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Regulatory Insight has extensive experience negotiating the optimal approach to obtaining market approval or clearance for a specific medical device or IVD with the U.S. Food and Drug Administration. This translates directly into cost savings and faster time to market for a company’s product(s).

FDA classifies medical devices in the United States as Class I, II or III. However, it is far more complicated than that. Most Class I devices are 510(k)-exempt, but not all. Most Class II devices require a 510(k), but some are 510(k)-exempt. Some Class III devices require a PMA and some only require a 510(k).

Novel devices are often classified by the FDA as Class III simply because there is no predicate device. However, Section 513(f) of the Food, Drug and Cosmetic Act allows the sponsor of a novel device to submit a de novo application for potential reclassification of their novel Class III device to a Class I or II device, eliminating the need for a costly and time-consuming PMA.

Regulatory Insight specializes in the following types of U.S. FDA regulatory submissions:

510(k)s Premarket Notifications (including Abbreviated
510(k)s & Special 510(k)s)
PMA Premarket Approval Applications (including PMA Supplements)
De Novo Applications
Establishment Registrations and Device Listings
Product Reports for Radiation Health
513(g) Requests for Classification Information
RFD Requests for Designation Submissions to the Office of Combination Products


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Regulatory Insight, Inc. | 5401 S. Cottonwood Ct., Greenwood Village, CO 80121 U.S.A. | +1-720-962-5412 | info@reginsight.com

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510(k) * FDA Compliance * Medical Device Submissions * Regulatory Insight * Regulatory Compliance
and Market Clearance for Medical Device & IVD Companies

Regulatory Insight * Specializing in FDA Registration & FDA Compliance. FDA and Medical Device Consulting.

Comprehensive worlwide regulatory consulting services.

FDA PMA Premarket Approval FDA 510(k) Premarket Clearance
FDA and other regulatory body accepted clinical studies
FDA Establishment Registration and Device Listing
Health Canada Medical Device and Establishment License
FDA classifies medical devices in the United States as Class I, II or III. However, it is far more complicated than that.
Most Class I devices are 510(k)-exempt, but not all. Most Class II devices require a 510(k), but some are 510(k)-exempt.
Some Class III devices require a PMA and some only require a 510(k).

FDA Registration Consultants * FDA Compliance Consultants * 510(k) Submissions

FDA Registration Consultants | FDA Compliance Consultants | FDA Submissions | FDA Compliance | Medical Device Consulting | Training | Imports/Exports | Contact