Manufacturers The United States Food and Drug Administration

News & Analysis as of

Court Strikes FDA Preapproval for Tobacco Product Labeling Changes

Court holds that FDA guidance cannot require preapproval for label modifications to existing tobacco products, but can require preapproval for quantity modifications....more

New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s...more

When Is a Software Change Really a Change that Requires FDA Review?: When to Submit a 510(k) for a Software Change to an Existing...

On the same day the Food and Drug Administration issued its revised draft guidance document on when to submit a new 510(k) premarket notification for an existing medical device, it released a similar document specific to...more

FDA Releases Revised Guidance on Device Modification Policy

FDA released two new draft guidances on Monday, August 8 in an attempt to help device manufacturers determine when a modification triggers the obligation to file a new 510(k) under 21 C.F.R. § 807.81(a)(3). The first draft...more

DEA Expands Marijuana Manufacturing But Refuses to Reclassify Schedule I Drug

On Thursday, the DEA announced a policy change expanding the number of DEA-registered marijuana manufacturers producing marijuana for research. This move is expected to expand and diversify the supply of marijuana for...more

New FDA Draft Guidance on Benefit-Risk Factors Affecting Medical Device Compliance and Enforcement

In June, the U.S. Food and Drug Administration released draft guidance to clarify the benefit and risk factors it may consider in compliance and enforcement actions involving medical devices. Medical device manufacturers...more

King & Spalding Lawyers Discuss The Regulatory Landscape At Medical Device Cybersecurity Risk Mitigation Conference

On July 25 and 26, 2016, industry stakeholders assembled in Arlington, Virginia, to participate in the Medical Device Cybersecurity Risk Mitigation Conference sponsored by Q1 Productions. The conference focused on the...more

Mobile Apps - Has the Marketplace Downloaded Potential Product Liability Risk?

For many consumers, it is hard to remember performing a daily routine without using a mobile application. App usage starts almost immediately - with a morning alarm that wakes you up slowly or with a coffee waiting for you at...more

FDA Issues Final Guidance on General Wellness Products

On July 28, 2016, the United States Food and Drug Administration (FDA) finalized guidance stating that the agency does not plan to regulate “general wellness products,” including software applications, provided they present a...more

The Promise And Pitfalls Of 3D Printing

3D printing offers great promise for innovation and manufacturing, but this tool has expanded the scope of patented products that can be easily and cheaply copied, and may make it harder to identify and prosecute infringers....more

E-Cigarette Makers Contending with New CPSC and FDA Regulations

Products like e-cigarettes and other electronic nicotine delivery systems (ENDS) have been under intense scrutiny in recent years from public health officials, legislators at all levels of government, and many other...more

The Future of Medical Device Manufacturing Is Here: FDA Issues Draft Guidance on Technical Considerations for 3D Printing

A few years ago, a custom-fabricated bioresorbable tracheal splint saved the life of an infant suffering from a collapsed bronchus due to severe tracheobronchomalacia. The splint was implanted around the baby’s airway,...more

AGG Food and Drug Newsletter - July 2016

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

BioPharma Patents Quick Tips & News – July 2016

U.S. FDA Orange Book Refresher Edition - What types of patents can be listed on the FDA’s Orange Book? Listable = Pharmaceutical-related patents are allowed in the FDA’s Orange Book only if they’re “composition” or...more

Lowered Risk for Inventors Who Use Contract Product Development or Manufacturing

On July 11, in The Medicines Company v. Hospira, Inc., the Federal Circuit held that a contract manufacturer's sale of manufacturing services to an inventor did not constitute a commercial sale of the patented invention for...more

FDA Offers Draft Guidance for Generic Drug Label Updates

In July 2016, the U.S. Food and Drug Administration (FDA) published draft guidance outlining when drug companies should update a generic drug’s label after the brand name drug on which the generic is based has been withdrawn...more

New FDA Draft Guidance on Updates to Certain Generic Labeling

On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for...more

Medical Device Updates: U.S. Food and Drug Administration (FDA) Practice Trends

Data and Analytics — FDA’s Post-market Surveillance Data Proposals Press Forward - FDA’s National Evaluation System for Health Technology, or NEST, as FDA calls it, is quickly gaining traction as one of the...more

Summary of FDA Draft Guidance: Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and...

On June 16, 2016, the Food and Drug Administration (FDA) released a draft guidance entitled Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions[2]. The...more

FDA Regulatory and Compliance Monthly Recap – June 2016

FDA issues draft guidance to update policy on categorizing investigational device exemption devices to assist CMS coverage decisions - The draft guidance will amend the FDA’s 20-year-old policy for categorizing devices...more

FDA Issues Final Rule on Use of Symbols in Labeling

The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory...more

FDA Issues Draft Guidance on Dissemination of Patient-Specific Information from Devices

On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued a draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices....more

Another Prescription Drug Warnings Preemption Decision

Not that our readers are dying for a glimpse behind the curtain into the making of the sausage (and mixed metaphors) of the blog, but we do try to first figure out what decisions may be blogworthy before we start writing up...more

3D Printing Quarterly Report - Q2 2016

3D printer shipments in U.S. jump 20% in 2015: IDC - International Data Corp (IDC) research found 3D printer shipments in the U.S. grew by almost 20% in 2015 compared to 2014. Looking ahead, 3D printer shipments in the...more

Picture of Health: FDA Rule Allows Symbols to Replace Text on Device Labels

In June 2016, the U.S. Food and Drug Administration (FDA) issued its final rule explicitly allowing the use of approved symbols, without accompanying text, on medical device and certain biological product labeling. The FDA...more

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