Category Archives: Medical Devices

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FDA Releases 2018 Roadmap: Focus On Digital Health Continues

Last week, FDA released a document outlining its policy priorities for the coming year. “Healthy Innovation, Safer Families: FDA’s 2018 Strategic Roadmap” addresses continued focus on digital health, among other priorities, as one way that the agency seeks to further its public health mission and foster innovation that benefits consumers and patients.  Consistent with this … Continue Reading

H.R. 3985 Calls For Public-Private Working Group to Study Medical Device Security

The “Internet of Medical Things Resiliency Partnership Act of 2017” was introduced in the House of Representative earlier this month.  Co-sponsored by Rep. David Trott (R-MI) and Rep. Susan Brooks (R-IN), the bill would require establishment of “a working group of public and private entities to develop recommendations for voluntary frameworks and guidelines to increase … Continue Reading

Digital Health Update: Tech and Health Care Giants Selected for FDA’s Pre-Cert Program

In his keynote address at the AdvaMed annual conference in late September, FDA Commissioner Scott Gottlieb returned to the themes of promoting innovation by partnering with industry.  Consistent with that, and furthering the agency’s emphasis on digital health innovation, he announced the companies that will be participating in FDA’s Pre-Cert program, a program that the … Continue Reading

FDA Extends Risk-Based Medical App Approach to Medical Device Data Systems in New Guidance

The recent release of two guidance documents addressing current FDA enforcement policies for medical devices that are Medical Device Data Systems (MDDS) and mobile applications (mobile apps), provide further evidence that when it comes to health IT products, FDA’s policy aims to keep unnecessary FDA regulation from impeding the progress of new technologies that offer … Continue Reading

U.S.-China Commission Study Provides Policy Recommendations to Help U.S. Exporters Compete in China’s Growing Medical Device and Pharmaceutical Market

A recent report issued by the U.S.-China Economic and Security Review Commission (USCC)[1] highlights why the Chinese market is central to the business strategy of many U.S. companies that manufacture and market pharmaceuticals, medical devices, and other healthcare products.  The Congressionally-mandated report[2], issued in November 2014, addresses in detail the opportunities and challenges surrounding access to … Continue Reading

FDA Releases Social Media Guidance for Promotion of Prescription Drug and Medical Device Products

Recently, FDA released two draft guidance documents on the promotion of prescription drugs and medical devices on the Internet and social media platforms.  The long-awaited guidance provides recommendations for firms that choose to correct misinformation disseminated by independent third parties and to promote their products on space-constrained platforms, such as Twitter or sponsored ads.  Comments … Continue Reading

FDA Announces Final Rule Banning BPA from Infant Formula Packaging

The Food and Drug Administration (“FDA”) announced last week the publication of a final rule banning bisphenol-A (“BPA”) from use in infant formula packaging – a decision made based on proof of industry abandonment rather than safety concerns. In July 2012, then-U.S. Representative Edward J. Markey filed a food additive petition seeking to amend the … Continue Reading

Handy Health Tracking Mobile App…Or Regulated Medical Device?

The use of mobile apps for health purposes has created new questions for users, developers, and regulators regarding the balance between convenience, expanded health care, and public safety. The line between apps that are useful tools for accessing health information and those that are considered medical devices can be unclear but is very important for … Continue Reading

DHHS and FDA Officials Respond to Medical Device Mobile Application Regulatory Concerns on Final Day of Hearings

The House Subcommittee on Oversight and Investigations concluded a three-day series of hearings regarding medical device mobile applications (“MMAs”) on Thursday morning. Our posts regarding the first two hearings are here and here. The focus of day three was to hear testimony from key FDA and DHHS officials who have responsibilities relating to MMAs and … Continue Reading

Day 2 of Medical Device Mobile App Hearings Focuses on Patient Benefits

The Health Subcommittee of the House of Representatives Energy and Commerce Committee held a second day of hearings regarding medical device mobile applications (“MMAs”) on Wednesday. Our post regarding the first day of hearings can be found here. The focus of day two was “Health Information Technologies: How Innovation Benefits Patients.” The subcommittee heard from … Continue Reading

House Subcommittee Holds Day 1 of Hearings on Medical Device Mobile Apps

The Communications and Technology subcommittee of the House of Representatives Energy and Commerce Committee held its first day of a three-day series of hearings regarding medical device mobile applications (“MMAs”) on Tuesday. The topic of Tuesday’s hearing was “Health Information Technologies: Harnessing Wireless Innovation.” Subcommittee chairman Walden (R-OR) set the stage for the hearing by … Continue Reading

House Energy and Commerce Committee To Hold Hearings on Regulation of Medical Device Mobile Applications

The House of Representatives Committee on Energy and Commerce (the “Committee”) is set to hold a three-day series of hearings next week regarding regulation of medical device mobile applications. The hearings follow a March 1, 2013 letter from the Committee to Food and Drug Administration (“FDA”) Commissioner Dr. Margaret Hamburg. In the letter, the Committee … Continue Reading

