Tag Archives: Medical Devices

Proposed 21st Century Cures Act Addresses Off-Label Promotion Issues for Drugs and Devices

Over on the Health Industry Washington Watch blog, Reed Smith attorneys Katie Pawlitz and Jeremy Alexander highlight the proposed changes to the Sunshine Act contained within H.R. 6, the “21st Century Cures Act,” which (as previously reported on Life Sciences Legal Update) was approved by the House Energy and Commerce Committee last Thursday, May 21, … Continue Reading

FDA Releases Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Abroad

The Food and Drug Administration (FDA) has issued a notice announcing the availability of a draft guidance document clarifying its acceptance of medical device clinical data from studies conducted in countries other than the United States. The document is intended to provide guidance regarding the 2012 Food and Drug Administration Safety and Innovation Act § 1123, amending Food, Drug & Cosmetic Act § 569B, which codified FDA's policy of accepting scientifically-valid clinical data obtained from non-U.S. clinical studies in support of premarket submissions for medical devices.… Continue Reading

Erroneous Country of Origin Determinations May Result in Significant FCA Penalties for Medical Device Companies

Country of origin labeling issues can be exceedingly complex, as we have noted before. Several manufacturers have recently paid multi-million dollar settlements for alleged misstatements about their products’ country of origin, under the Trade Agreements Act (TAA) and False Claims Act (FCA). As described by Reed Smith attorneys Larry Sher, Larry Block and Jeffrey Orenstein … Continue Reading

FDA Draft Guidance Addresses Electronic Informed Consent in Clinical Investigations

FDA has issued a draft guidance providing recommendations for clinical investigators, sponsors and institutional review boards on the use of electronic informed consent for FDA-regulated clinical investigations of medical products, including drugs, medical devices and biological products. FDA is accepting comments on the draft guidance until May 8, 2015. In addition, the HHS Office for Human Research Protections (OHRP) is considering whether to adopt the positions and recommendations proposed in this guidance for research regulated under the HHS protection of human subjects regulations and to issue a joint OHRP/FDA guidance document on this topic once the FDA's final guidance document has been developed.… Continue Reading

FDA Releases Planning Board’s Report on National Medical Device Postmarket Surveillance System

FDA has released the Medical Device Postmarket Surveillance System Planning Board’s report, Strengthening Patient Care: Building an Effective National Medical Device Surveillance System, which outlines recommended steps toward achieving the National Medical Device Postmarket Surveillance System (MDS) and strategies for implementation. For more information, see http://blogs.fda.gov/fdavoice/index.php/2015/02/moving-toward-a-national-medical-device-postmarket-surveillance-system/.… Continue Reading

3D Printing Raises Novel Questions About Potential Product Liability

Over on the Drug & Device Law blog, Reed Smith partner Jim Beck (aka "Bexis") offers his thoughts on the possible product liability implications of printing 3D medical devices. Specifically, Jim examines the question of what party (or parties) would be held liable as the manufacturer in a product liability case involving 3D printing. There are uncertainties surrounding each of the three primary parties who may be considered for liability: the hospital that owns the 3D printer used to produce medical devices; the manufacturer of the 3D printer; or the designer of the software used by the 3D printer to create the products. Jim's post discusses the current issues around naming each of those parties as the manufacturer, and concludes that - at least for the time being - 3D printing presents an unusual situation in which it is feasible that no entity qualifies as a "manufacturer" under the Restatements for strict liability. Additional legal issues like this will likely emerge as 3D printing's popularity continues to increase.… Continue Reading

U.S. Congressional Committees Address Drug And Device Approval

As mentioned on our Health Industry Washington Watch blog, committees in both the House of Representatives and Senate last week addressed the speed at which medical innovations are approved and available for patient use. The House Energy and Commerce Committee’s “21st Century Cures Act” discussion draft, released on January 27, 2015, is a wide-reaching bill … Continue Reading

FTC Offers Privacy and Security Guidance for Medical Devices in ‘Internet of Things’ Report

On January 27, the Federal Trade Commission (FTC) issued a 71-page Staff Report on privacy and security issues with the Internet of Things (IoT) - the growing ability of everyday devices to monitor and communicate information through the Internet. The Staff Report - which follows up on the FTC's public workshop over concerns with the IoT, as well as the FTC's first enforcement action brought in September 2013 - is especially relevant in the life sciences industry, which may see potentially revolutionary advances as a result of the IoT.… Continue Reading

Life Sciences and Health Care Industries Reap the Benefits of 3D Printing

This post was written by Colleen Davies and Lisa Baird. The past few years have seen 3D printing – a process that involves the creation of a three-dimensional object from a pre-conceived design – evolve from a futuristic idea into a multi-billion dollar business, and few industries have benefitted more from this technology than life … Continue Reading

Proposed Rule Re Submitting Clinical Trial Registration and Results, Including Adverse Event Information, To ClinicalTrials.gov Database

The National Institutes of Health has released a proposed rule designed to provide clarity on the requirements surrounding the submission of information to ClinicalTrials.gov, as mandated by the Food and Drug Administration Amendments Act of 2007. Among these requirements is the submission of summary results for clinical trials involving all pharmaceuticals, medical devices and biological products, regardless of whether they have been approved, licensed or cleared by the Food and Drug Administration. The rule also provides timetable restrictions for the registration of a clinical trial and submission of summary results, as well as guidelines for the reporting of adverse events.… Continue Reading

