Medical Devices The United States Food and Drug Administration

News & Analysis as of

Increased risk of ‘Medjacking’ calls for better security measures on medical devices

Did you know that right now we have about 5 billion connected smart devices in use? Is it surprising that it is predicted that by 2020 that number will skyrocket to 25 billion? Of all these connected devices, a significant...more

Bills Introduced to Streamline FDA Review of Medical Devices

U.S. Senators Cory Gardner (R-CO) and Joe Donnelly (D-IN) recently introduced the Rare Device Innovation Act and the FDA Regulatory Efficiency Act.  The bills, if passed, would streamline the U.S. Food and Drug Administration...more

Medical Devices a Target for Online Hackers

In the past few years, medical devices have become a major target for online criminals. Not only are medical devices considered to be one of the easiest and most vulnerable points of entry into a health care enterprise, they...more

Essure Medical Device Faces Attacks on Multiple Fronts

The threat of a hunger strike against the Food and Drug Administration, a Facebook page titled “Essure Problems Lawsuit” and a congressional bill calling for a recall of the female contraceptive manufactured by Bayer have...more

FDA Regulatory and Compliance Monthly Recap — October 2015

FDA releases draft ICH guidance with aim to improve pharmaceutical benefit-risk assessments - The agency released ICH guidance to regulate how pharmaceutical makers should present benefit-risk information in regulatory...more

GAO Report Regarding FDA-Ordered Postmarket Studies

On Octber 29, 2015, the General Accounting Office (GAO) released a report entitled “Medical Devices: FDA Ordered Postmarket Studies to Better Understand Safety Issues, and Many Studies Are Ongoing.” According to the report,...more

You Can Check Out Anytime You Want, But You Can Never Leave: FDA Import Detentions and Recommendations to Minimize Delays

In The Eagles’ song, “Hotel California,” Don Henley sings, “You can check out anytime you want, but you can never leave.” Life science companies can try to import all they want, but that doesn’t mean the products will make it...more

AdvaMed 2015 Highlights – Part One of Two

On October 5-7, 2015, the Advanced Medical Technology Association (“AdvaMed”) held its 40th Annual Meeting for the first time on the West Coast—San Diego, California. This year also signaled a change of AdvaMed’s membership...more

NuVasive Receives First-Ever 510(k) Clearance for a Cervical Corpectomy Cage

Spinal device specialist NuVasive recently received section 501(k) FDA clearance for its X-Core Mini Cervical Expandable VBR System, a titanium vertebral-body replacement device used in the cervical spine to replace vertebral...more

Government Finally Investigating Power Morcellators

Patients undergoing medical treatments expect that their physicians will utilize tools that will assist in the treatment without causing undue harm or damage to their bodies. One of these tools, a power morcellator which is...more

Wrap-Up of Federal and State Chemical Regulatory Developments, October 2015

On October 15, 2015, Bergeson & Campbell, P.C. (B&C®) and the Woodrow Wilson International Center for Scholars (Wilson Center) issued a report, "The DNA of the U.S. Regulatory System: Are We Getting It Right For Synthetic...more

Health Hackers: Problems in Applying Traditional Products Liability Theories to Latent Cyber-Vulnerabilities in Medical Devices

October is National Cyber Security Awareness Month (yes, that’s a thing), so it seems fitting to write about an unprecedented alert recently released by the FDA to health care providers that warned of a medical device’s...more

Plaintiffs Ask JPML to Transfer Power Morcellator Lawsuits to Kansas

Laparoscopic power morcellators are electronically powered tools that use a bladed feature to shred uterine fibroids and other tissue so that they may be easily removed through small incision in the abdomen. The process has...more

Washington Healthcare Update

On Oct. 8, the House Republican caucus did not select a candidate for Speaker of the House and selection has been delayed. The current Speaker, John Boehner (R-OH), had announced that he would step down and retire from...more

Pro Te: Solutio Vol. 8 No. 2

Summer is in full swing and certain topics are (staying) hot—especially regulatory issues, from new proposed rules to challenges to case law to strategic considerations. Generic preemption remains a hot topic. In Storm...more

Change Coming to FDA’s “Intended Use” Regulations?

Over at the Drug And Device Law Blog, our colleagues call attention to proposed changes to the “intended use” regulations for prescription drugs and devices, 21 C.F.R. §201.128 and 21 C.F.R. §804.1, somewhat hidden within a...more

The FDA Tiptoes – and Congress Splashes Into – the 21st Century

Here are a couple of non-litigation related matters that we thought our readers need to know about. First, the FDA. We’ve pointed out before that the FDA’s “intended use” regulations for drugs (21 C.F.R. §201.128) and...more

Making Sense of the Daubert and Summary Judgment Orders in A Metal-on-Metal Hip Implant Bellwether Case

We have not posted for a while—that day job can really get in the way sometimes—so we agreed to tackle the ridiculously long decision in Christiansen v. Wright Med. Tech. Inc., MDL No. 2329, 1:13-cv-297-WSD, 2015 U.S. Dist....more

FDA Detects That a Screening Tool for Early Detection of Cancer Types Might Require More Sleuthing

The Food and Drug Administration recently issued an untitled letter to a medical device company concerning its non-invasive blood test intended for use as a screening tool for the early detection of certain cancer types. FDA...more

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

FDA Establishes Patient Engagement Advisory Committee

The FDA recently announced establishment of the Patient Engagement Advisory Committee (PEAC). According to a notice published by the FDA, the PEAC will advise the Commissioner of the FDA, presently Dr. Stephen Ostroff, M.D.,...more

Dirty Instruments Pose Threat to Outpatients, Too

Earlier this year, both patients and providers were shocked when a rash of hospital patients got seriously ill or died after medical devices used to examine their gastrointestinal tracts infected them because they were not...more

In Case of Good Judge, Break Glass – Implied Impossibility Preemption in Cases Involving §510(k) Cleared Medical Devices

We have alluded on a couple of occasions to the likelihood that the recent generic drug implied impossibility preemption decisions in PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S....more

FDA Oversight of Diagnostic Medicine – A Trap for the Unwary

Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more

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