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In the United States, the development and marketing of commercial tests are regulated by the U.S. Food and Drug Administration (FDA). They are considered "medical devices" and, specifically, "in vitro diagnostic devices (IVD)."   As such, they must be evaluated and approved by the FDA.A medical device is an in vitro diagnostic medical device (IVD) if it is a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic goods for in vitro use.

According to FDA, IVD product are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body [21 CFR 809.3].

Regulatory Authority: IVDs are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act, and may also be biological products subject to section 351 of the Public Health Service Act. Like other medical devices, IVDs are subject to premarket and postmarket controls. IVDs are generally also subject to categorization under the Clinical Laboratory Improvement Amendments (CLIA '88) of 1988. 

STS Diagnostic Consulting team offers effective FDA regulatory support for all sizes of firms, from small, start-up medical device companies to large, multi-divisional corporations. Our team of experts offer fully tailored solution to address particular needs.  Our FDA consulting and project management teams coordinate efforts to deliver your services on time and within budget. We maintain constant accessibility and support both on- and off-site during the course of your FDA consulting project.

We offer

  • 510(k) submissions for obtaining FDA clearance
  • Investigational Device Exemption (IDE) submissions for US clinical studies
  • Requests for Classification and Requests for Determination
  • Pre-Submission (Pre-sub) meetings
  • QSR Consulting (21 CFR Part 820) for medical device and IVD manufacturers
  • US Agent representation for manufacturers based outside the US
  • QSR training for medical device companies
  • QSR (21 CFR Part 820) audits for medical device companies and their suppliers
  • Form 483 Warning Letter analysis, response, and recovery
  • General regulatory and quality system assistance and training