…are also in high demand in Asia. Existing techniques use radiofrequency waves or freezing techniques. But a relatively new technique, High Intensity Focused Ultrasound (HIFU), is drawing particular interest. It…
…are also in high demand in Asia. Existing techniques use radiofrequency waves or freezing techniques. But a relatively new technique, High Intensity Focused Ultrasound (HIFU), is drawing particular interest. It…
…display emergency exit signage and mount fire extinguishers. Restaurant employees are required to wash hands often and comply with food safety specifications. The healthcare industry is no different—in fact, its…
…display emergency exit signage and mount fire extinguishers. Restaurant employees are required to wash hands often and comply with food safety specifications. The healthcare industry is no different—in fact, its…
…of Proposed Rulemaking for human subjects research protections (i.e., the Common Rule), was withdrawn because it would severely limit the conduct of diagnostics research. Other Proposed Regulatory Changes2 CDRH should…
…of Proposed Rulemaking for human subjects research protections (i.e., the Common Rule), was withdrawn because it would severely limit the conduct of diagnostics research. Other Proposed Regulatory Changes2 CDRH should…
…aims to identify principles, premarket review practices and policies for the agency’s regulatory assessment of these types of products and to also provide some application examples. Industry can submit comments…
…aims to identify principles, premarket review practices and policies for the agency’s regulatory assessment of these types of products and to also provide some application examples. Industry can submit comments…
…impact of potential new contracts with customers. Changes in: Revenue Recognition The new FASB revenue standard effective for public companies this year requires medical device companies to comprehensively reassess their…
…impact of potential new contracts with customers. Changes in: Revenue Recognition The new FASB revenue standard effective for public companies this year requires medical device companies to comprehensively reassess their…
…for two years. During that two-year period, the IVD is entirely self-pay. After those two years, it normally takes six months to obtain a new IVD reimbursement rate. Reimbursement may…
…for two years. During that two-year period, the IVD is entirely self-pay. After those two years, it normally takes six months to obtain a new IVD reimbursement rate. Reimbursement may…
…as a timed-release medium seeded by, or implanted into, living cells and tissue. Research has exploded over the past decade, moving quickly towards real-life applications—from edible lab burgers to new…
…as a timed-release medium seeded by, or implanted into, living cells and tissue. Research has exploded over the past decade, moving quickly towards real-life applications—from edible lab burgers to new…
…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Laser Dental Innovations. Access April 21 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm599613.htm…
…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Laser Dental Innovations. Access April 21 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm599613.htm…
…or the completeness of the information in the packet. In some cases, firms may wish to secure the services of a third-party reviewer to provide comment on the submission prior…
…or the completeness of the information in the packet. In some cases, firms may wish to secure the services of a third-party reviewer to provide comment on the submission prior…
…them. Providing this security is a continual effort that requires vigilance, adaptation, and ongoing communication and collaboration between the parties.” – HSCA Register for the Medical Cybersecurity & Patch Management…
…them. Providing this security is a continual effort that requires vigilance, adaptation, and ongoing communication and collaboration between the parties.” – HSCA Register for the Medical Cybersecurity & Patch Management…