There’s an App For That: FDA Clears iPhone iExaminer App

FDA recently granted clearance to a new telemedicine product – the Welch Allyn iExaminer – which, when used in conjunction with the iPhone, allows users to capture, send, store, and receive high resolution images of the eye. According to the manufacturer’s 510(k) submission, the iExaminer is cleared for prescription use only and is intended to … Continue Reading

California Court Allows State Law Claims Against Medtronic to Proceed; Rejects Preemption Argument

The Superior Court for the County of Los Angeles ruled earlier this week in Cabana v. Stryker Biotech, LLC that a products liability action arising out of the off-label use of Medtronic’s INFUSE Bone Graft medical device could proceed by rejecting Medtronic’s summary judgment motion. Medtronic had argued that plaintiff’s claims were both expressly and impliedly … Continue Reading

FDA Provides Draft Guidance on Refuse to Accept Policy for 510(k)s to Replace Existing Guidances

FDA released yesterday a draft guidance entitled, “Refuse to Accept Policy for 510(k)s,” that seeks to clarify and ultimately replace existing policy documents explaining when a medical device premarket notification (510(k)) submission is administratively complete and ready for substantive review. The draft guidance comes after last month’s third renewal of the Medical Device User Fee … Continue Reading

FDA Proposed Rule Would Place New Labeling and Reporting Requirements on Medical Device Manufacturers

On July 10, 2012, the Food and Drug Administration (“FDA”) published a proposed rule implementing Federal Food, Drug, and Cosmetic Act (“FD&C Act”) provisions establishing a unique device identification system for medical devices over the next seven years. The rule would require medical device manufacturers—including a specification developer, a single-use device reprocessor, a convenience kit … Continue Reading

Where in the World is FDA? FDA Submits Report to Congress on Foreign Programs as Required by FSMA

The Food and Drug Administration (“FDA”) has submitted its Report to Congress on the FDA Foreign Offices. Under the Food Safety Modernization Act (FSMA), FDA is required to update Congress on the agency’s progress in establishing foreign posts and working with foreign government counterparts to further FDA’s mission. Companies that import food, drugs, devices or … Continue Reading

Fourth Circuit Clarifies Scope of Federal Preemption for Requirements Governing Medical Devices

The United States Court of Appeals for the Fourth Circuit recently affirmed a West Virginia federal district court’s holding that a plaintiff’s common law tort claim was preempted by the 1976 Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”). Under the MDA, certain medical devices, known as Class III devices, are … Continue Reading

FTC Mobile App Enforcement: Mobile App’s Acne Treatment Claims Require 2 Clinical Studies

Yesterday, the Federal Trade Commission (“FTC”) approved a final settlement with marketers of the “Acne Pwner” and “AcneApp” mobile applications (“apps”). This is the first FTC settlement targeting health claims by mobile app developers/marketers, but one of several FTC mobile app enforcement actions. In the AcneApp case, the defendants claimed that their apps could treat … Continue Reading

FDA Notice Clarifies Past Federal Preemption Policy Statements

The Food and Drug Administration (“FDA”) recently completed an evaluation of the legal basis for federal preemption policy statements the agency has issued under the Federal Food, Drug & Cosmetic Act (“FDCA”) during the past 10 years. FDA initiated the review in response to a memorandum issued by President Obama in May 2009 which directed … Continue Reading

FDA to Host Public Workshop on Mobile Medical Apps Guidance

The FDA announced that it will host a public workshop on September 12th and 13th, 2011 to gather input on the agency’s recently issued draft guidance document, “Mobile Medical Applications.” The FDA issued the guidance last month to inform manufacturers, distributors, and other stakeholders about how the FDA intends to apply its medical device regulatory … Continue Reading

Hold the Tweets: Why Marketers of Consumer Health Products Should Watch For FDA’s Policy on Social Media

The Food and Drug Administration (FDA) is expected to issue guidance and possibly regulations regarding use of social media. These policies will only be enforceable on marketers of prescription drugs and restricted medical devices; however, industry can expect that the rationale and policy behind the guidance and regulations will apply across the board to consumer … Continue Reading

Can We Say That? A Practical Guide to Substantiating Claims for Food and Consumer Health Products

This Monograph, published by the Food and Drug Law Institute, is designed to assist lawyers, regulatory advisors and marketing professionals answer the question “Can we say that?” as they design and execute programs to promote consumer health products such as foods, dietary supplements, non-prescription drugs and medical devices, cosmetics and pet care products. It serves … Continue Reading

Settlement with Indoor Tanning Association Regarding Claims Characterizing Disease Risks for Tanning and Vitamin D Supplements

This post was written by Sarah Roller. On May 19, 2010, the Federal Trade Commission (FTC) approved a final settlement order with the Indoor Tanning Association charging that the association exaggerated the health benefits of indoor tanning and misrepresented that indoor tanning increases the risk of skin cancer. The settlement bars the Association from making … Continue Reading