Devices

Home-Use Device Labeling Rule ‘Redundant’: Stakeholders

AdvaMed and Abbott Laboratories say an FDA proposed rule on electronic submission of labeling for certain home-use medical devices is redundant and should not be pursued. The AdvaMed comment letter says the rule is not needed because device labeling information is widely available to users, and many manufacturers of home-use devices provide labeling information for products through their Web sites.

Also, AdvaMed says, a labeling database proposed in the rule may confuse device users, such a proposed database should not be linked to other FDA systems, there should be exceptions and sunset periods, and additional clarity is needed when multiple parties are involved.

Abbott comments that it would be preferable for FDA to remove barriers to manufacturers of home-use devices in providing electronic versions as the sole means to convey device labeling, as is permitted for prescription medical devices used in healthcare settings.

Procter & Gamble says that the proposed requirement for electronic submission of the device label and package insert for all Class 2 medical devices labeled for use outside a professional healthcare facility “could create a regulatory burden greater than the proposed public health benefit for some categories of Class 2 devices.” The company recommends an exemption for products that have a low potential for misuse, either due to the nature of the device or due to the frequency of purchase of products that provide for a resupply of labeling. “Usage of these products is known to the population who purchases the product and usage information, warnings, and contact information for the manufacturer are included in each product package which is purchased at regular intervals,” it says. “In addition, information is available on the product Web site, therefore, additional submissions to FDA would be redundant. Further, as these are single-use products, no maintenance instruction is required.”

Finally, Mylan says that overall it welcomes the proposed rule and requests clarification regarding the intent of the agency’s “review” of the label and package insert of home-use devices.

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