Devices

ACLA Views on PCCP Draft Guidance

Although the American Clinical Laboratory Association maintains that FDA lacks authority to regulate laboratory-developed tests (LDTs), it is submitting comments to an agency draft guidance on predetermined change control plans (PCCPs) for medical devices. “In the event that FDA’s final rule to regulate LDTs as medical devices is implemented and deemed lawful in a court of law, we submit these comments to ensure that PCCPs can be leveraged by laboratories to support continued rapid innovation of diagnostics to meet patient needs,” the comment letter says.

The association says that the modifications that would be appropriate for a PCCP under the draft guidance are too narrow to encourage meaningful iterative improvement of diagnostics without repeated cycles of premarket review. “The types of modifications that are appropriate for a PCCP must be expanded,” it says. “The guidance should also clarify that a PCCP may allow modifications to a cleared or approved in vitro diagnostic (IVD) test kit to be implemented by high-complexity clinical laboratories, rather than the manufacturer of the IVD test kit, without FDA premarket review. Finally, the statutory standard for evaluating a PCCP does not include an evaluation of the regulatory history of the subject device nor of the submitter and, accordingly, FDA should not take such histories into consideration.”

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