The U.S. FDA has posted a draft guidance that will overwrite a 2014 draft guidance dealing with MRI compatibility for medical devices, but at least one observer is concerned that the agency posted draft as standards-setting organizations are rewriting their own related device performance standards, a fact that could draw out the time to completion of the draft.

Dublin-based Medtronic plc has filed a PMA supplement with the U.S. FDA for its next-generation, implantable sacral neuromodulation (SNM) device, Interstim Micro, and for its Interstim Surescan MRI leads. Interstim Micro is intended to help patients with overactive bladder (OAB), urinary urge incontinence, unobstructed urinary retention and fecal incontinence (FI).

The device industry is quite familiar with whistleblower lawsuits, but Cisco Systems Inc., of San Jose, Calif., was recently forced to pay more than $8 million in connection with a qui tam lawsuit over cybersecurity lapses for video surveillance equipment sold to state and federal government agencies. The case suggests device makers will have to be up to speed on cybersecurity if they wish to avoid suffering a similar fate, particularly given a recent warning the FDA posted regarding a widespread cybersecurity vulnerability.

Sterigenics US LLC, of Oak Brook, Ill., has announced it will not reopen its ethylene oxide (EtO) sterilization plant in Willowbrook, Ill., a development that could strain the capacity for sterilization of devices such as duodenoscopes. Illinois is not the only state that is taking action on EtO, however, a predicament that suggests the U.S. federal government may have to insert itself into the discussion in order to avoid a shortage of critical, life-saving devices.

The FDA has reissued a 2017 draft guidance for clinical decision support (CDS) applications as part of a reexamination of software regulations, and one difference between the 2017 draft and the latest iteration that is sure to cheer developers is that the agency now provides much more clarity as to the types of functions that will and will not fall under regulatory scrutiny going forward.

BOSTON – The 2019 Medtech Conference included the annual FDA town hall session, and Jeff Shuren, director of the agency's device center, said the pace of scientific change is outstripping the agency's ability to keep up. Shuren said the solution might be "regulatory Legos," an approach that might eliminate the need to go to Congress for new statutory authorities every time device makers carve open a new technological frontier.

The FDA's Center for Devices and Radiological Health has released yet another draft guidance dealing with medical device premarket programs with the release of a draft guidance for the accreditation scheme for conformity assessment. The draft frequently references independent standards for assessing device performance and safety, thus bringing regulatory harmonization one step closer to a practicable reality.

The U.S. FDA's emphasis on device safety is well known. Now, the agency has published a draft guidance that aims to provide expedited reviews for device and diagnostic applications that are "reasonably expected to significantly improve" safety, which, in conjunction with the breakthrough devices program, suggests that many other applications will be in the queue for increasingly longer periods of time.

HONG KONG – Dreamed Diabetes Ltd., of Petah Tikva, Israel, has received both FDA clearance and the CE mark for an insulin dosing decision support software based on artificial intelligence (AI).