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James Czaban and Sonali Gunawardhana Discuss the Top Issues for the Medical Devices Industry in 2016
James Czaban, chair of Wiley Rein LLP’s Food & Drug Law Practice and a partner in the firm’s Health Care Practice, and Sonali Gunawardhana, of counsel in the Food & Drug Law Practice, were quoted in a Bloomberg BNA article, discussing the top issues that will affect the medical devices industry in 2016. According to the article, regulating laboratory-developed tests (LDTs), concerns over cybersecurity, a new FDA user fees law, and possible guidance for clinical decision support software, are among the top issues.
Ms. Gunawardhana said that although the FDA historically exercised “enforcement discretion” over LDTs, “today, many of these tests may compete with FDA-approved tests without clinical studies to support their use.” “FDA has made it clear, as has CMS, that they have the ability and the experience to establish an LDT oversight framework, including pre-market review for higher-risk LDTs, such as those that have the same intended use as FDA-approved or cleared companion diagnostics currently on the market,” Ms. Gunawardhana said.
According to Mr. Czaban, how the regulatory framework on LDTs develops is likely to have long-lasting effects that reach beyond the tests themselves to the world of precision medicine. Given that diagnostic tests may be used to determine whether a patient will benefit from a particular therapy, the regulation of LDTs “will impact precision medicine as it goes forward, ” Mr. Czaban said.
The FDA is working proactively in the cybersecurity space, Gunawardhana said, noting that the agency, in collaboration with the National Health Information Sharing Analysis Center (NH-ISAC), the Department of Health and Human Services, and the Department of Homeland Security, is kicking off 2016 with a two-day public meeting to discuss complex challenges in medical device cybersecurity.
Ms. Gunawardhana also said that the FDA is planning to issue a guidance document to address post-market medical device cybersecurity issues, having previously issued one on pre-market issues.
The article points out that the FDA has published guidance on health-care-related mobile apps and data systems; it has explicitly said that the mobile apps guidance didn’t apply to Clinical Decision Software (CDS). Ms. Gunawardhana says the FDA’s promised draft guidance on CDS “will hopefully assist medical device manufacturers to better navigate the regulatory environment and keep patients safe with promising technology and advanced medical devices.”
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