On July 28, 2014, FDA issued an important final guidance relating to the Agency’s substantive review of 510(k) notifications, entitled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” This guidance applies to the 510(k) review process for both diagnostic and therapeutic devices and is applicable to 510(k) reviews undertaken by the Center for Biologics Evaluation and Research (CBER) as well as the Center for Devices and Radiological Health (CDRH). Although FDA notes that this guidance is “not intended to implement significant policy changes,” the guidance clarifies and addresses many key issues in the 510(k) program. FDA describes in detail the Agency’s critical decision points in the 510(k) review process and updates the 510(k) review flowchart that was first introduced in 1986. This guidance also discusses key concepts in the 510(k) program, such as the difference between “indications for use” and “intended use,” the use of multiple predicates, and requests for clinical data.
On July 14, 2014, FDA publicly posted its response denying Public Citizen’s August 2011 citizen petition concerning the marketing of non-absorbable surgical mesh products for transvaginal repair of pelvic organ prolapse (POP). In its response, FDA took the position that a ban or recall of POP devices is not warranted at this time.
As background, in August 2011, Public Citizen filed a citizen petition asserting that POP devices “offer no clinically significant benefits in comparison to surgical repairs for POP performed without placement of surgical mesh” and “have high rates of serious complications.” Public Citizen requested that the agency take the following actions: (1) ban the marketing of all available non-absorbable surgical mesh products for transvaginal repair of POP; (2) order all manufacturers to recall these products; and (3) classify all new non-absorbable surgical mesh products for transvaginal repair of POP as class III devices and approve the products only under a premarket approval application (PMA).
The China Food and Drug Administration (CFDA) issued a Notice on Items Related to Class I Medical Device Notifications (Notice) to establish new notification procedures for Class I medical devices, which includes in vitro diagnostics. This Notice is one of several that CFDA issued at the end of May 2014 related to the implementation of its recently completely revised Medical Device Supervision and Administration Regulation (MDR), which became effective on June 1, 2014.
On July 15, 2014, FDA issued a draft guidance entitled “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics,” which describes the benefit and risk factors that FDA may consider during the review process for a 510(k) submission (“draft guidance”). This draft guidance applies to both diagnostic and therapeutic devices. FDA makes clear at the outset that the draft guidance is not intended to change the 510(k) premarket review standard or impose extra burden on a 510(k) submitter to provide additional performance data.
Recently, the United States Food and Drug Administration (FDA) released two long-awaited draft guidance documents pertaining to internet and social media:
- Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
- Internet/Social Media Platforms with Character Space Limitations–Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.
The first draft guidance outlines FDA’s current thinking concerning how manufacturers of drugs, biological products, and medical devices should respond to misinformation about their products posted by third parties on internet/social media platforms. FDA recognizes that information created by third parties is not always accurate and may be “dangerous or harmful to public health.” Therefore, the guidance provides firms various methods to correct such misinformation.
On June 20, 2014, FDA issued a draft guidance entitled “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,” informing manufacturers and others “that the Agency does not intend to enforce compliance with the regulatory controls” that apply to these three types of devices.
Medical device data systems (MDDS), medical image storage devices, and medical image communications devices have been regulated as Class I, 510(k)-exempt devices. Although exempt from premarket review, they have been subject to other FDA regulatory requirements. In addition, the 510(k) exemption was subject to certain limitations (21 CFR 880.9 & 892.9), including premarket notification for MDDS intended to be used in a system assessing the risk of cardiovascular disease or in diabetes management.
On June 1, 2014, the newly revised Medical Device Supervision and Administration Regulations (revised MDR) took effect. The revised MDR has changed medical device regulation in China significantly (described here), but some of the revised provisions conflict with implementing rules for the prior MDR that are still legally effective. Although the China Food and Drug Administration (CFDA) has released proposed revised drafts of many of these implementing rules, none have been finalized. Approximately one week prior to the effective date of the revised MDR, CFDA released a Notice on Issues Related to the Implementation of the MDR (Notice) which is intended to resolve some of these conflicts.
