The FDA modernized the current 21 CFR 820 regulation by incorporating ISO 13485:2016 by reference in 21 CFR 820. Do you need training?
Quality Management System Regulation (QMSR) Webinar – $79
20-Question Exam and Training Certificate available for $19.95:
When is this training webinar scheduled?
This webinar was live on Friday, February 16, 2024, but the session was also recorded. You can purchase it on-demand and watch the training as often as you wish. There are 26 slides in the presentation and the duration of the presentation is 58 minutes.
What you will receive:
- a recording of the webinar you can replay anytime
- an example of a quality plan template specifically written for the QMSR implementation
- the native slide deck for this webinar
If you would like to ask specific questions about implementing changes to your quality management system, please submit them via email or schedule a call using the calendly app on our contact us page. All deliveries of content will be sent via AWeber emails to confirmed subscribers. If you don’t receive the content automatically, please check your spam folder.
When is the FDA expected to change from 21 CFR 820 to ISO 13485?
The FDA planned to transition the quality system requirements from 21 CFR 820 to adopting ISO 13485:2016 by reference. The transition was planned for 2020, but the Covid-19 global pandemic delayed the implementation. The FDA published a final rule for the new QMSR on February 2, 2024. The FDA plans to implement amended regulations within 24 months (i.e., February 2, 2026).
What is the QMSR (the future 21 CFR 820)?
The “QMSR” is an acronym for Quality Management System Regulation. This is the FDA’s new final rule published on February 2, 2024. The FDA modernized the current 21 CFR 820 regulation by incorporating ISO 13485:2016 by reference. The final rule is a 30-page PDF document, but the sections of the regulation are now only six sub-sections that comprise two pages at the end of the PDF.
What is QSR (the current 21 CFR 820)?
21 CFR Part 820 is the FDA Current Good Manufacturing Practice (CGMP) regulation, which became effective on December 18, 1978. The regulations ensure that medical devices distributed in the US market are designed and developed with adequate procedures, people are trained, and quality records are maintained. In 1990, the FDA revised of the CGMP regulation to add the requirement for design controls (i.e., 21 CFR 820.30) authorized by the Safe Medical Devices Act. The revised regulation was released in 1996 and referred to as the Quality System Regulations (i.e., QSR). Title 21 is the section of the Code of Federal Regulations (i.e., CFR) reserved for the Food and Drug Administration (i.e., FDA) regulations.
Historical Recordings Available On-Demand
The 21 CFR 820 webinar on the old Quality System Regulations (QSR) was originally recorded on February 17, 2014. The presentation was updated and re-recorded on November 5, 2019, because the FDA planned to modernize the regulations. However, the COVID-19 pandemic delayed the FDA’s plans. The only official change to 21 CFR 820 since 2019 is a minor rewording of the “Exceptions and Variances” section 21 CFR 820.1(e) copied below with redlines.
How to Get Notification of Changes to 21 CFR 820
Please subscribe to our blog and our YouTube channel to stay current on the FDA transition to ISO 13485. We will post updates in both places in real-time.
Historical Webinar Topics include:
- Why you don’t “pass” an FDA inspection
- 12 of the 32 regulatory requirements which cause most of 483s
- The list of 23 required procedures in the Quality System regulation
- 3 ways to avoid Warning Letters
- Why you need a separate glossary for your Quality System.
- Why creating your own definitions is a bad idea…and much more
VIEW OUR PROCEDURES – CLICK HERE OR IMAGE BELOW:
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.