The U.S. FDA has engaged in an overhaul of its software policies in the wake of the mandates spelled out by the 21st Century Cures Act. However, those policies are still a work in progress, as a recent FDA webinar made clear. The FDA won’t have long to put those policies into place as the U.S. House of Representatives is considering a follow-on to the Cures Act, dubbed Cures 2.0, which will impose yet more changes on the agency’s approach to software regulation.
Menlo Park, Calif.-based startup Tusker Medical Inc. has received U.S. FDA approval to market its breakthrough-designated system for inserting tympanostomy tubes into the eardrum to treat recurrent ear infections. The Tubes Under Local Anesthesia (Tula) system is the first delivery system for tympanostomy tubes, commonly known as ear tubes, that can be performed in young children under local anesthesia in a doctor’s office. The Tula system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes and several devices for inserting the anesthetic and tubes into the ear drum. A low-level electrical charge delivers the anesthesia to the eardrum prior to tube placement, allowing for quick and needle-free numbing of the tympanic membrane.
The FDA has posted the names of the companies that will take part in the ethylene oxide (EtO) challenge in response to the recent state action against EtO device sterilization sites, but the agency also has opened a pilot program for a streamlined notification process for changes to sterilization that should be faster and leaner than the usual PMA supplement.
Shares of Eyegate Pharmaceuticals Inc. (NASDAQ:EYEG) rose 54.8% to $7.09 Friday on news that its ocular bandage gel (OBG) proved superior to standard of care in healing corneal wounds following photorefractive keratectomy (PRK) surgery. The pivotal top-line data will allow the Waltham, Mass.-based company to submit a de novo application to the FDA for commercialization in the first half of 2020, said CEO Stephen From. If approved, the OBG eye drop would be the first product indicated to repair corneal epithelial defects, as well as the first prescription hyaluronic acid (HA) eye drop in the U.S., creating new competition for widely used bandage contact lenses (BCL).
Patient engagement has become more than a buzzword for the FDA and drug and device developers. But for payers, not so much. When valuing new drugs and devices, payers often undervalue or ignore what they may consider convenience updates, giving little to no consideration to the difference a seemingly minor improvement could make to patients debilitated by fatigue, pain, the burden of treatment and the burden of a disease itself.
The U.S. FDA has given Medtronic plc a green light for its In.Pact AV drug-coated balloon, the second application for the Dublin-based company’s In.Pact DCB platform. The paclitaxel-coated balloon is now indicated for the treatment failing arteriovenous (AV) access in patients undergoing dialysis due to end-stage renal disease (ESRD). In.Pact AV leverages technology from Medtronic’s In.Pact Admiral DCB, which first snagged FDA approval in 2015 for treatment of superficial femoral artery (SFA) lesions above the knee.
The FDA’s safety and performance-based pathway for 510(k) devices promises to streamline premarket filings, and the FDA’s Jason Ryans said on a recent webinar that any changes to the related product-specific guidances would be applicable only prospectively. Ryan made no mention of a grace period for impending applications, however, suggesting that any such devices may have to be reworked or resubmitted into a more conventional premarket channel if they do not meet the new requirements.
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