Articles on how connected diagnostic devices are classified, described, and monitored, including intended use, FDA databases, recalls, postmarket surveillance, software changes, and what performance claims mean. This page lists all 8 Connected Diagnostics Evidence guides on the topic, each with its opening lines so you can pick the one that matches your question.
Connected Diagnostics Evidence is an independent publication. These guides are for education and do not replace care from a qualified professional.
Guides in this section
Postmarket Surveillance for Medical Devices: What It Is Designed to Learn
Postmarket surveillance is the FDA's ongoing monitoring of a medical device after it's already on the market, separate from the review that happened before the device was cleared or approved.
How to Read a Medical Device Safety Alert or Recall for a Connected Diagnostic Tool
A medical device safety alert or recall is an official notice, usually published by a regulator like the FDA, that a specific product has a confirmed or potential safety problem. It only applies to you if your device's exact brand name, model, and lot or serial number match the notice — not just its general category.
Clinical Decision Support or Diagnostic Device Software? How FDA Describes the Difference
Clinical decision support (CDS) software gives a health care professional information to help them make a decision, while diagnostic device software is regulated by the FDA because it analyzes medical images, signals, or data to produce a diagnostic finding on its own.
How to Use FDA Device Databases to Verify a Connected Diagnostic Claim
You can verify an FDA-related claim on a connected diagnostic device yourself, using two free public databases: the Product Classification Database, which shows a device's regulatory category, and the matching authorization database (510(k), PMA, or De Novo), which shows whether a specific product was actually reviewed.
Medical Device Intended Use and FDA Classification: A Reader’s Guide for Connected Exam Tools
Medical device intended use and FDA classification are the two legal concepts that determine what a connected exam tool — like a phone-attached camera used to look in an ear, a mouth, or under the skin — is actually designed, tested, and cleared to do. The U.S.
AI-Enabled Diagnostic Devices: Transparency Questions Before You Trust an Output
An AI-enabled diagnostic device is a piece of software or hardware that uses machine learning to help produce a health-related output — a score, a flag, or a reading — instead of relying only on fixed rules a person wrote. The U.S.
Software Changes in Connected Diagnostic Devices: Why Version and Workflow Matter
Connected diagnostic devices — digital otoscopes, phone-based skin scanners, home hearing tests, and telemedicine intake cameras — run software that changes over time.
Analytical Performance vs. Clinical Performance: What Diagnostic Device Claims Actually Mean
Analytical performance and clinical performance are two different measures of how well a diagnostic device works: one checks measurement accuracy in a lab, the other checks how well the device identifies a health condition in real patients. Confusing the two can lead you to trust a claim more than the evidence supports.