Search:
(clear)
- Alpha Test
- App
- Architecture
- Artificial Intelligence
- Beta Test
- Big Data
- Biologics
- Biomarker
- BLA
- Clinical Decision Support
- Clinical Development
- CMS
- Combination Product
- Compliance
- Device
- Diagnostic
- Digital Healthcare
- Disease Management
- DRGs
- Drug
- EMA
- FDA
- LIMS
- Machine Learning
- MDDS
- mHealth
- NDA
- Payer
- Personalized Medicine
- Phase I Trial
- Phase II Trials
- Phase III Trials
- Phase IV Trials
- Picture Archiving (PICS)
- PMA
- Polymorphism
- Population Health
- Precision Medicine
- Provider
- Quantified Self
- SaaS
- Sequence
- SNP
- Telehealth
- Translational Medicine
- UX
An application or purpose-built software. Regulation of software by the FDA is still evolving, but developers should anticipate the need for rigorous validation and FDA regulation if an App is provided as an extension of a regulated device, or if the app functions as a platform for a regulated device or service. Apps used in an evidentiary capacity in clinical trials may also enjoin regulatory scrutiny.