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

Certain Medical Devices Exempted from 510(k) Requirements

The Food and Drug Administration (FDA) recently identified a list of Class II Medical Devices that, when finalized, will be exempt from premarket notification (510(k)) requirements. This publication was made by the FDA...more

AGG Food and Drug Newsletter - March 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

FDA to Exempt Over 1,000 Types of Medical Devices from Premarket Notification Requirements

On March 13, 2017, the U.S. Food and Drug Administration (FDA or the Agency) identified a list of 1,003 types of Class II medical devices that, when finalized, will be exempt from the Agency’s premarket notification (i.e.,...more

Pro Te: Solutio - Vol.9 No.3 – Fall 2016

The Fall 2016 issue of Pro Te is about all things regulatory, including a peek at the newly developing issue of crowdfunding for medical devices. In EMA Guidance on Clinical Data Publication, we discuss recent guidance...more

Outsourcing of Services in the Medical Device Industry

As the medical device market continues to grow, the medical device industry has strived to reduce costs through outsourcing. An industry report has found that the global medical device outsourcing market was valued at $33.2...more

FDA Enforcement Activities Update for FY 2016: CDRH Warning Letters Fall to 8-Year Low

The Food and Drug Administration (FDA) recently released statitistics regarding its enforcement actvities for FY 2016. Of note, the number of warning letters issued by the Center for Devices and Radiological Health (CDRH),...more

Capitol Hill Healthcare Update

Meeting privately with Senate Republicans to discuss next steps on the ACA was among the first actions taken last week by the new Secretary of the U.S. Department of Health and Human Services Tom Price. But GOP senators left...more

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

AGG Food and Drug Newsletter - February 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

FDA Devices Center Issues Multiple Guidances in the Obama Administration’s Final Months

A flurry of regulatory activity preceded the transition in administration on January 20. Anticipating that the new administration would impose a regulatory slowdown, the Food and Drug Administration’s (FDA’s or the...more

FDA 2016 Year in Review

The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more

After the Fact: FDA’s Guidance on Postmarket Management of Cybersecurity in Medical Devices

The Food and Drug Administration (FDA) recently issued nonbinding guidance focusing on the software vulnerabilities of networked medical devices that are already on the market. The guidance focuses on the importance of...more

Capitol Hill Healthcare Update

House Speaker Paul Ryan last week set a deadline of the end of March for repealing most of the Affordable Care Act (ACA), as other Republican leaders and conservative rank-and-file lawmakers advocated competing policy...more

Talk This Way: FDA Provides Guidelines on Medical Product Communications Consistent With the FDA-Required Labeling

Channeling Aerosmith’s 1975 single, “Walk This Way,” and the song lyric “Talk This Way,” the Food and Drug Administration issued a draft guidance to industry on how it can communicate certain types of product information...more

"FDA Publications Double Down on Agency’s Ability to Prohibit Off-Label Communications, but Narrow Scope of Debate"

On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more

One in, Two Out: Potential FDA Uncertainty for Medical Device and Pharmaceutical Companies

On January 30, 2017, President Trump signed an executive order requiring all governmental agencies to eliminate two regulations for every one issued. The Order, captioned “Reducing Regulation and Controlling Regulatory Costs”...more

FDA Issues Three Key Documents Relating to Medical Product Manufacturer Communications

On January 18, 2017, the Food and Drug Administration (“FDA”) released three key documents outlining the agency’s current thinking regarding drug and device manufacturers’ communication of information not contained in...more

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

FDA Offers Some Clarity (But Few Concessions) on Off-Label Communication of Medical Products

Among the flurry of policies the Food and Drug Administration (FDA) released in the waning days of the Obama administration are several documents that seek to clarify the agency’s positions on communications about medical...more

Privacy & Cybersecurity Newsletter

New York’s Cybersecurity Requirements for DFS Licensees: A New Item at the Top of the To Do List - With a compliance date a few months away, licensees of the New York Department of Financial Services (DFS) must start...more

FDA Off-Label Promotion Memo Should Affect §510k Preemption & Evidence

Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k “substantially equivalence” medical device clearance as non-preemptive because it was supposedly “focused on equivalence, not safety”? Id. at...more

FDA Outlines Substantially Revised ‘Possible Approach’ to the Regulation of Laboratory-Developed Tests

On January 13, 2017, the US Food and Drug Administration (FDA) posted a “discussion paper” in which the agency outlines a substantially revised “possible approach” to the oversight of laboratory-developed tests (LDTs). The...more

A "cure" for combination products: 21st Century Cures Act mandates greater transparency of combination product designations

The 21st Century Cures Act ushers in significant changes to the regulatory review of drug/biologic/device combination products. The regulation of combination products has been somewhat unpredictable and muddled over the last...more

AGG Food and Drug Newsletter - January 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Expansion of the Humanitarian Use Device Program under the 21st Century Cures Act

The 21st Century Cures Act, signed into law in December 2016, ushered in a number of changes that will affect the Food and Drug Administration’s product development programs. One such example relates to the expansion of the...more

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