Last week, our colleague Libbie Canter published a post on a draft framework for Internet of Things (IoT) device manufacturers. This post describes the Online Trust Alliance’s draft framework for best practices for IoT manufacturers and developers, such as connected home devices and wearable fitness and health technologies. The OTA is seeking comments on its draft framework by September 14.
Cybersecurity vulnerability is becoming an increasing concern as medical devices are becoming more connected to the Internet, hospital networks, and other medical devices. As we previously reported, FDA has increasingly focused on promoting cybersecurity, recognizing that compromised medical devices can pose a risk to patient health and safety and to the confidentiality of personal medical information. In addition, the National Institute of Standards and Technology (NIST) has recently provided a draft practice guide for securing health records maintained on mobile devices. Continue Reading
On August 3, 2015, the FDA announced the medical device user fee rates and payment procedures for fiscal year (“FY”) 2016, which applies from October 1, 2015 through September 30, 2016. The Agency will raise user fee rates by over 4%.
Under the Federal Food, Drug, and Cosmetic Act, 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. A qualified applicant may pay a lower “small business” fee; however, there is no reduction in the establishment registration fee for small businesses. FDA’s announcement and guidance, “FY 2016 Medical Device User Fee Small Business Qualification and Certification,” also issued on August 3, contains information on how to qualify as a small business for the purposes of medical device user fees. Additionally, FDA’s announcement includes information concerning the procedures for paying fees.
The fee rate for each submission type is based upon a specified percentage of the standard fee for a premarket application (“PMA”). The following are the FY 2016 standard user fees:
- PMA: $261,388
- Panel-track supplement: $196,041
- 180-day supplement: $39,208
- Real-time supplement: $18,297
- 510(k) premarket notification submission: $5,228
- 30-day notice: $4,182
- 513(g) request for classification information: $3,529
- Annual fee for periodic reporting on a class III device: $9,149
- Annual establishment registration fee: $3,845
Sen. Johnny Isakson (R-Ga.) introduced a bi-partisan bill (S. 1767) on July 15, 2015, to help streamline and clarify the FDA regulatory process for combination products. Co-sponsored by Sens. Robert Casey (D-Pa.) and Pat Roberts (R-Kan.), the “Combination Product Regulatory Fairness Act of 2015” is, according to Roberts, intended to “clarify the regulatory process for innovative treatments that do not easily fit into the current categories of FDA approval.” Continue Reading
The 21st Century Cures Act (“the Act”) was passed by the U.S. House of Representatives on July 10, 2015, by a vote of 344-77. The Act includes provisions that would significantly affect the regulation of pharmaceuticals, biological products, and medical devices. We previously summarized the medical device provisions of a discussion draft of the Act that was circulated in January 2015 (see here).
The device provisions of the Act have been subject to many revisions since the discussion draft, including (i) the deletion of a placeholder for laboratory developed tests (LDTs), (ii) deletion of sections related to research use only products and surrogate endpoint qualification and utilization; and (iii) significant changes to the section relating to FDA authority over certain software.
If enacted, the Act would make changes to the standards and process for premarket review of new devices, the regulation of health software, and a number of other key medical device topics.
The Senate is currently working on parallel legislation to the Act. In addition, if not enacted during this Congress, it is possible that many aspects of the proposed legislation will be incorporated in the reauthorization of the Medical Device User Fee Amendments and associated legislation in 2017. We will continue to report on these legislative proposals as they are considered by the Senate.
To read more about these proposed changes to medical device regulation and other features of the Act, see our recent alert.
Bloomberg BNA reports (subscription required) that FDA will recognize a regulatory category called “complementary diagnostics” for tests that provide additional information about how a drug might be used, but that are distinct from “companion diagnostics,” which are essential for the safe and effective use of a drug.
It is becoming increasingly common for medical device companies to conduct clinical studies outside the United States and then seek to use data from these foreign studies in regulatory submissions to FDA. In a draft guidance issued on April 22, 2015, FDA lays out the factors it considers when confronted with data from foreign studies in premarket device submissions.
On March 9, FDA announced the availability of a draft guidance document focusing on the use of electronic informed consent (eIC) in clinical investigations. The document provides recommendations for investigators, sponsors, and institutional review boards (IRBs) concerning eIC, which refers to “using electronic systems and processes that may employ multiple electronic media (e.g., text, graphics, audio, video, podcasts and interactive Web sites, biological recognition devices, and card readers) to convey information related to the study and to obtain and document informed consent.” FDA issues this guidance at a time when the clinical research community is “showing greater interest” in using electronic media. Continue Reading
The China Food and Drug Administration (CFDA) has revised its good manufacturing practices (GMPs) for medical devices and taken steps to increase enforcement. These developments affect all medical device companies that have their own manufacturing facilities or use contract manufacturers in China.
A more detailed analysis of the impact of the work at the CJEU is featured in Clinica Medtech Intelligence.
Last week, a German court referred a liability case involving breast implants to the Court of Justice of the European Union (CJEU) to provide further clarity on the responsibilities and liability scheme for medical devices in the European Union. The key questions relate to the responsibility of the Notified Bodies, which are in charge of granting the CE mark that is required to place medical devices on the EU market. The CJEU’s answer will have an impact on the work of Notified Bodies in the EU and could also be relevant for the liability of medical device manufacturers in the EU.