Devices

Cures Act Answers Some Software Questions: Attorney

The 21^st Century Cures Act provides some clarity on categories of software that are excluded from the statutory medical device definition and thus FDA jurisdiction, according to attorney Suzan Onel (Kleinfeld Kaplan & Becker.) Writing in an online Alert, Onel says that even with the clarification, some questions remain, particularly involving provisions of the law that appear to give the agency authority to bring back under its jurisdiction some excluded software categories.

Onel says the Cures Act outlines five categories of software that are excluded from the device definition and exempt from agency regulation, including software intended:

for administrative support of a healthcare facility;
for maintaining or encouraging a healthy lifestyle and unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;
to serve as electronic patient records to the extent that such records are intended to transfer, store, convert formats, or display the equivalent of a paper medical chart;
for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results, findings by a healthcare professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device, unless the function is to interpret or analyze clinical laboratory test or other device data results and findings; and
for the purpose of displaying, analyzing, or printing medical information about a patient or other medical information, supporting or providing recommendations to a healthcare professional about prevention, diagnosis, or treatment of a disease or condition, and enabling such a healthcare professional to independently review the basis for such recommendation that the software present.

Onel notes that it will be some years before FDA promulgates regulations implementing the act and, under the current administration, it may be some time before it issues a draft guidance to provide its thinking on how it will implement the provisions. “Industry will need to remain vigilant as to how FDA interprets these exclusions, particularly vague terms …,” she concludes.

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

Read more

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