November 12, 2024 FDA 483 Responses: How to Avoid a Warning Letter A firm’s proper actions in response to receiving a Form FDA 483 (“FDA 483”) is a broad subject that we can do training on for hours or even days. Thus, it may not be possible to cover all of the details […]
<h1 class="entry-title">Category: FDA</h1>
FDA’s QMSR Final Rule Issued
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 […]
U.S. FDA 510(k) Clinical Data Requirements
January 19, 2024 U.S. FDA 510(k) Clinical Data Requirements I always reminded clients that clinical data may not be required at all for a 510(k) subject device even though clinical data may have been required for the predicate. A pre-sub(s) is generally a good idea and in all parties’ best interest for unusual […]
Difficulty Submitting Part 806 Report via FDA’s ESG Gateway
December 12, 2023 Difficulty Submitting Part 806 Report via FDA’s ESG Gateway If for various reasons you are unable to submit your FDA Part 806 Report of Correction or Removal via FDA’s ESG Gateway, then another option is to have a third party submit your 806 report using the third party’s active ESG […]
Responding to a Form FDA 483
December 6, 2023 Responding to a Form FDA 483 One of my favorite types of work is responding to a Form FDA 483. The specific nature and extent of an FDA 483 Observation(s) will influence FDA’s ultimate expectations for the response. Thus, I will always need to see the exact Observation(s) to […]
“Declaration of Conformity” vs. “Certification of Conformity”
April 24, 2023 “Declaration of Conformity” vs. “Certification of Conformity” There are different kinds of declarations and certifications germane to the medical devices sector. And there is a proper distinction to be made between “declaration” and “certification”. I give my further interpretations about that herein. Ultimately, the precise context of each given scenario […]
External Documents Kept on an Externally-Controlled Server
April 21, 2023 External Documents Kept on an Externally-Controlled Server I know of no regulations or standards specifically demanding an “internal” copy of standards or country regulations. Instead, the logistics of this are generally left to our discretion. I elaborate further below. Let’s start with ISO 13485 / EN ISO 13485 (as amended […]
UDI for IVD Devices Used In-House: Part 3
April 13, 2023 UDI for IVD Devices Used In-House: Part 3 For those that would say that the part of an IVD assay/test used only in a manufacturer’s in-house lab isn’t in “commercial distribution” and thus asserting that UDI requirements don’t apply: That is definitely a thought provoking stance. But I’m thinking that such […]
Use of Off-Label Clinical Data in Premarket Submissions
April 13, 2023 Use of Off-Label Clinical Data in Premarket Submissions The supporting clinical data for a U.S. 510(k) notification (or other U.S. premarket submission) must generally meet FDA’s standard for “valid scientific evidence”. Specifically, that means (21 CFR 860.7) evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched […]
UDI for IVD Devices Used In-House: Part 2
April 13, 2023 UDI for IVD Devices Used In-House: Part 2 Once the reagent kit components (i.e., essential parts of the finished IVD device) of an IVD are sent to the healthcare facility for clinical use, then the finished IVD is in commercial distribution (thus triggering the UDI requirements) as I understand it. Also, […]