Your 510(k) specialists _ vision28

FDA has supplied manufacturers mechanisms through which they can request feedback from FDA regarding potential or planned medical device Investigational Device Exemption (IDE) applications, Premarket Approval (PMA) applications, Evaluation of Automatic Class III Designations (de novo petitions), or Premarket Notification (510(k)) Submissions. Database d b This is their Pre-Sub Program.

Agency advice provided prior to submission of a 510(k) may be a highly effective tool in streamlining 510(k) approval, as their advice can aid in identifying planned testing that may be unnecessary, or additional testing that may be needed for them to review your 510(k). Ads b database It is advisable to submit a Pre-Sub request:

There are specific requirements for submitting a request for a Pre-Sub, including a request for an in-person meeting, a telecom, or a written response.


Database denormalization We can help you decide which approach is best for your particular situation; complete the requisite paperwork for the request; review, edit or author the substantive request; and attend meetings or telecoms with you.

There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. Pokemon y database The Special and Abbreviated 510(k) methods were developed under the “New 510(k) Paradigm” to help streamline the 510(k) review process. Data recovery icon We can help you decide which approach is right for you, and then our experienced experts can help prepare your submission and then submit it to FDA.

Traditional 510(k)s may be used for a new device or for a modification to a previously cleared device. Fda 510 k database In this submission all test data is included in the submission and the FDA strives to complete their evaluation in 90 days. Google hacking database Special 510(k)

Special 510(k)s may be submitted for a modification to a device that already has a 510(k). Database concepts 6th edition pdf If a new 510(k) is needed per the guidance for new 510(k) requirements, and there is no modification to the intended use or the underlying technology of the device, then summary information from the design control process may serve as the basis for submission. Data recovery utility Additionally, FDA attempts to clear Special 510(k)s within 30 days, rather than the 90 days required for a Traditional 510(k) submission. Data recovery from hard drive Abbreviated 510(k)

The Abbreviated 510(k) relies on the use of guidance documents, special controls, and recognized standards. Database objects An Abbreviated 510(k) submission must include all of the elements of a traditional 510(k). Data recovery raid 5 However, in an Abbreviated 510(k) submission manufacturers provide summary reports on the use of guidance documents, special controls, or declarations of conformity to recognized standards, instead of test data, to expedite the review of a submission. Database architect We can provide you a Preliminary Regulatory Assessment which will evaluate your device against FDA regulations to determine what categorization, class, predicates and life-cycle characteristics may apply to your device. Data recovery options Using this information, we will determine a Regulatory Strategy which includes what submission strategy would be best for your situation, and what special controls, testing, guidance or recognized standards may apply.

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