De Novo Classification Process in the Final Rule Stage

This content is only available to our Premium subscribers.  See our Subscribe page for information on subscriptions.

 

The agency rule list for Spring 2020, accessible at https://www.reginfo.gov/public, announced that the “Medical Device De Novo Classification Process” rule is in the final rule stage. Although the FDA has previously written a guidance document about the De Novo process, they are taking the more formal step of agency rule-making regarding the topic as well. The abstract says the upcoming final rule “would establish procedures and criteria for the De Novo process and would make it more transparent and predictable for manufacturers.”

 

The FDA initially proposed this rule on the De Novo process in December 2018 – read the proposed rule in the Federal Register here: Proposed De Novo Rule. In the proposed rule, the FDA sought to “establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act.” The purpose of the proposed rule was consistent with what is already understood about the De Novo classification process:

  1. A manufacturer may submit a De Novo request after receiving a NSE determination in response to a 510(k) submission, or
  2. A manufacturer may submit a De Novo request as their first submission because they have determined there is no substantially equivalent device.

In Latin, the phrase “de novo” means “from the new” – so, it makes sense that De Novo requests allow the FDA to classify novel devices as Class I or II. Then, subsequent submissions for a device of the same type may rely on the De Novo determination as a predicate device for a substantial equivalence decision.

 

The December 2018 proposed rule suggested a more standardized process for De Novo requests – requiring the submission of “administrative information, regulatory history, device description [including intended use], classification summary information, benefits and risks of device use, and performance data to demonstrate reasonable assurance of safety and effectiveness.” It seems that when this rule becomes final (likely sometime soon, as it is in the final stages of rulemaking), there will be a clear format for the document that device manufacturers need to submit to the FDA if they want to receive De Novo classification. We will be sure to update our readers when the rule is final. We expect to see an Appendix which details what these more formal De Novo requests should look like for a regulatory submission to the FDA.

 

Read our previous posts about De Novo requests: FDA Final De Novo Submission GuidanceFDA De Novo Summaries and Submissions

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  TBD

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

TBD

 


 

Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

Registration Link:

Register Now

 


 

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.