January 31, 2024 FDA’s QMSR Final Rule Issued FDA has issued its Final Rule on its new Quality Management System Regulation (QMSR) amending its device current good manufacturing practice (CGMP) requirements of the 1996 Quality System (QS) regulation (21 CFR Part 820) to harmonize and modernize it primarily by incorporating by reference ISO […]
<h1 class="entry-title">Category: FDA QMS</h1>
Is that eQMS platform (such as SharePoint) fit for its purpose?
April 6, 2023 Is that eQMS platform (such as SharePoint) fit for its purpose? I saw a question today wondering whether SharePoint is suitable for maintaining a medical device QMS documents system and record control. In a nutshell, SharePoint (or whatever other eQMS practice is proposed) may or may not be suitable for maintaining […]
Don’t confuse FDA’s Part 11 with FDA’s software validation requirements of §820.70(i)
April 6, 2023 Don’t confuse FDA’s Part 11 with FDA’s software validation requirements of §820.70(i) I oftentimes see narratives that state or imply that FDA’s security and integrity requirements for electronic records and signatures from 21 CFR Part 11 are the same thing as FDA’s quality system or manufacturing “software validation” requirements in 21 […]
Regulatory Review of Marketing Literature and other DHF Elements
April 3, 2023 Regulatory Review of Marketing Literature and other DHF Elements Virtually all aspects of design and development are officially regulated activities, especially labeling/advertising development. Moreover, the quality management system demands that all personnel whose work can affect compliance shall be competent regarding their respective assignments. But even if sales and marketing (or other […]
Problem Containment Actions for Controlling Regulatory Impact
March 21, 2023 Problem Containment Actions for Controlling Regulatory Impact Today I received a question wrestling with the fact that problem containment actions tend to primarily focus on product containment and patient impact/risk, while not so much on containment actions aimed at controlling regulatory risk. This reminds me of ISO 13485’s deliberate distinction between […]
Quality Agreements – Ownership and Format
March 13, 2023 Quality Agreements – Ownership and Format The Quality and/or Regulatory departments need to be the primary authors of the Quality Agreement. Yet the Quality Agreement nonetheless still needs to be corporately/legally executed between the parties. Thus, the signatories should be executive officers in order to assure the Agreement has the necessary […]
DHF Documentation of Design Changes
March 13, 2023 DHF Documentation of Design Changes Neither the FDA nor ISO 13485 mandate a required format for the Design History File (DHF). Accordingly, we have latitude to decide what structure, format, and organizational approach we use to meet the basic regulatory requirements and objectives for the DHF. Accordingly, if your system does […]
FDA’s 21 CFR §820.72 Metrology Requirements vs. Test Method / Process Validation
July 29, 2021 FDA’s 21 CFR §820.72 Metrology Requirements vs. Test Method / Process Validation My experience has been that FDA views a test method as a process that produces an output. And if such output can’t be fully verified, then it must be validated. Since FDA’s 21 CFR §820.72 is not generally related […]
Risks from an Inadequate Development Process for Software
July 19, 2021 Risks from an Inadequate Development Process for Software The most fundamental reason for medical device design and development controls (e.g., ISO 13485 clause 7.3; the U.S. FDA’s 21 CFR 820.30, etc.) is to control risks that come from an inadequate development process. That fact is unequivocally true and stands in stark contrast to […]
FDA Remote Regulatory Assessment
July 16, 2021 FDA Remote Regulatory Assessment For the U.S. medical device jurisdiction, a client and I a couple weeks ago went through an FDA Remote Regulatory Assessment (RRA). Here’s a recap: FDA contacted the firm and informed them that, due to the current SARS-CoV-2 (COVID-19) situation, the FDA is conducting inspections [called […]