FDA Finalizes General Wellness Guidance

Last week FDA finalized a guidance document entitled “General Wellness: Policy for Low Risk Devices” in which the agency sets forth an approach to not regulate “general wellness products.”  This guidance document is important to the rapidly growing market for wellness products, which includes such things as activity trackers, smart watches, mobile apps, and other products intended to help monitor and improve consumers’ physical fitness, nutrition, or other similar goals.  FDA previously published a draft guidance in January 2015 on the same topic, which we blogged about here.  This post highlights key differences between FDA’s draft and final guidance.

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New EU Medical Device Guidance on Standalone Software

In a new post on the Covington eHealth blog, our colleagues provide an analysis of the European Commission’s updated guidance on when medical software will be deemed to be a medical device under EU law.  To read the post, please click here.

FY 2017 Medical Device User Fees Announced

On July 29, 2016, the FDA announced the medical device user fee rates and payment procedures for fiscal year (“FY”) 2017, which applies from October 1, 2016 through September 30, 2017. The FY 2017 user fees declined from the previous year’s rates.

Under the Federal Food, Drug, and Cosmetic Act (“FDCA”), 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.

FDA’s announcement describes the procedures to qualify as a small business. If a business has gross receipts or sales of no more than $100 million for the most recent tax year, the business may qualify for reduced “small business” fees.  However, there is no “small business” reduction in the establishment registration fee.  FDA’s announcement also includes information concerning the procedures for paying fees.

The fee rate for each submission type and for periodic reporting is based upon a specified percentage of the standard fee for a premarket application (“PMA”). The following are the FY 2017 standard user fees:

  • PMA: $234,495
  • Panel-track supplement: $175,871
  • 180-day supplement: $35,174
  • Real-time supplement: $16,415
  • 510(k) premarket notification submission: $4,690
  • 30-day notice: $3,752
  • 513(g) request for classification information: $3,166
  • Annual fee for periodic reporting on a class III device: $8,207
  • Annual establishment registration fee: $3,382

According to the Agency’s announcement, the fee you must pay is the fee that is in effect on the later of the date that your application is received by the Agency or the date your fee payment is recognized by the U.S. Treasury.

FDA Publishes Draft Guidance on Codevelopment of Companion Diagnostics

FDA recently published a draft guidance document titled “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product.”  A companion diagnostic is an in vitro diagnostic device that provides “information that is essential for the safe and effective use of a corresponding therapeutic product.”  The new draft guidance is intended by FDA as a “practical guide” to assist sponsors of therapeutic products and IVD companion diagnostics in the codevelopment process.

Companion diagnostics are a critical element of the advancement of precision medicine, a focus of FDA under the President Obama’s Precision Medicine Initiative, launched earlier this year.  There is increasing interest in identifying biomarkers that may be targets for therapeutic product development, prognostic indicators, or predictors of patient response to a particular therapy.  An estimated quarter of new drugs approved over the last two years were approved with a corresponding IVD companion diagnostic.  But codevelopment of IVD companion diagnostics and therapeutic products is often complicated by the fact that the products may be developed on different schedules, are subject to different regulatory requirements, and have different points of interaction with the appropriate review centers at FDA.  The draft guidance is intended to help sponsors and FDA reviewers navigate these challenges.

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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.

Click here to read the Alert

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

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