Medical Devices

In final guidance released Monday (Feb. 4), FDA lays out how it will apply least burdensome provisions of medical device review to a device’s total product lifecycle, rather than just the premarket phase, while still ensuring devices meet safety and efficacy standards.

Experts in the antibiotic and medical device industries say FDA’s recent guidance for device and antibiotic makers on how to coordinate antibiotic susceptibility test (AST) development addresses a niche problem that should encourage more interest in antibiotic development.

An FDA official on Tuesday (Jan. 29) told a group of stakeholders that legacy medical devices remain an “intractable challenge” for promoting cybersecurity in the medical device space, a view also held by agency chief Scott Gottlieb who, on the same day, stated that one of FDA’s most critical challenges lies in addressing safety risks posed by the devices.

Top medical device lobbyists are pitching a legislative proposal that would let FDA accept user fees for new device applications during the partial federal government shutdown. Lobbyists say the proposal would prevent the agency’s device center from running out of funding during the shutdown and allow reviewers to work on a growing backlog of new device submissions.

FDA released final guidance on Thursday (Jan. 17) that the agency says will encourage the development of antimicrobial susceptibility tests (ASTs) to help determine whether a pathogen will likely respond to, or has developed resistance to, certain antimicrobial drugs.

Device industry experts disagree over whether a suite of new documents related to FDA’s nascent medical software precertification program answers a key question posed by stakeholders: Does the agency have statutory authority to implement pre-cert?

FDA issued a batch of announcements on Monday (Jan. 7) aimed at shoring up support for its software precertification test program, including a new pre-cert working model, a 2019 test plan and a regulatory framework.

Greg Garcia, executive director for cybersecurity of the Healthcare and Public Health Sector Coordinating Council, says the group will be gearing up over the next few weeks to encourage widespread adoption of recently issued cybersecurity guidelines, as it also develops a process for measuring the effectiveness of the voluntary guidance for reducing cyber risks for hospitals, patients and the rest of the medical community.

Nearly two weeks into a government shutdown that has left 41 percent of FDA employees furloughed, an agency expert says the shutdown will disrupt FDA’s long-term planning because it will put off settling the question of how much funding the agency will receive from Congress in 2019.