Recent Data Breaches Serve as Warning for Companies to Assess Their Cybersecurity Insurance Coverage

Earlier this week, numerous media outlets reported on the Russian crime ring which had managed to steal more pieces of Internet data than any other group of hackers in history – a whopping collection of at least 1.2 billion user name and password combinations and over 500 million email addresses. The magnitude of data that … Continue Reading

Was It Worth the Wait? – FDA Releases Two Social Media Guidance Documents for Drug/Device Industry

Earlier this week, the FDA issued two draft guidances on social media, and Reed Smith attorneys Colleen Davies, Celeste Letourneau, Kevin Madagan, and Jennifer Pike have written a client alert that analyzes them both in detail. The first guidance pertains to product claims and risk information on platforms like Twitter and sponsored links, and the second to correcting third party misinformation that appears in social media, such as in comments on a Facebook page or website. A key date to keep in mind is that the deadline for comments is September 16, 2014.… Continue Reading

China’s Medical Device Regulations Receive Notable Revisions

Significant Revisions to China’s Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 650) China’s State Council released its new Administrative Regulation on the Supervision and Administration of Medical Devices March 7, 2014, which will be effective June 1, 2014 (the New Regulation). The State Council Legislative Affairs Office worked more … Continue Reading

FDA’s Center for Devices and Radiological Health Publishes Draft Guidances on the Medical Device Premarket Approval Process

This post was written by Jillian W. Riley Earlier this week, FDA’s Center for Devices and Radiological Health (CDRH) published two separate draft guidance documents to advance the dual goals of FDA and industry to provide pathways for medical devices to reach the market quickly while ensuring the safety and efficacy of the product. The … Continue Reading

China Issues New Regulations Prohibiting Commercial Bribery in the Health Care Industry

This post was written by John Tan, Amy Yang, and Crystal Xu. In late December, China’s National Health and Family Planning Commission (NHFPC), the successor organization to the Ministry of Health, issued two sets of anti-corruption regulations for the health care industry: the 2013 Regulations on the Establishment of a Commercial Bribery Blacklist for the … Continue Reading

FDA Updates TSE and Mad Cow Disease Guidance for Medical Devices

FDA recently released a draft guidance entitled "Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)," which discusses the risks of transmitting various forms of transmissible spongiform encephalopathies, including Mad Cow Disease (found in cattle), scrapie (found in sheep), chronic waste disease (found in deer), and Creutzfeldt-Jakob Disease (found in humans). The guidance is applicable to all medical devices that contain or are exposed to animal-derived materials, with the exception of in vitro diagnostic devices.… Continue Reading

Long Delays Still Expected for TSRA License Applications

Reed Smith’s Global Regulatory Enforcement Law Blog recently featured a post about the U.S. Treasury Department’s Office of Foreign Assets Control’s review of applications filed under the Trade Sanctions Reform and Export Enhancement Act of 2000. Although restrictions on the export and re-export of some medical devices and medicines were lifted a year ago, license … Continue Reading

China’s Life Sciences Regulatory Crackdown: September 10 Update

The regulatory enforcement environment in China remains tense, as both the Chinese government and media bring new actions and allegations against life sciences manufacturers in both the pharmaceutical and device sectors. We are seeing: Increased attention to medical device sector Enforcement actions spreading to smaller cities Continued pressure on pharmaceutical sector Reports of misconduct by … Continue Reading

China: Life Sciences Regulatory Crackdown Spreads to Medical Device Sector

On August 15, 2013, the local Beijing office of the Ministry of Health (MOH) of the People's Republic of China announced (Chinese link) that it has started a three-month review of the use of high-value medical consumables and large-scale medical equipment in Beijing. In its announcement, the Beijing MOH noted that prior inspections of hospitals had found continuing problems with the misuse and overuse of medical devices to increase profits. The investigation is intended to strengthen hospitals' management of the use of medical devices and to regulate the use of high value medical consumables.… Continue Reading

OIG Views PODs As “Inherently Suspect” Under the Anti-Kickback Statute

Referencing what it deems a "proliferation" of physician-owned distributors (PODs), on March 26, 2013, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a Special Fraud Alert identifying significant concerns with such entities under federal anti-kickback principles.1 For purposes of the Alert, the OIG defines a POD as "any physician-owned entity that derives revenue from selling, or arranging for the sale of, implantable medical devices," including "physician-owned entities that purport to design or manufacture, typically under contractual arrangements, their own medical devices or instrumentation." Specifically, the OIG describes in somewhat unusual detail the multiple "attributes and practices" of PODs that the OIG believes "produce substantial fraud and abuse risk and pose dangers to patient safety." Notably, the Alert is focused on PODs that derive revenue from selling, or arranging for the sale of, implantable medical devices that are ordered by physician-owners for use in procedures that physician-owners "perform on their own patients at hospitals or ambulatory surgical centers (ASCs)." However, the OIG states that "the same principles would apply when evaluating arrangements involving other types of physician-owned entities."… Continue Reading
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