alert discussing the final rule’s key takeaways and the ways it differs from CMS’s proposed rule can be accessed here.

In its final rule, CMS delayed the PAMA-directed effective date by one year, until January 1, 2018.  The additional time was intended to help alleviate, among other things, administrative and other burdens on industry.  Payment updates will be calculated using private payor data from affected laboratories for a six-month collection period, beginning January 1 through June 30, 2016.  Data for the first update must be reported to CMS between January 1 and March 31, 2017 and CMS will release the new Medicare rates by November 2017.  The data collection and reporting time lines will be repeated every three years for most tests and every year for certain advanced tests.  Details on registration and reporting procedures, as well as other operational requirements, are forthcoming.  To ensure compliance, affected companies should begin preparations to understand and incorporate the complex regulatory criteria into their operations.

CFDA Releases New Self-Assessment Reporting Requirements for Medical Device Distributors

On June 7, 2016, the China Food and Drug Administration (“CFDA”) released the Notice on Regulating Distribution Activities in Medical Device Circulation (“Notice”). The Notice requires that distributors of Class II and III devices assess their compliance with Medical Device Good Supply Practices (“GSPs”) and other medical device regulations over the course of the last two years and submit a self-assessment to their municipal food and drug regulator by July 15, 2016. Continue Reading

FDA Releases Draft Guidance on the Use of EHRs in Clinical Investigations

On May 17, 2016, FDA issued draft guidance encouraging clinical investigators to make their electronic data capture (“EDC”) systems interoperable with health care organizations’ electronic health records (“EHRs”).  Although EHRs are generally under the control of health care organizations and institutions (not FDA-regulated entities such as sponsors), when records are used in clinical investigations, FDA has certain expectations about the source of data.  In its draft guidance, FDA addresses the use of EHRs and integrating the data to the EDC for agency decision-making purposes. Continue Reading

FDA Releases Draft Guidance on IDE Device Categorization to Assist CMS Coverage Decisionmaking

Last week, the FDA issued draft guidance modifying its current policy on categorizing Investigational Device Exemption (“IDE”) devices, in support of the Centers for Medicare & Medicaid Services’ (“CMS’s”) Medicare coverage decisions.  The guidance is intended to implement a Memorandum of Understanding (“MOU”) between the agencies to streamline and facilitate efficient categorization.  FDA requested that comments on the guidance be submitted by August 1, 2016 to be assured consideration before final guidance is issued. Continue Reading

CFDA Releases New Device Clinical Trial Exemption Catalogues for Comment

On May 20, 2016, the China Food and Drug Administration (“CFDA”) published drafts of two medical device clinical trial exemption catalogues on Class II and Class III devices for public comment (“CFDA Draft Catalogues”).  Comments are due on June 20, 2016.  This is the second round of clinical trial exemption catalogues since the revisions to the framework regulation, the Medical Device Supervision and Administration Regulation (“MDSAR”) was issued in 2014. Continue Reading

Obama Administration Releases Final Data Security Policy Principles and Framework for Its Precision Medicine Initiative

As the White House continues to build out the details for the Precision Medicine Initiative (“PMI”), on May 25, 2016 it released a final set of principles on data security.  In a document that “provides a broad framework for protecting participants’ data and resources in an appropriate and ethical manner,” eight overarching data security policy principles and a framework are outlined to guide PMI organizations in developing and implementing an organization-specific security plan.  These principles and framework are further described below.

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