<h1 class="entry-title">Category: Uncategorized</h1>

FDA MDUFMA Small Business Determination (SBD) at the Pre-Revenue Stage

July 27, 2021 FDA MDUFMA Small Business Determination (SBD) at the Pre-Revenue Stage   Before addressing FDA’s MDUFMA fees and SBD program for a firm’s premarket submission when at a pre-revenue / premarket stage, my suggestion is to first remember that if a product clearance or approval [510(k) clearance, PMA approval, etc.] hasn’t happened yet, […]

Showing Conformity to Standards

July 16, 2021 Showing Conformity to Standards   Regardless of the source of a request for evidence showing conformity with applicable standards, a pivotal underlying fundamental remains the same and drives the answer:  Conformance with standards is generally a design/development verification and/or validation activity.  Therefore, the general rule of thumb is that there needs to […]

EU MDR Scope and Applicability of GSPR 10.4.1

July 12, 2021 EU MDR Scope and Applicability of GSPR 10.4.1   I think there is a good possibility that GSPR clause 10.4.1’s reference both to “invasive” and to “come into direct contact with the human body” may just be an ambiguous redundancy in describing invasive devices, as I have a hard time imagining an […]

FDA & ISO DMR/MDF vs. “Design Output”

April 1, 2019 FDA & ISO DMR/MDF vs. “Design Output” Remember that the DMR is intrinsically linked to the design control process.  The DMR is by formal definition a design output (see my preceding blog post).  It unequivocally lives and breathes in direct relationship to the design control process.  A properly-maintained DMR never becomes decoupled […]

U.S. FDA releases draft guidance on submission requirements for management of medical device cybersecurity

October 2018 U.S. FDA releases draft guidance on submission requirements for management of medical device cybersecurity… Links to the draft guidance and corresponding Federal Register notice are provided below: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM623529.pdf https://www.federalregister.gov/documents/2018/10/18/2018-22697/content-of-premarket-submissions-for-management-of-cybersecurity-in-medical-devices-draft-guidance

From the Archives: Final draft of New ISO 13485 Medical Devices Quality Management System Standard published…

October 2015   For several years ISO 13485:2003 (which is the heart of BS EN ISO 13485:2012) has been under revision. After incorporation of numerous comments and feedback from many international stakeholders, a final draft of the standard has now been released by ISO Technical Committee 210. It is expected that the final standard will […]