This ICR collects information from persons who intend to market a medical device. Based on the information provided in the premarket notification (510(k)) submission, FDA determines whether a new device provides reasonable assurance of the safety and effectiveness of the device through substantial equivalence to a legally marketed device and whether the device can, therefore, be allowed to enter the U.S. market. Because the review of 510(k) submissions confirms that the new device is as safe and as effective as legally marketed predicate devices, potentially unsafe and/or ineffective devices, including those with fraudulent claims, are prevented from entering the U.S. market.
We have adjusted the number of responses to reflect current data and trends. In addition, the burden estimate has been updated consistent with new and amended provisions. We corrected the burden table to include a line for the "510(k) summary" under 21 CFR 807.92 which was inadvertently omitted from the previous ICR submission. We are making available form FDA 3881 noting that the information on this form was already approved under the previous ICR submission. Form FDA 3514 was revised and reformatted to improve usability and to be inclusive of the majority of medical device product submission types. The revisions made to this form eliminates the need for form FDA 3654. Form FDA 3541 was removed from this ICR and the burden adjusted accordingly. To this ICR we add the availability of the eSTAR forms FDA 4062 and FDA 4078 (for IVD 510(k) to facilitate the preparation of submissions in electronic format. Additionally, we are revising this ICR to include two guidance documents, "Refuse to Accept Policy for 510(k)s" and, "Request for Recogniction of a Voluntary Consensus Standard." Further details on these updates, revisions and adjustments may be found in item A15 of the supporting statement.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Premarket Notification Submission 510(k), Subpart E