FDA Policy/General

Latest FDA Warning Letters

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Mark Berman, Beverly Hills, CA (2/13): FDA inspected the physician’s operations 7/2018 and concluded he has been manufacturing a medical device known as the Pocket Protector, an expanded-polytetrafluoroethylene pouch used to line the inside of a breast pocket during breast augmentation procedures. The letter cites many of the marketing claims made for the device and says the agency “is not aware of an implantable device intended for use with breast implants, such as yours, that is legally marketed for this use. Therefore, FDA has determined that your device requires premarket approval as a Class 3 device.” Because Berman does not have an approved PMA or IDE in effect, the device is adulterated, the agency says. The letter acknowledges Berman’s claim that his device qualifies for a custom device exemption, and explains why FDA disagrees with that conclusion.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm631059.htm

Datascope Corp. Mahwah, NJ (2/6): FDA inspected the firm 7/2018 and cited GMP violations associated with its intra-aortic balloon pumps and Cardiosave IAB pumps (hybrid and rescue devices). For example, the company failed to perform design validation to include testing of production units under actual or simulated use conditions to ensure that devices conform to defined user needs and intended uses. It also failed to establish and maintain procedures for implementing corrective and preventive action. Additionally, Datascope was cited for failing to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm631272.htm

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome