Ahead of the proposed shift away from the current US Food and Drug Administration (FDA) quality management system (QMS) CFR 21 Part 820 regulation toward ISO 13485:2016, a new white paper sheds light on how the action will impact medical device development.
The white paper identified three interrelated principles that will define the direction of the agency’s process, which has yet to be clearly defined, after the transition. These principles relate to the concept of safety by product design, FDA’s safety/effectiveness gold standard and least burdensome principles.
“FDA is more likely to enact changes that promote, maintain or improve safety and effectiveness for users and patients that do not result in significantly more burden for both themselves and the industry,” according to the white paper from Massachusetts-based software firm Cognition Corporation. “More explicit requirements for design controls might fall under this umbrella, and therefore need to be understood as a real concern for manufacturers to prepare for.”
The standard was revised with the total product lifecycle (TPLC) approach in mind. As such, FDA is expected to expand on risk management regulations to better incorporate the TPLC vision.
Cognition issued the second white paper of its two-part series Tuesday on the impact of the transition from FDA’s regulations to the globally-agreed upon standard for medical devices quality management systems. The first white paper from January largely focused on major changes to previously harmonized requirements that the 2016 revision of the International Organization for Standardization (ISO) standard introduced, whereas the second white paper is specifically targeted at the correlation between FDA’s regulation and ISO 13485:2016.
Both white papers were developed based on an analysis of the old and the revised versions of ISO 13485 as well as the text of CFR 21 Part 820, authored by NSF International’s executive vice president of medical device international services Kim Trautman while employed by FDA. Trautman previously told Focus each subsequent version of 13485 brought greater convergence of regulations, particularly the 2016 edition, and FDA “has the right intention” to continuing driving the trend via the shift…