Medical device manufacturers that sell their products to the U.S. government may soon be required to implement programs for the detection and reporting of counterfeit or nonconforming end items and parts. On June 10, 2014, the Federal Acquisition Regulatory (FAR) Council issued a proposed rule that would require government contractors to report to the Government-Industry Data Exchange Program (GIDEP) the use and delivery of counterfeit items, suspect counterfeit items, and major or critical nonconforming items that have multiple applications in contractors’ work, and that suppliers provided to contractors and other customers with nonconformances that were not detected by the suppliers’ internal quality control systems. The proposed rule would also require contractors to report counterfeit and suspect counterfeit items to contracting officers when the items were purchased for delivery to the U.S. Government, regardless of whether contractors actually deliver or intend to deliver the items. In addition, the proposed rule would require contractors periodically to screen reports submitted to GIDEP in an effort to avoid using or delivering counterfeit, suspect counterfeit, or nonconforming items. The proposed rule applies to contracts for commercial and commercially available off-the-shelf items, which implicates medical devices sold on the Department of Veterans Affairs’ medical equipment supply schedule or otherwise sold to government purchasers.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on software as a medical device, including apps. The guidance aims to assist those working in healthcare, and software developers, to determine whether a specific piece of stand-alone software or an app constitutes a medical device. The MHRA provides illustrative examples of software, specifically apps, that are considered to be medical devices, a summary of the current regulatory device regime, in particular its application to systems, and advice on how to comply with the necessary regulatory requirements.
The guidance defines stand-alone software (also known as software as a medical device) as “software which has a medical purpose which at the time of it being placed onto the market is not incorporated into a medical device.” The definition is similar to that agreed recently by the International Medical Device Regulators Forum (see our previous post). The MHRA makes clear that software, including apps, that have a medical purpose and meet the definition of medical device in the Medical Devices Directive will be regulated by the MHRA as devices and will have to undergo a conformity assessment.
The guidance states that decision support or decision making apps are most likely to be considered as medical devices by the MHRA. That is, apps that apply some form of automated reasoning, such as a simple calculation, a decision support algorithm or a more complex series of calculations e.g., dose calculations, symptom tracking, clinicians guide. This includes software which provides personalised guidance based on information the app has about a specific individual and makes use of data entered by them, provided by point of care devices or obtained via health records.
The MHRA clarifies that a key determination in assessing whether an app is a medical device is if a healthcare professional is likely to rely on the output of the app and not review the raw/source data. If an app only provides information to assist a healthcare professional make a clinical decision based on their own knowledge the software may not be considered a medical device.
Software used to interpret or interpolate patient data stored on a server via a remote point of care patient monitor is likely to be a medical device.
Individual medical devices must be CE marked, but the MHRA does not require each component of a system, such as a telehealth system, to be CE marked as a medical device unless they are placed on the market as a single product. For example, items such as the hub and possibly the remote monitor (depending on the claims of the manufacturer) do not have a medical purpose and therefore may not be CE marked. However, the Medical Devices Directive requires the whole system to be safe. This is particularly pertinent to stand alone software, where the manufacturer must demonstrate compatibility with the recommended hardware platforms. In cases where the system incorporates components which do not bear a CE marking or where the chosen combination of components is not compatible in view of their manufacturer’s original intended use, the system will be treated as a device in its own right.
Last week, FDA launched openFDA—its new, open government initiative. Created in response to an executive order on transparency, openFDA will provide access to many of the agency’s health data sets. FDA is encouraging developers of websites and mobile medical apps to process FDA’s health data so it is more useful for the public, clinicians, and researchers.
On June 2, 2014, the agency published a database with millions of drug adverse event reports—the first step for openFDA. While adverse event report records were previously available under the Freedom of Information Act (FOIA) or by downloading large amounts of encoded files, the process of obtaining them can be slow and difficult. The openFDA database makes the adverse event reports easier to access and search using an Application Program Interface (API). “OpenFDA will make our publicly available data accessible in a structured, computer-readable format,” wrote Taha Kass-Hout, Chief Health Informatics Officer of FDA, in an openFDA blog post.
FDA’s hope is that pharmaceutical companies, researchers, and software developers will use this information about adverse events to identify emerging public health concerns. FDA has stated that it will not release any data that could be used to identify individuals or reveal other private information.
Software developers and mobile app developers might have new opportunities to process and package the information in ways that consumers can use and understand. For example, developers could create a mobile medical app that allows consumers to learn whether other users of a drug have suffered the same adverse events. (For information about how FDA regulates mobile medical apps, see our e-alert from September on FDA’s final mobile medical app guidance.)
OpenFDA’s adverse event datasets could be mined for numerous types of uses. Drug companies will have easier access to adverse event statistics. Consumers could obtain more information about adverse events occurring with drugs they are taking or might take. Lawyers might mine the dataset for use in lawsuits involving adverse effects of prescription drugs. The pharmaceutical industry is said to be “cautiously supportive” of the openFDA initiative, but urges that patients should receive information about a medicine in the context of both the benefits and the risks.
In the next few months, FDA expects to release additional information to openFDA, including records related to product labels and recalls of all FDA-regulated products, including medical devices. We will continue to follow the evolution of openFDA.