21 CFR 814.112 - Filing an HDE.

§ 814.112 Filing an HDE.

(a) The filing of an HDE means that FDA has made a threshold determination that the application is sufficiently complete to permit substantive review. Within 30 days from the date an HDE is received by FDA, the agency will notify the applicant whether the application has been filed. FDA may refuse to file an HDE if any of the following applies:

(1) The application is incomplete because it does not on its face contain all the information required under § 814.104(b);

(2) FDA determines that there is a comparable device available (other than another HUD approved under this subpart or a device under an approved IDE) to treat or diagnose the disease or condition for which approval of the HUD is being sought; or

(3) The application contains an untrue statement of material fact or omits material information.

(4) The HDE is not accompanied by a statement of either certification or disclosure, or both, as required by part 54 of this chapter.

(b) The provisions contained in § 814.42(b), (c), and (d) regarding notification of filing decisions, filing dates, the start of the 75-day review period, and applicant's options in response to FDA refuse to file decisions shall apply to HDE's.

[ 61 FR 33244, June 26, 1996, as amended at 63 FR 5254, Feb. 2, 1998; 63 FR 59221, Nov. 3, 1998]

Title 21 published on 19-May-2018 03:57

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 814 after this date.

  • 2018-02-21; vol. 83 # 35 - Wednesday, February 21, 2018
    1. 83 FR 7366 - Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective February 21, 2019. See section III of this document for additional explanation of the effective date of this final rule.
      21 CFR Parts 807, 812, and 814
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