Materials from FDA

CDRH Learn On demand webinars and other training resouces straight from FDA

FDA Guidance Database FDA's interpretation of medical device regulations

Details of IVDs (and other medical devices) already on the market

Enter the name of the device you're looking for at one of these databases

510(k)’s (Premarket Notifications)

PMAs (Premarket Approvals)

De Novos (Device Classification Under Section 513(f)(2))

Medical Device Recalls

Standards translate regulations into practical steps 

Recognized Consensus Standards: Medical Devices This database identifies standards endorsed by FDA

FDA’s list of recognized consensus standards for IVDs most often includes those published by the following organizations. These groups develop the technical and quality standards that FDA cites for assay performance, safety, and compliance.

CLSI (Clinical and Laboratory Standards Institute)
ANSI (American National Standards Institute)

ISO (International Organization for Standardization)

IEC (International Electrotechnical Commission)
ASTM International (Advancing Standards Tranforming Markets)

Need to check a standard without purchasing?

ANSI Standards Connect (Read-Only) Provides free read-only (no download, no print) access to many ISO, IEC, ASTM, and other standards 

ISO13485 and ISO14971 are viewable here along with many others.

Profession and industry resources

RAPS (Regulatory Affairs Professionals Society)

Global professional society for regulatory professionals, with certifications and training. Local chapters worldwide.

ADLM (Association for Diagnostics & Laboratory Medicine, formerly AACC)  

Professional society focused on clinical chemistry, diagnostics, and laboratory medicine, with strong clinical, academic, and industry participation (laboratorians and assay manufacturers). Local chapters nationwide.

CLSI (Clinical and Laboratory Standards Institute)

CLSI publishes widely used consensus standards for diagnostic assay evaluation and lab practice, but depends on the expertise and participation of its member laboratory professionals and IVD manufacturers. CLSI also provides free and paid trainings.

MDIC (Medical Device Innovation Consortium) 

A public–private partnership with FDA and industry, focused on advancing regulatory science, developing frameworks (e.g., clinical trial designs, real-world evidence, patient-centered benefit–risk), and accelerating safe innovation in medical devices and diagnostics.

AdvaMed 

U.S. trade association representing medical technology companies, including diagnostics. Strong in policy, advocacy, and regulatory affairs at the federal level (FDA, CMS, Congress).