Additional guidance documents are expected.

The US Food and Drug Administration’s (FDA’s) first quarter of calendar-year 2016 has been a busy one on the medical device front. FDA’s Center for Devices and Radiological Health (CDRH) started the year by issuing several guidance documents, including five final guidances and 10 new draft guidances. In addition, CDRH has issued multiple device reclassification orders, continued to pursue unapproved in vitro diagnostic (IVD) tests, and proposed to use its authority to ban a device for only the second time ever.

Top trends emerging from this first quarter include the following:

IVD Enforcement for Unapproved DTC and Zika Tests

FDA’s Office of In Vitro Diagnostics and Radiological Health (OIVDRH) continued its trend in enforcement against unapproved tests marketed under a direct-to-consumer (DTC) model. After issuing four “It has come to our attention” letters for unapproved DTC tests in the last quarter of 2015, OIVDRH issued two more this quarter, including one to SoloPap for its home human papillomavirus and pap tests and one to Sure Genomics, Inc. for its SureDNA test (intended for DNA sequencing and reporting of patient information, such as disease risks and the likelihood of drug reactions). FDA also issued four letters to various companies marketing unapproved tests for the Zika virus.

Cybersecurity

FDA’s continued emphasis on medical device cybersecurity was evidenced in January, when it held the two-day public workshop, “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity,” which was cosponsored with the US Department of Homeland Security, the National Health Information Sharing and Analysis Center, and the US Department of Health and Human Services. Among other things, the agencies sought to discuss with stakeholders the unresolved gaps and challenges hampering progress for medical device cybersecurity. Also in January, FDA issued a new draft guidance document: Postmarket Management of Cybersecurity in Medical Devices. 

Rulemaking to Address Safety Issues for Currently Marketed Devices

FDA made headlines in March after it issued a proposed rule to ban powdered surgeons’ and patient examination gloves, marking only the second time ever that FDA has invoked its authority under the Federal Food, Drug, and Cosmetic Act to ban a device. FDA determined that the risks presented by these powdered gloves, including acute severe airway inflammation due to absorbable dusting powder inhalation, were unreasonable given that suitable alternatives are readily available in the current market. FDA also has issued multiple reclassification actions this quarter, including its reclassification of transvaginal surgical mesh devices from Class II to Class III in January. This device has long been the subject of safety concerns, such as severe pelvic pain, bleeding, and infection, and has resulted in multiple lawsuits against device manufacturers.

Human Factors

FDA’s continued concern about the impact of human factors and usability engineering on the safety and effectiveness of medical devices was underscored in February, when the agency issued three new guidance documents on these topics: Final Guidance: Applying Human Factors and Usability Engineering to Medical Devices, Draft Guidance: List of Highest Priority Devices for Human Factors Review, and Draft Guidance: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development. FDA also held a webinar on February 19 on the “Applying Human Factors and Usability Engineering to Medical Devices” final guidance.

Unique Device Identification (UDI)

As UDI implementation moves forward, FDA continues to provide more training and guidance to industry. In January, FDA issued the new draft guidance, Unique Device Identification: Convenience Kits.” FDA issued another draft guidance in February, Enforcement Policy on National Health Related Item Code [NHRIC] and National Drug Code [NDC] Numbers Assigned to Devices, which addresses legacy NHRIC and NDC numbers for medical devices, something many device companies used on their device labels prior to the 2012 legislation that required FDA to adopt a standardized UDI system. FDA also added in March new UDI modules to its CDRH Learn web page for industry training and education.

What’s Next?

So, what’s next on FDA’s agenda for medical devices? The agency has identified several areas for guidance development this fiscal year, including finalization of its high-profile draft guidances for “Medical Device Accessories” and “General Wellness: Policy for Low Risk Devices” (first issued in January 2015). On the UDI front, FDA has flagged its “UDI Direct Marking” draft guidance for finalization. Software issues are also high on FDA’s priority list, including the much-anticipated “Clinical Decision Support Software” draft guidance and a new draft guidance on “Software Modifications.” With regard to IVDs, FDA has prioritized its controversial draft “Policy for Regulatory Oversight of Laboratory Developed Tests” for finalization and a new draft guidance for “Companion Diagnostics Co-Development.” Further guidance on genetic testing may also be in the works, as FDA has signaled these issues are top of mind, holding two public workshops in February and March—the first on next-generation sequencing-based oncology panels and the other on patient and provider perspectives on receiving genetic test results.