FDA Submission Aspects

Submission Services

Regulatory submission services for FDA and CE marking are intended to help companies get their products registered for market in key market areas. We provide consultants in the following service areas:
    • FDA 510k (premarket notification) development and submission
    • FDA PMA (premarket approval) development and submission
    • Device Classification (FDA Class I, II, III; Medical Device Directive class I, IIa, IIb, III) 
    • CE marking services, construction of technical file

    PMA (Premarket Approval) Devices:                                                            Products requiring PMAs are Class III devices or high risk devices that pose a significant risk of illness or injury, or devices found not substantially equivalent to Class I and II predicate through the 510(k) process. The PMA process is more involved and includes the submission of clinical data to support claims made for the device. The PMA is an actual approval of the device by FDA.

    Effectively, a complete set of design control documents are expected as part of the PMA submission This can be seen in “Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff”.

    510k (Premarket Notification) Devices:
    As stated by the FDA, “510(k) requires demonstration of substantial equivalence (SE). SE means that the new device is as safe and effective as the predicate device(s). A device is SE if, in comparison to a predicate device it:

    • has the same intended use as the predicate device; and
    • has the same technological characteristics as the predicate device; or
    • has different technological characteristics, that do not raise new questions of safety and effectiveness, and the sponsor demonstrates that the device is as safe and effective as the legally marketed device.”

The 510k application will utilize the many design control deliverables (except for exempt devices). Three categories of 510k’s can be used:

    • Traditional
    • Special
    • Abbreviated
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