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0910-0231 198607-0910-001
Historical Active
HHS/FDA
PREMARKET APPROVAL OF MEDICAL DEVICES
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 10/20/1986
Retrieve Notice of Action (NOA) 07/23/1986
The information collection requirements set forth in 21 cfr 814 are approved under omb #0910-0231. - Under section 814.20(b)(3)(iv), applicants would only be required to report information that is actually known to the applicant. -under section 814.20(b)(3) the summary would only be required to contain brief statements of major points and would typically be no longer than 10-15 pages in length. -under section 814.20(b)(5), manufacturers would only be required to report on voluntary standards that were specifically applicable to their device, and that were developed in accord with fda's policy statement on standard development (50 f.r. 43081). upon request, fda will provide to applicants a complete list of standards meeting these criteria that are applicable to their device. -under section 814.20(b)(10), current practice would not change for labeling, and advertising (that is not labeling) would not be required to be reviewed prior to approval of the device. -under section 814.20(e) periodic reports would be limited to studies sponsored by the applicant or to which the applicant has reasonable access. -under section 814.82(a)(4), if patient i.d. cards are required in situations when devices are sold directly to health practitioners, a (continued)
  Inventory as of this Action Requested Previously Approved
09/30/1989 09/30/1989
400 0 0
492,840 0 0
0 0 0