Author: andrewmiller

Alliance One-Pager on Medical Device Cybersecurity

Cybersecurity poses a significant threat to our nation’s critical infrastructure, and no sector is impacted more than healthcare. Cyberattacks led by nation-states and other cybercriminals are a regular and growing occurrence. Current headlines depict the detrimental impacts of cyberattacks on patient safety and care and healthcare organizations’ finances. Healthcare is the: · most attacked, · […]

Alliance Comments to FDA on Cybersecurity of Medical Devices

Division of Dockets Management (HFA‐305)Center for Devices and Radiological HealthFood and Drug Administration5630 Fishers LaneRockville, MD 20852 September 22, 2021 Ref: Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices: Challenges and Opportunities Docket No. FDA-2021-N-0561 Dear Sir/Madam: This is to submit comments to the discussion paper reference above. I. Introduction of Alliance Before providing […]

Comments on FDA Draft Guidance for Remanufacturing of Medical Devices

Dockets Management Staff Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 September 20, 2021 Docket No. FDA-2018-N-3741:  Remanufacturing of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff, issued on June 24, 2021 (the “Draft Guidance”)   Dear Sir/Madam: This document is to submit comments to the Draft Guidance […]

Accountability in Medical Device Servicing

The care and servicing of medical devices is a subject that rightly commands much attention, particularly as the accessibility and availability of critical medical devices became a focused topic during the COVID-19 pandemic.  Some of this attention increased calls for right to repair legislation pending in some states as well as similar legislation introduced in […]