FDA Holds Public Hearing and Seeks Comment on Draft Guidances Concerning Regulation of HCT/Ps

Last week, FDA held a two-day public hearing to obtain input on its four draft guidance documents concerning human cells, tissues, and cellular and tissue-based products (HCT/Ps). Our client alert, accessed here, summarizes each of the guidance documents, highlights significant areas of discussion during the public hearing, and provides insights on potential areas for further discussion with the agency. FDA is accepting comments on the HCT/P draft guidances until September 27, 2016. Continue Reading

CFDA Releases New Administrative Measures on Medical Device Recalls for Comment

The China Food and Drug Administration (CFDA) is expanding its reach over device recalls. In early September, CFDA released a long-awaited draft of the Administrative Measures on Medical Device Recalls (Proposed Rules).  These significantly-expanded measures would replace the current medical device recall rules that the Ministry of Health (now the National  Health and Family Planning Commission) released in 2011 (Current Rules).  Comments on the Proposed Rules are due on September 30, 2016. Continue Reading

Is Medical Software a Medical Device? European Court of Justice to Decide

On June 13, 2016, the French Conseil d’État (supreme administrative court) referred to the EU Court of Justice (“CJEU”), the question of whether medical software that provides support to healthcare professionals in prescribing medicinal products should be considered a medical device under Directive 93/42 (the “Directive”) (Case C-329/16).  The qualification of software as a medical device has important consequences and often depends on a complex and very facts-based assessment.  The CJEU’s ruling may help to clarify how to apply the existing regulatory criteria on the qualification and classification of software as a medical device.

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FDA to hold Public Hearing on Communicating Information about Off-Label Conditions of Use

Yesterday, FDA issued a Notice announced that it will be holding a 2-day public hearing on November 9-10, 2016 on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”

In the Notice, the agency explained that “FDA is engaged in a comprehensive review of its regulations and policies governing firms’ communications about unapproved uses of approved/cleared medical products, and the input from this meeting will inform FDA’s policy development in this area.” FDA provides some general discussion regarding the need to balance the potential benefits of allowing greater communication of relevant, truthful, and non-misleading scientific or medical information regarding unapproved uses of approved medical products, against the potential risks, the need for controls, and the need to preserve incentives for supplemental approvals.  Continue Reading

CFDA Proposes Priority Review Pathway for Certain “Breakthrough” Medical Devices

The China Food and Drug Administration (CFDA) recently released draft rules proposing a new priority review pathway of premarket submissions for certain medical devices with breakthrough technologies (Proposed Rules).  This priority pathway builds upon the State Council’s Opinion on Reform of the Drug and Medical Device Approval System (“Document No. 44”), which was released in August 2015.  Document No. 44 is a blueprint for the reform of drug and medical device review procedures and an effort to ensure that CFDA has an efficient procedure for approving medical devices that fill unmet medical needs.  Continue Reading

Federal Circuit Rules Device Patent Claims Not Limited by Specification Description, Not Invalid for Lack of Written Description

Earlier this month in ScriptPro LLC v. Innovation Associates, Inc., the Federal Circuit overturned a district court’s grant of summary judgment based on a lack of written description under 35 U.S.C. § 112. The device patent at issue, ScriptPro’s U.S. Patent No. 6,910,601 (“the’601 patent”), “is directed to a ‘collating unit’ used with a control center and an automatic dispensing system … to store prescription containers after a medication has been dispensed into containers.”  The district court determined that the “patent’s specification limits the invention to a collating unit that sorts and stores prescription containers by patient-identifying information and slot availability,” and that, therefore, the claims, which contained no such limitation, were invalid for lack of written description.

The Federal Circuit concluded that the specification does not limit the claimed invention to use of a collating unit that sorts and stores prescription containers by patient-identifying information. In reaching this conclusion, the Federal Circuit found several aspects of the intrinsic evidence persuasive. Continue Reading

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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