Medical Device Regulation Basics: US FDA Denovo Classification

FD&C Act Medical Device Amendments (1976) Section 513(f)(1): “new devices”

· Automatically classified as Class III regardless of risk

FD&C Act –modified in 1997 Food and Drug Administration Modernization Act (FDAMA)

· Established de novo classification process and also known as “Evaluation of Automatic Class III Designation”.
· Pathway for classification of low-risk devices when there is no predicate.

Application process

1.510(k) Submission:

· Sponsor submits 501(k) and FDA issues a decision of “not substantially equivalent” due to no predicate

2. De novo request:

· Sponsor submits de novo request and FDA classify device from Class III to Class I or II with new classification/regulation

FD&C Act –further modified in 2012 Food and Drug Administration Safety and Innovation Act (FDASIA)

· Established direct de novo classification process .There is no 510(k) submission is required.Sponser can submit directly if there is no predicate

Common denovo submission documents are listed below

1.      Coversheet clearly identifying the request as a "Request for Evaluation of Automatic Class III Designation" under 513(f)(2) De Novo request
2.      Administrative Information including applicant name and address
3.      Regulatory History
4.      Device Description, including technology, proposed conditions of use, accessory, components, etc
5.      Classification Summary
6.      Recommended Classification and Proposed Special Controls for Class II devices ONLY
7.      Supportive Evidence pre-clinical, animal, clinical
8.      Summary of Benefits
9.      Summary of Known/Potential Risks to Health
10.   Risk and Mitigation Information
11.   Benefit-Risk Considerations
12.   Device Labelling

FDA Review - 150 review days

1.Sponsor submits the application.use the acceptance review checklist guidance https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-classification-requests

2.FDA Acceptance Review :Administrative review to assess the completeness of the application.

Within 15 calendar days FDA will notify below to manufacturer:

Request accepted for substantive review;
Not been accepted for review (i.e., considered refused to accept RTA -Manufacturer shall address within 180 days
Request is under substantive review and the FDA did not complete the acceptance review within 15 calendar day

3. Substantive Review:Lead reviewer will assess the application and share the below information to manufacturer