In this edition of Devine Guidance (DG), Dr. D will provide guidance for 21 CFR, Part 820, Subpart – M (Records), specifically 820.180 (General Requirements). General requirements are boring; however, just like basic blocking and tackling drills in football, device manufacturers must get the basics correct.
In this edition of Devine Guidance , Dr. D provides guidance for 21 CFR, Part 820 – Subpart – J, Corrective and Preventive Action (CAPA), specifically (820.100). A strong CAPA system will allow organizations to track quality problems to closure. CAPA is not rocket science: you identify problems and you fix problems.
On July 19 and 20, 2010, the Food and Drug Administration held a public meeting on regulatory oversight of laboratory-developed tests (LDTs). This is considered a major step in an ongoing debate on how best to handle two different, but often overlapping, sets of diagnostic tools in a manner that best serves patient safety and public health, while recognizing the realities of clinical practice and medical product development.
Stakeholder interest was intense. The original meeting space reached capacity and registration closed within two days, prompting FDA to shift the conference to a larger venue. Nearly 650 people attended, while 650 more watched via webcast. FDA’s sense of urgency on the matter was further suggested by the June 10 issuance of “it has come to our attention” letters to six genetic testing companies, followed by another 14 on the opening day of the conference itself.
What are the issues? Why the concern? What does it all mean, and where might the Agency go?
The evaluation and management of risk throughout the product life cycle is the single most important concept in the regulation of medical devices. Yet it is difficult to define precisely what “risk” means or how to assess it in an industry where some 115,000 devices are produced by thousands of manufacturers, employing a dizzying array of technologies destined for use in varying health settings for every imaginable indication. So who determines the risk, and where do problems typically arise?
Welcome back to this sixth installment of Devine Guidance . I am not one to assume a Panglossian view (time to pull out the dictionary again) when dealing with problem suppliers and the need to pursue corrective action. However, at times the ugly SCAR becomes unavoidable. In fact, evidence of effective corrective action, as it pertains to suppliers is a requirement and the FDA, notified bodies, and other regulatory bodies will verify the effectiveness of the approach pursued by your organization. Additi…
If you are a returning visitor, welcome back to this 4th installment of Devine Guidance. If this is your first time, I hope you have a chance to read the first-three installments of my blog. In this installment, I will continue with the defensive-receiving inspection theme, a process that I feel “has limited-value.” That said,…
To those who have decided to return for another episode of Devine Guidance , thank you! Once again, I hope you find some reading enjoyment and value in this third installment. For this adventure, I plan to dive into the importance of a clear and concise specification to support the design, development, and procurement processes.