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Medical device companies that participate in the program can engage and collaborate with solutions providers and the FDA to demonstrate advanced technologies. Read More
An FDA final guidance on premarket submissions for device software functions recommends a risk-based approach to help determine whether the sponsor should submit basic or enhanced documentation to explain its use of new data processing methods. Read More
The recall of Walnut Wearable smart thermometer, a device that continuously monitors body temperature of infants and children up to 6 years, is now deemed FDA Class I, the most serious type of recall as use of the device may cause serious injuries or death. Read More
The FDA will not let Intarcia choose reviewers for the upcoming Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to consider the company’s troubled diabetes drug-device product, nor will the agency grant other requests Intarcia made last month. Read More
Organizations should identify the potential impact of a hurricane on the supply chain, operations and facilities as well as consider stockpiling materials in the event of a disruption. Read More
As part of the FDA’s effort to increase access to home-use medical devices, CDRH is seeking comments from devicemakers, researchers, clinicians and the public on how to bring healthcare directly to patients wherever they are — at home, at work, in cities or in rural communities. Read More
The FDA published multiple guidances on Friday to help sponsors conduct drug-drug interaction studies for therapeutic proteins, develop drugs for treating bladder pain syndrome, nonclinical evaluation of drug immunotoxic potential and request feedback from agency officials on device submissions under the Q-Submission program. Read More
Medical device manufacturers should prepare now for the potential disruption in fluctuating power, contaminants or unusual levels of heat or humidity that often occur during hurricane season, the FDA advises. Read More
CDER’s Office of Surveillance and Epidemiology (OSE) 2022 Annual Report showed the total number of adverse event (AE) reports rose slightly from 2.23 million in 2021 to 2.34 million, capturing patient adverse reactions along with medication error reports and product quality complaints. Read More
The FDA and the Medical Device Innovation Consortium (MDIC) are collaborating to offer funding of up to $300,000 to medical devicemakers that use advanced technologies to enhance product quality or improve the manufacturing process. Read More