Source: https://www.federalregister.gov/documents/2010/08/11/2010-19746/agency-information-collection-activities-submission-for-office-of-management-and-budget-review
Timestamp: 2017-08-18 04:21:00
Document Index: 569875087

Matched Legal Cases: ['art 807', 'art 807', '§\u2009807', '§\u2009807', '§\u2009807', '§\u2009807', '§\u2009807', '§\u2009807', '§\u2009807']

Federal Register :: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification
A Notice by the Food and Drug Administration on 08/11/2010
Fax written comments on the collection of information by September 10, 2010.
75 FR 48696
48696-48697 (2 pages)
Docket No. FDA-2010-N-0198
2010-19746
Premarket Notification—(OMB Control Number 0910-0120)—Extension
https://www.federalregister.gov/d/2010-19746 https://www.federalregister.gov/d/2010-19746
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0120. Also include the FDA docket number found in brackets in the heading of this document.
Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(k)) and the implementing regulation under part 807 (21 CFR part 807, subpart E) requires a person who intends to market a medical device to submit a premarket notification submission to FDA at least 90 days before proposing to begin the introduction, or delivery for introduction into interstate commerce, for commercial distribution of a device intended for human use. Based on the information provided in the notification, FDA must determine whether the new device is substantially equivalent to a legally marketed device, as defined in § 807.92(a)(3). If the device is determined to be not substantially equivalent to a legally marketed device, it must have an approved premarket approval application (PMA), Product Development Protocol, Humanitarian Device Exemption (HDE), Petition for Evaluation of Automatic Class III Designation (de novo) or be reclassified Start Printed Page 48697into class I or class II before being marketed. FDA makes the final decision of whether a device is substantially equivalent or not equivalent.
Introducing a device into commercial distribution for the first time by a person who is required to register; and
Section 204 of the Food and Drug Administration Modernization Act (FDAMA) amended section 514 of the act (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions including premarket notifications or other requirements. FDA has published and updated the list of recognized standards regularly since enactment of FDAMA and has allowed 510(k) submitters to certify conformance to recognized standards to meet the requirements of § 807.87. FDA Form FDA 3654, the 510(k) Standards Data Form, standardizes the format for submitting information on consensus standards that a 510(k) submitter chooses to use as a portion of their premarket notification submission (The Form FDA 3654 is not for declarations of conformance to a recognized standard). FDA believes that use of this form will simplify the 510(k) preparation and review process for 510(k).
Form FDA 3514, a summary coversheet form, assists respondents in categorizing administrative 510(k) information for submission to FDA. This form also assists respondents in categorizing information for other FDA medical device programs such as PMAs, investigational device exemptions, and HDEs. Under § 807.87(h), each 510(k) submitter must include in the 510(k) either a summary of the information in the 510(k) as required by § 807.92 (510(k) summary) or a statement certifying that the submitter will make available upon request the information in the 510(k) with certain exceptions as per § 807.93 (510(k) statement). If the 510(k) submitter includes a 510(k) statement in the 510(k) submission, § 807.93 requires that the official correspondent of the firm make available within 30 days of a request, all information included in the submitted premarket notification on safety and effectiveness. This information will be provided to any person within 30 days of a request if the device described in the 510(k) submission is determined to be substantially equivalent. The information provided will be a duplicate of the 510(k) submission including any safety and effectiveness information, but excluding all patient identifiers and trade secret and commercial confidential information. According to § 807.90, submitters may request information on their 510(k) review status 90 days after the initial log-in date of the 510(k). Thereafter, the submitter may request status reports every 30 days following the initial status request. To obtain a 510(k) status report, the submitter should complete the status request form, Form FDA 3541, and fax it to the Center for Devices and Radiological Health office identified on the form. The most likely respondents to this information collection will be specification developers and medical device manufacturers.
In the Federal Register of May 5, 2010 (75 FR 24708), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
807 subpart E 3,800 1 3,800 79 300,200
807.87 FDA Form 3514 1,956 1 1,956 0.5 978
807.90 (a)(3) FDA Form 3541 218 1 218 0.25 55
807.87(d) and (f) FDA Form 3654 1,500 1 1,500 10 15,000
807.92 and 807.93 2,000 10 2,000 10 20,000
Total 336,233
[FR Doc. 2010-19746 Filed 8-10-10; 8:45 am]