Evaluation of Automatic Class III Designation (De Novo) Summaries (CBER)
The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo classification option as an alternate pathway to classify novel medical devices that had automatically been placed in Class III after receiving a "not substantially equivalent" (NSE) determination in response to a premarket notification [510(k)] submission. Section 513(f)(2) of the FD&C Act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA), on July 9, 2012, to allow a sponsor to submit a De Novo classification request to the FDA for without first being required to submit a 510(k).
There are two options for De Novo classification for novel devices of low to moderate risk.
- Option 1: Any person who receives an NSE determination in response to a 510(k) submission may, within 30 days of receipt of the NSE determination, submit a De Novo request for the FDA to make a risk-based evaluation for classification of the device into Class I or II.
- Option 2: Any person who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may submit a De Novo request for the FDA to make a risk-based classification of the device into Class I or II, without first submitting a 510(k) and receiving an NSE determination.
Devices that are classified through the de novo process may be marketed and used as predicates for future 510(k) submissions.
Since 2010, the FDA has begun releasing summary documents for devices classified through the De Novo process. The De Novo summary is intended to present an objective and balanced summary of the scientific evidence that served as the basis for the decision to grant a De Novo request. The De Novo summary also serves as a resource regarding the types of information necessary to support substantial equivalence for device manufacturers that may wish to use the device as a predicate for future 510(k) submissions.
Links to all available De Novo summary documents can be found in the table below.
|De Novo Number||Applicant||Device Name||Decision Date|
|BR220737||One Lambda Inc.||SeCoreTM CDx HLA Sequencing System||11/28/2022|
|BR190330||Vela Diagnostics USA Inc.||Sentosa SQ HIV-1 Genotyping Assay||11/5/2019|
|BK060036||Biosafe SA||Sepax Cell Separation System and single use kits||1/3/2007|
|BK000038||Visible Genetics, Inc.||TRUEGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System||9/26/2001|
- De Novo Classification Request
- De Novo Classification Process (Evaluation of Automatic Class III Designation) - Guidance for Industry and Food and Drug Administration Staff
- User Fees and Refunds for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff
- FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff
- Acceptance Review for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff
- Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications - Guidance for Industry and FDA Staff
- Evaluation of Automatic Class III Designation (De Novo) Summaries
- CDRH Learn Module - De Novo Program
- Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions
- De Novo Classification Requests Database