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.

Bellus Medical, LLC. Dallas, TX (9/13). FDA inspected the firm in March and determined that it markets the SkinPen II device without having submitted a 510(k). FDA said that general devices classified under 21 CFR 878.4820 (Dermabrasion Brush, Powered) are exempt from premarket notification. However, it said the SkinPen II is a microneedling device intended to achieve its clinical effect through the creation of many small puncture wounds in the skin using an array of needles, and thus raises different questions of safety and effectiveness. It was also concerned because the safe ranges of needle lengths, penetration depths, and speeds of the device are unknown. Additionally, concerns were raised on infection and cross-contamination due to the reusable portion of the device.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm520649.htm

Collagen Matrix, Inc. Oakland, NJ (9/20). An 11/2015 FDA inspection at the firm’s Oakland and Franklin Lakes, NJ facilities found GMP and quality system violations. For example, the firm failed to adequately conduct design validation on its ZCORE Porcine Xenograft Particulate in Syringe device. Additionally, FDA cited the firm for making significant design changes to ZCORE since its initial 510(k) clearance in 2014, and such changes could significantly affect the safety and effectiveness of this device. For example, changes to packaging and delivery via the manufacturing process of the device presents biocompatibility and sterilization validation concerns. For such a change, FDA says a 510(k) submission is required to demonstrate that the polymers used in the syringe applicator/packaging do not give off leachables or extractables that could contaminate the biocompatibility of the materials in the device.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm522402.htm

Navinta, LLC. Ewing, NJ (9/26). FDA inspected the firm in May and documented serious violations of the Postmarketing Adverse Drug Experience (PADE) reporting requirements. Specifically, the firm failed to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences (ADEs). Although there is a written agreement for a product distributor, there is no procedure between the two parties describing how notification of ADEs will be performed. Further, the agreement does not describe how non-serious ADEs will be addressed.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm522920.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