Medical Devices The United States Food and Drug Administration

News & Analysis as of

Preemption: Oregon Has Not Gone Bananas

Can you get sued over a picture of a banana? It seems the answer might depend on where you live and probably not in Oregon. That is one takeaway from a good preemption case that came out of the District of Oregon last week,...more

FDA Proposes Ban on Electrical Stimulation Devices for Aggressive or Self-Injurious Behavior

On April 25, the U.S. Food and Drug Administration published a proposed rule banning electrical stimulation devices (ESDs) used to treat aggressive or self-injurious behavior....more

C.D. Cal. Dismisses Infusion Pump Complaint

The plaintiff in Frere v. Medtronic, Inc., 2016 WL 1533524 (C.D. Cal. April 6, 2014), was an 80 year-old woman who had an infusion pump implanted to treat her chronic low-back pain. According to the plaintiff, the device...more

FDA Extends Comment Period on Third-Party Medical Device Servicing

As an update to my post on Friday, April 22, FDA has extended the deadline for comments on third-party servicing of medical devices. According to FDA’s notice of extension, comments are now due by June 3, 2016....more

FDA Still Seeking Manufacturer Views on Medical Device ISO Regulation

On March 4, 2016, the FDA issued notice in the Federal Register that it had opened a docket to accept comments on the agency’s proposed plan to address the refurbishing, remarketing, rebuilding, remanufacturing, and servicing...more

Mobile App Compliance for Dummies: New Tool Helps Developers Understand Their Legal Compliance Requirements

In a joint effort by the Federal Trade Commission (FTC), Office for Civil Rights (OCR), HHS Office of National Coordinator for Health Information Technology (ONC), and Food and Drug Administration (FDA), a new web-based tool...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...more

Settle or Fight FDA/DOJ Off-Label Use Allegations? WSJ Editorial Looks at Vascular Solutions Trial Win and Asks What's Next?

In an editorial this weekend entitled “No Justice for Business,” The Wall Street Journal hailed a recent trial win by medical device maker Vascular Solutions, Inc. (VSI) as a “victory for common sense and the First Amendment”...more

FDA Active on the Device Front for Q1 2016

Additional guidance documents are expected. The US Food and Drug Administration’s (FDA’s) first quarter of calendar-year 2016 has been a busy one on the medical device front. FDA’s Center for Devices and Radiological...more

FDA Medical Device Quality Inspections Drop in 2015

The U.S. Food & Drug Administration (FDA) has released statistics showing that it inspected fewer medical device manufacturers in 2015 than in 2014....more

Life Spine Announces FDA Clearance of PROLIFT Expandable Interbody System

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the PROLIFT Expandable Interbody System of Life Spine. Accordoing to its website, Life Spine is a medical device company based in Huntley, Ill.,...more

Heater-Cooler Devices Linked to Infections

Heater-cooler devices are used during cardiothoracic surgeries, and other medical and surgical procedures to warm or cool a patient. They include water tanks that provide temperature-controlled water to external heat...more

FDA Issues Draft Guidance on Medical Device Interoperability

On January 26, 2016, the FDA offered for public comment its draft guidance on medical devices and interoperability, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices—Draft...more

FDA Recalls Custom Ultrasonic

AERs (automatic endoscope reprocessor) are free-standing units used in health facilities to disinfect flexible endoscopes and scope accessories between uses. Custom Ultrasonic AERs should wash and high- level disinfect...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the Final Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage (MA) and...more

FDA Regulatory and Compliance Monthly Recap — March 2016

FDA warning letter calls out exoskeleton device manufacturer for repeatedly avoiding FDA requests for postmarketing surveillance - The FDA sent a warning letter to Argo Medical Technologies after the company averted...more

FDA Asks for Comments on Refurbishing and Servicing of Medical Devices

The Food and Drug Administration published a Proposed Rule in the Federal Register establishing a docket and requesting information and comments on third party entities that “refurbish, recondition, rebuild, remarket,...more

Senate Panel Approves Expedited Medical Device Review Bill

(March 11, 2016) The U.S. Senate Health, Education, Labor & Pensions committee approved a bill to expand an expedited review program for FDA approval of certain medical devices. The bill, S. 1077 “A bill to provide for...more

Box DICOM Viewer Cleared as Class II Medical Device

California-based Box Inc. announced recently that the FDA has cleared the company’s DICOM Viewer as a Class II Medical device. DICOM, which stands for Digital Imaging and Communications in Medicine, is the standard for the...more

Medical devices and cybersecurity: FDA calls for comprehensive risk management programs

The Food and Drug Administration (FDA), with the issuance of its recent 2016 Draft Guidance “Postmarket Management of Cybersecurity in Medical Devices,” continues to step up its involvement with medical devices having a...more

FDA Issues Draft Guidance for the Use of UHMWPE in Orthopedic Devices

On February 12, 2016, the FDA issued draft guidance for the use of ultrahigh molecular weight polyethylene (UHMWPE) in orthopedic devices. The draft guidance is open for public comment for the next 90 days. According to the...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

FDA Medical Device Safety Tracking System Reform

The Los Angeles Times reports that in recent years, several devices, including certain reusable medical scopes, metal-on-metal hip replacements, transvaginal meshes, and lead wires in heart defibrillators have been recalled. ...more

Senate HELP Committee Approves Additional Biomedical Innovation Bills

The Senate Health, Education, Labor and Pensions (HELP) Committee approved seven bills this month that are intended to promote biomedical innovation, building on legislation approved by the panel in February....more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more

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