2016 Hospital Management Manufacturing 
FDA Law Blog
FEBRUARY 22, 2023
In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Consider this scenario: A manufacturer files a 510(k) for a Class II device, a surgical mask. 9, 2022).
FDA Law Blog
APRIL 11, 2022
Shapiro — One of the more complex areas of device regulation is the management of risks associated with malfunctions reported from the field. As background, Medtronic manufactures the MiniMed 600 series insulin infusion pumps. As background, Medtronic manufactures the MiniMed 600 series insulin infusion pumps. By Jeffrey K.
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FDA Law Blog
OCTOBER 10, 2022
The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. While the final guidance continues to borrow some IMDRF concepts, it no longer limits Non-Device CDS to software that informs clinical management (per the IMDRF guidelines).
FDA Law Blog
NOVEMBER 8, 2022
Fellow panelist, August Bencke Geyer, who serves as Deputy General Manager of the Medical Devices Office at ANVISA (Brazilian Health Regulatory Agency) expressed enthusiasm and indicated that Brazilian regulators are watching closely to see how the program unfolds. It’s an easy way to manage the transition.”.
FDA Law Blog
SEPTEMBER 13, 2021
A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.
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