FDA 510(k) medical genetics devices include instruments and systems used for genetic analysis and molecular diagnostics. The FDA review panel code is MG.
This is a small but rapidly growing category as many genetic tests follow the PMA or De Novo pathway instead of 510(k). Current submissions include:
| Period | Avg days (cleared) |
|---|---|
| Last 2 years | - |
| All-time average (cleared) | 399d |
| Not Substantially Equivalent (denied) | 515d |
FDA review times for Medical Genetics submissions have remained consistent, averaging 399 days for cleared devices. Denied submissions averaged 515 days before receiving a Not Substantially Equivalent determination.
This page lists all 19 medical devices in the Medical Genetics specialty that have been submitted to the FDA through the 510(k) premarket notification process. Genetic testing systems, molecular diagnostics and genomic analysis tools.
This page lists 19 medical devices in the Medical Genetics specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 11 were cleared as substantially equivalent to a predicate device. Average FDA review time: 399 days. Records from 2016 to the present.
You can use this list to:
Each entry includes: device name, 510(k) number, product code, manufacturer and FDA decision date. Click any device to view the full submission details.
This information is based on publicly available FDA data and is intended for informational purposes only. It may not reflect current market or regulatory status. Always verify critical information at accessdata.fda.gov.