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The medical spa industry is rapidly growing, driven by technological advances and shifting consumer preferences for cosmetic and wellness services. While this growth offers many business opportunities for healthcare...more
Medical device, drug, food, cosmetic, and other FDA-regulated product manufacturers face the constant threat of product liability lawsuits. Claims of injuries from allegedly defective products can lead to significant...more
The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more
Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more
The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more
On October 1, 2018, the Food and Drug Administration (FDA) issued its “Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook” to address continued threats to medical devices that could affect...more
On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's regulatory approach to medical...more
With the continued explosion of software and software-controlled medical devices, including the growing use of machine learning and artificial intelligence, the FDA (the Agency) Medical Device Safety Action Plan (the Plan)...more
Connected medical devices deliver numerous benefits not available before, including improved monitoring of patient welfare and a wealth of vital data. But for all the advantages available through these devices, their...more
From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...more
On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more