Devices
FDA has denied an 8/25/16 petition asking that the agency either (1) promulgate a final regulation banning electroconvulsive therapy (ECT) devices or (2) maintain the Class 3 classification of these devices and issue a final order establishing the effective date for PMAs for all ECT devices. A 2018
Devices
FDA says it plans to implement the Software Precertification Pilot Program under the de novo pathway as described in a regulatory framework paper. The paper says the goal of this phase of the pilot is to “determine the contours of a possible regulatory model that provides efficient regulatory oversight of
Devices
FDA has classified as Class 1 a Medtronic recall of its Synergy Cranial Software and Stealth Station S7 Cranial Software due to reports of incorrect information displaying during biopsy procedures that could result in serious or life-threatening patient harm. The software is used with the company’s StealthStation Surgical
Devices
Attorney Paulette Thomas (BaketHostetler) says it is imperative that hospitals and other vendors take seriously the FDA Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, which she describes as the latest step in the agency’s ongoing effort to enhance medical device security. Writing in an online HIT Consultant
Devices
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says an FDA push for “predicate modernization” to promote medical device innovation is not likely to cause any problems, but also is not necessary. Writing in his firm’s FDA Law Blog, Shapiro says FDA has said that when companies submit a 510(
Devices
FDA has cleared an Empatica 510(k) for its Embrace, a pediatric epilepsy smartband that detects patterns in motion and physiological signals that may be associated with generalized tonic-clonic seizures, and immediately alerts caregivers. The company says it is the first non-EEG based physiology signal seizure monitoring system
Devices
FDA has approved a MicroVention (a Terumo subsidiary) PMA for the WEB Aneurysm Embolization System for treating intracranial wide neck bifurcation aneurysms. The company says the device is the only PMA-approved device in the new category of intrasaccular flow disruptors for aneurysm embolization. PMA approval is based on data
Devices
FDA has cleared a Neocis 510(k) for additional dental materials to be used with Yomi, the company’s robot-assisted dental surgery system. Yomi provides computerized navigation to assist in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. “The system offers physical
Devices
FDA has issued a new Software Precertification (Pre-Cert) Pilot Program working model 1.0, Test plan, and regulatory framework to explain how it envisions regulating digital health devices by looking at information across the total product lifecycle. The pilot is now entering the test phase that will allow FDA
Devices
Endologix says it is discontinuing unrestricted sales of its Nellix stent graft for treating abdominal aortic aneurysms and limiting its use to pre-screened patients under a clinical protocol. The company is recalling all existing inventory data, and use under the protocol will first be pre-screened by a panel
Devices
Akonni Biosystems has filed a 510(k) to market the TruDiagnosis system, its proprietary microarray-based technology. The company says the in vitro diagnostic device is intended for genotyping multiple genes in a DNA sample using on-slide polymerase chain reaction gel-drop microarray technology to help detect clinically relevant
Devices
FDA has cleared a Tivic Health Systems 510(k) for the ClearUP Sinus Pain Relief, a bioelectronic treatment for sinus pain due to allergic rhinitis (hay fever). The over-the-counter handheld device uses microcurrent waveforms to provide sinus pain relief. Tivic Health says it is intended to glide along
Devices
FDA has granted Bruin Biometrics de novo clearance to market the SEM Scanner, a wireless handheld device that is indicated for use as an adjunct to the standard of care when assessing patients who are at increased risk for pressure ulcers. The device is designed to objectively alert clinicians to
Devices
FDA commissioner Scott Gottlieb and CDRH director Jeffrey Shuren say the agency has taken two additional steps to spur innovation of medical products so that patients can have access to safe, effective treatments that improve or save lives. They say the Safer Technologies Program (STeP) aims to encourage innovation and
Devices
An independent Booz Allen report assessing FDA’s medical device review process as required by MDUFA 3 and MDUFA 4 says that CDRH staff are aware of and use the products and resources developed and implemented by the Center for all recommendations the consultants made as part of their initial
Drugs
FDA commissioner Scott Gottlieb says the agency is taking steps to strengthen a mandated post-marketing study for Bayer’s Essure permanent birth control device that was withdrawn from the market 12/31/18. In a statement, Gottlieb says the agency worked with Bayer to see that it implements several
Devices
FDA has posted a draft guidance entitled “Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment.” The document provides clarification on the regulations that pertain to diagnostic x-ray systems and their major components. It contains two sections — one on general information relating to diagnostic x-ray
Devices
FDA has released a guidance entitled “Manufacturing Site Change Supplements: Content and Submission.” The document explains FDA’s current thinking on what constitutes a manufacturing site change and when you should submit a PMA supplement for a site change. It also addresses the documentation that should be submitted in a
Devices
FDA has cleared an EhmetDx 510(k) for its 3D CBCT (cone beam computed tomography) positioning software to be used in patient treatment at the McLaren Proton Therapy Center. The system is used to precisely guide the position of the proton beam in patient treatments, the company says.
Drugs
FDA’s authority to obtain equitable remedies in injunction suits may be in jeopardy in light of federal court questions in a Federal Trade Commission (FTC) case against Shire. Attorneys Jennifer Thomas and John Fleder (Hyman, Phelps & McNamara) write in their firm’s FDA Law Blog that the Shire
Devices
An FDA analysis required by the 21st Century Cures Act says that there generally are more benefits than risk to patient safety and health from the use of non-medical device software digital health products. The Cures Act excludes certain software functions from the statutory definition of a medical device
Devices
FDA says it is issuing a final rule to amend its regulations governing classification and reclassification of medical devices to conform to changes made in the FDA Safety and Innovation Act (FDASIA). A Federal Register notice says the rule also makes additional changes, unrelated to FDASIA, to update other affected