The “Warning Letter” is considered by FDA to be the first step in the enforcement process, and a firm’s response to it may be its last chance, prior to a legal or administrative action, to adequately address a situation that FDA has concluded constitutes a violation.
This week’s Devine Guidance on 21 CFR, Part 820 – Subpart O (Statistical Techniques) is the proverbial “Final Act” in regards to the QSR. There is a plethora of data, standards, and websites that can provide useful information needed to create robust procedure(s) for establishing effective statistical control and sampling plans. Establishing robust statistical procedures will mitigate the potential receipt of a Form 483.
In this edition of Devine Guidance (DG), Dr. D will provide guidance for 21 CFR, Part 820, Subpart – M (Records), specifically 820.186 (Quality System Record). The Quality System Record, not to be confused with the Quality System Regulation, can be a document/procedure that points to where all documentation, procedures, and other records, required by the regulation are located, within the context of a device manufacturer’s quality system. The key for compiling a QSR and ongoing compliance with the QSR (y…
The Quality System Regulation (QSR), for production and process controls, (21 CFR, Part 820 – Subpart G, Section 820.70) is in the opinion of Dr. D one of the more salient requirements of the regulation.
The identification and traceability (sections 820.60 and 820.65) for products and finished medical devices, throughout the entire manufacturing process, including raw materials employed during the manufacturing process, and the subsequent sale and distribution of medical devices, are critical elements of the Quality System Regulation (QSR).
FDA is really taking medical device manufacturers to task in regards to purchasing controls and the overall management of their suppliers. According to Kimberly Trautman, FDA’s current Good Manufacturing Practices (cGMP) and Quality System Regulations (QSR) expert, suppliers providing non-conforming material are directly related to an increase in medical device recalls; which increases the need for effective quality processes to mitigate risk. As the medical device industry continues to grow in leaps and…
The control of documentation is one the fundamental cornerstones supporting the foundation needed for an effective quality system, whether compliance is to EN ISO 13485, EN ISO 9000, the Medical Device Directive, or in the case of this series of Devine Guidance articles, the Quality System Regulation (QSR).
In this fourth and final foray into Subpart C – Design Controls, Dr. D will review the last three subsections; (h) design transfer, (i) design changes, and (j) the design history file (DHF), located within section 820.30. These final three elements of design control are just as important as the previous subsections dissected as part of Devine Guidance.
The proverbial rubber meets the road when the actual execution of test protocols commences. In this edition of Devine Guidance , Dr. D will continue with his dissection of 21 CFR, Part 820; Section 820.30, subsection f (design verification) and subsection g (design validation).
I hope that the readers of DG are able to glean some useful information from Dr. D’s frequent flights of rodomontade (look it up) pertaining to the need for compliance with regulations. As I emphatically opined in the previous edition of DG, medical devices that are safe and effective are born from a robust design and development process. Although I cannot speak on behalf of the agency, it would be a subreption of the regulations if I did not continue to state the overall importance of design control fo…