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The medical device market is expanding into more private healthcare products in hopes of bringing healthcare directly to the user. For example, the increase in popularity of wearable diagnostic devices, such as FitBit,...more
The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices.
In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement...more
The U.S. Food and Drug Administration (FDA) recently announced its tougher new requirements for testing reusable medical devices. ...more
The US Food and Drug Administration (FDA) issued a final guidance document on March 12 titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” Although the final guidance was expected...more
This Week: Senate HELP Committee Hosts Hearing on Medical Innovation... HHS Announces Next Generation Accountable Care Organization (ACO) Model... CBO Releases New Long-range Cost Estimates for ACA....more
On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials. eICs have the potential to...more
At the Food and Drug Administration’s Center for Devices and Radiological Health, the new year started off with an approval of the first therapeutic weight loss option for obese patients since 2007....more
Between January 20 and February 9, 2015, the U.S. Food and Drug Administration (“FDA”) issued four guidances related to its policies toward low risk devices. These guidances were largely developed as an outgrowth from FDA’s...more
FY 2016 budget request reflects FDA’s broadening scope of activities -
The regulator’s requested budget of $4.9 billion for the upcoming fiscal year represents a 9% increase from the enacted FY 2015 budget, with $147.7...more
Safeguarding, streamlining, strengthening the clinical trial process is one of three of the Food and Drug Administration’s primary goals for 2015. So states an 11-page document titled 2014 – 2015 Strategic Priorities....more
Today’s newsflash: winning is good. Winning is better than losing. Winning at trial is especially good. Winning at trial enhances the chance of winning on appeal. But are there ways to win at trial that improve the odds...more
The U.S. Food and Drug Administration (“FDA”) recently issued guidance on an array of medical device-related software and systems. A first guidance for ”Data Systems and Imaging Devices” issued on February 9, 2015, and...more
In a wide-ranging speech on Tuesday, Securities and Exchange Commission Director of Enforcement Andrew Ceresney discussed recent SEC actions and current concerns involving the pharmaceutical and medical technology industries....more
Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate. In one of these...more
For those familiar with the television show Star Trek, many may remember the Tricorder, a device that Dr. “Bones” McCoy used to wirelessly scan a patient to assess the individual’s medical status.
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...more
Last Thursday the genetic diagnostic and DNA analysis company 23andMe announced that the FDA had granted the company approval to market a genetic diagnostic test for Bloom's Syndrome, the first such approval for this rare...more
23andMe is not a traditional diagnostics company. Rather than seeking to directly sell its services to health care professionals, 23andMe went straight to the consumer, offering genetic screening and analysis in a mail-order...more
Accessories are an everyday reality for almost all users of technology products today. They can help improve efficacy, increase usability and make many other improvements to the technology we use. Increasingly, accessories...more
On February 09, 2015, the FDA issued final guidelines to outline its regulatory enforcement approach to mobile medical applications (or “apps”). The FDA is taking a risk-based approach, focusing its oversight on apps that...more
Day Two of the open GPhA Annual Meeting featured a panel on FDA and industry perspectives on a quality culture. Janet Woodcock, M.D., Center Director, Center for Drug Evaluation and Research (CDER) provided the agency’s new...more
The Food and Drug Administration (FDA) on February 6th, finalized guidance on certain medical devices that store and transfer data, opting for a very light regulatory touch. In its guidance, the FDA states that it doesn't...more
EPA OEI Office Announces Transfer Of TRI Program To OPPT: On January 22, 2015, U.S. Environmental Protection Agency (EPA) Office of Environmental Information (OEI) announced that EPA has begun the process of transferring the...more
The House of Representatives and the Senate are assessing significant reforms to the Food, Drug and Cosmetic Act. The reforms are aimed at accelerating the approval of new drugs, medical devices and other products regulated...more
The other day we read a thoughtful Bloomberg piece on 3D printing in the medical device context by a trio of Alston & Bird litigators. We’ve given you the link, but it might be behind a paywall.
The article indicates...more
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