FDA 510K Approval:

For medical devices classified as Class II or Class III, a 510K approval is necessary in order to market the product in the US. The approval requires compliance to the Code of Federal Regulations CFRs, Part 820 Quality System Regulations (QSRs), Good Manufacturing Practices (GMP), and the other applicable regulations for the product type and indications for use (IFU). Certification Xpert can assist in the preparation and filing the 510K approval application, provide training on the GMPs, and the implementation of a quality management system in compliance with the QSRs and applicable CFRs.

NOTE: Registrars and notified bodies sometimes offer a different service called "FDA 510k Reviews". This service is limited to a review of the final draft of the submittal for FDA approval. They in NO WAY are allowed to assist or advise you on the how to prepare your submittal, nor provide training or consulting. Our services include assistance in establishing AND final review of the 510k submittal, along with any training or implementation consulting that may be necessary.

Here are some important facts about this process:

a/ Establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States (U.S.) are required to register with the FDA. This process is known as establishment registration. Registration provides FDA with the location of medical device manufacturing facilities and importers. A registration fee is under consideration by Congress.

b/ A 510k is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.

c/ A 510k requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is at least as safe and effective as the predicate.

d/ The holder of a 510k must have design control documentation available for FDA review during a site inspection. In addition, any changes to the device specifications or manufacturing processes must be made in accordance with the Quality System regulation (21 CFR 820) and may be subject to a new 510k.

e/ Please note that the FDA does not perform 510k pre-clearance facility inspections. The submitter may market the device immediately after 510k approval is granted. The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after 510k

f/ The SE determination is usually made within 90 days and is made based on the information submitted by the submitter.

g/ The Food and Drug Administration charges a one-time fee to review your 510k application. The standard FDA review fee is $3,693 and $1,847 for companies with gross receipts or sales greater than $100 million.

Certification Xpert's approach to FDA 510k Approval: Certification Xpert will prepare your Traditional, Abbreviated or Special 510k submission for FDA approval. Our services include: Developing an effective regulatory strategy for submission, product specific background research, documentation preparation (all required 510k sections) , internal expert review of your submission to minimize additional questions from the FDA, and communicating with the FDA on behalf of the client.

1/ Background research on device (i.e. classification, product code, guidance documents, standards)

2/ Predicate device(s) assessment

3/ Indications for Use Statement

4/ 510k Compilation

5/ Internal Review

6/ Formal Review of 510k with Client

7/ Submittal to FDA

Proposal or additional information Request:

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