The United States Food and Drug Administration Medical Devices

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -
News & Analysis as of

Washington Healthcare Update

This Week: Health Subcommittee Advances 21st Century Cures, Full Committee Action Scheduled…Senate Finance Committee Hearing: Chair Hatch to Launch New Initiative on Improving Chronic Care for Medicare Patients…Hawaii’s...more

FDA Issues Guidance for Mobile Medical Apps

Just so you know, that iPhone or iPad you have with you may be an FDA-regulated medical device. More precisely, the apps on the device may meet the definition of a medical device under the Federal Food, Drug, and Cosmetic Act...more

St. Jude Medical Acquires Spinal Modulation, Inc.

St. Jude Medical recently announced that it has completed the acquisition of Spinal Modulation, Inc.  In June of 2013, St. Jude invested $40 million in Spinal Modulation for which it received an exclusive option (now...more

FDA Initiates Expedited Access Pathway Program for Medical Devices via Final Guidance Document

The U.S. Food and Drug Administration (FDA) initiated an Expedited Access Pathway (EAP) Program, effective April 15, 2015, for certain medical devices that are subject to premarket approval applications (PMAs) or de novo...more

New state law allows access to investigational drugs

In line with a nationwide movement, on April 21, 2015, Governor Fallin signed into law House Bill 1074, the Oklahoma Right to Try Act. The Act allows physicians to prescribe to terminally ill patients investigational drugs,...more

Medical Innovation: Congressional Committees Support Accelerated Research and Development for New Drugs, Devices and Biologics

Recent hearings by Senate and House committees and a scheduled markup underscore Congress' continued commitment to eliminating barriers that are slowing the development of effective drugs, devices, and biologics so that...more

FDA Regulatory and Compliance Monthly Recap – April 2015

In This Issue: - FDA issues guidance documents on how it considers balancing premarket and postmarket data collection during PMA reviews in a bid to accelerate the approval of new breakthrough devices - Guidance...more

Expedited Access Program Begins For Medical Devices

On April 15th, the U.S. Food and Drug Administration (FDA) began its Expedited Access Program (EAP), which is designed to get certain medical devices to market sooner. Under the EAP program, device sponsors collaborate...more

FDA Issues Draft Guidance Addressing Reliance on Ex-U.S. Clinical Data in Medical Device Premarket Submissions

On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of clinical data from trials conducted outside the United States (OUS) in support of...more

FDA Issues Draft Guidance Document on Acceptance of Foreign Medical Device Clinical Data

The FDA recently issued a draft guidance document regarding its policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices. In view of the...more

Washington Healthcare Update

This Week: Energy and Commerce Health Subcommittee Explores Post-Acute Bundling…CMS Releases First-ever Hospital Compare Star Ratings…Fiscal Year 2016 Proposed Inpatient and Long-term Care Hospital Policy and Payment Changes....more

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

On April 21, 2015, the Food and Drug Administration (FDA) issued a notice announcing the availability of a draft guidance document clarifying the Agency’s acceptance of medical device clinical data from studies conducted...more

You Should Know - April 2015

In This Issue: - Devices Go Awry - Protect Against Risks - Insiders Talk - Excerpt from Faulty Products Put Patients at Risk: Some Popular Medical Devices Escape FDA Scrutiny: Countless patients around the...more

PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA [Video]

The rise of social media has introduced new opportunities and new legal challenges for companies in the health care industry. Attorneys Seth Northrop and Sharon Roberg-Perez discuss the legal issues faced by care providers,...more

FDA Approves Expanded Use of Medtronic’s CoreValve System; Also Receives Regulatory Approval in Japan

Last week the U.S. Food and Drug Administration announced its approval of Medtronic’s CoreValve system for “valve-in-valve” (VIV) replacement. According to the FDA press release, this represents the first transcatheter aortic...more

Orthofix secures option to acquire eNeura for $65 million

On March 31, 2015, Orthofix International N.V. announced it entered into an 18-month option agreement to acquire eNeura, Inc. Orthofix’s website states that the focus of the company is on “improving patients’ lives by...more

Shift Labs Continues Trend Toward Consumer Wireless Healthcare Devices

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

Increased FTC Enforcement as FDA Deregulates Low-Risk Health IT Devices

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

FDA Issues New Rules for Testing of Reusable Medical Devices

The U.S. Food and Drug Administration (FDA) recently announced its tougher new requirements for testing reusable medical devices. ...more

FDA Issues Final Guidance on Reprocessing of Medical Devices

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

Washington Healthcare Update

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

New FDA Guidance Opens the Door for Electronic Consent Forms That Come with Significant Advantages and Raise Privacy and Secure...

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

Power to the Patients: FDA Employing New Methods for Medical Device Approvals

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

FDA's Evolving Policy Toward Health IT, Medical Apps, and Low Risk Devices

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

FDA Regulatory and Compliance Monthly Recap - February 2015

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

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