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Manufacturers › Food and Drug Administration (FDA) › Manufacturer Liability

Environmental General Counsel PC

CalRecycle Releases New EPR Packaging Regulations: Imminent Compliance, New Exclusions, and Deferred Eco-Modulation Implementation

Environmental General Counsel PC on

A lot is going on in the extended producer responsibility (“EPR”) packaging world this month.  Maryland and Washington became the sixth and seventh states respectively to enact EPR packaging laws.  And this week, just a...more

Napoli Shkolnik

Product Liability: How it Works For and Against Victims of Defective Medical Devices

Napoli Shkolnik on

Crafting the perfect medical device is never an exact science—but a patient should never suffer because of defects in a product that was intended to improve their quality of life. Determining whether a device manufacturer or...more

Oberheiden P.C.

FDA Warning Letter Response Strategies (Step-By-Step)

Oberheiden P.C. on

FDA Warning letters can be harbinger of formal civil and criminal investigations. If your business receives such a notice of non-compliance from the FDA, you should immediately contact an experienced FDA defense attorney....more

ArentFox Schiff

Purple Means DNR: FDA Issues Letter to Medical Device Manufacturers on Color-Coded Wristbands

ArentFox Schiff on

Hospitals have long used color-coded wristbands as a patient safety initiative. Recently, the FDA issued a letter to medical device manufacturers to caution them against using colors for device identification wristbands that...more

Faegre Drinker Biddle & Reath LLP

Products in a New Dimension: Manufacturing Considerations for 3D-Printed Products

Faegre Drinker Biddle & Reath LLP on

Since its advent more than 30 years ago, the 3D printing market has grown, and will continue to expand for a myriad of reasons, including sustainability and reduced energy consumption. As the process, including the applicable...more

Mintz - Health Care Viewpoints

Update on FDA’s Comprehensive Regenerative Medicine Policies and Enforcement Activities

Mintz - Health Care Viewpoints on

Since our 2018 year-end post on the busy FDA regulatory agenda, we are nearing the halfway mark of the “grace period” the Agency has extended for certain regenerative medicine product developers to come into compliance by...more

Patrick Malone & Associates P.C. | DC Injury...

After thousands of lawsuits, FDA bans mesh used in pelvic prolapse procedures

Patrick Malone & Associates P.C. | DC Injury... on

After years of patient complaints about injuries and tens of thousands of lawsuits, the federal Food and Drug Administration yanked from the market a surgical mesh widely used to repair pelvic conditions in women....more

Akin Gump Strauss Hauer & Feld LLP

A Client’s Guide to FDA Recalls

Akin Gump Strauss Hauer & Feld LLP on

Recent FDA Recall Highlights & Developments - • The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the...more

King & Spalding

FDA’s Focus on Devices Impacting Women’s Health is Fully Underway: Breast Implant Advisory Set for March 25-26

King & Spalding on

Late last year, the Food and Drug Administration’s (FDA’s) Device Center announced a new objective when it comes to devices – “ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and...more

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