The FDA responded on Thursday to longtime industry calls for the agency to clarify the distinction between the “serving” and “remanufacturing” of a medical device with new draft guidance to provide consistency and a better understanding of the applicable statutory and regulatory requirements. The 35-page document details its current thinking on the distinction.

With the advent of wearable digital health technologies, patient-generated health data (PGHD) will play an increasingly central role in evidence generation for medical device companies. Speakers on a recent FDA workshop advised that there are several barriers to the use of PGHD for evidence generation, however, such as the perennial headache of data interoperability and a new twist on the question of patient trust, problems that are likely to plague the field for the foreseeable future.

The U.S. government on June 17 announced plans for a multi-faceted $3.2 billion investment in the development and manufacture of new antivirals for preventing serious COVID-19 illness and death.

Livanova plc has launched an IDE trial of its Aura6000 sleep apnea device, following approval by the FDA to proceed with the study. The implantable pulse generator (IPG) is designed to treat patients with moderate to severe obstructive sleep apnea (OSA) who do not get relief from a traditional continuous positive airway pressure (CPAP) machine or refuse to use one.

With paralysis affecting more than 5 million Americans, devices that serve as brain-computer interfaces (BCIs) are increasingly important, even if few are commercially available. The FDA has responded to the predicament with a leapfrog guidance, a preliminary form of guidance designed to foster more interaction with industry and encourage developers to move along on development programs for devices that will aid patients in restoring lost motor and/or sensory capabilities.