§ 814.82 Postapproval requirements., 21 C.F.R. § 814.82
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`Code of Federal Regulations
`Title 21. Food and Drugs
`Chapter I. Food and Drug Administration, Department of Health and Human Services (Refs & Annos)
`Subchapter H. Medical Devices
`Part 814. Premarket Approval of Medical Devices (Refs & Annos)
`Subpart E. Postapproval Requirements
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`21 C.F.R. § 814.82
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`§ 814.82 Postapproval requirements.
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`Currentness
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`(a) FDA may impose postapproval requirements in a PMA approval order or by regulation at the time of approval of the PMA
`or by regulation subsequent to approval. Postapproval requirements may include as a condition to approval of the device:
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`(1) Restriction of the sale, distribution, or use of the device as provided by section 515(d)(1)(B)(ii) or 520(e) of the act.
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`(2) Continuing evaluation and periodic reporting on the safety, effectiveness, and reliability of the device for its intended
`use. FDA will state in the PMA approval order the reason or purpose for such requirement and the number of patients to
`be evaluated and the reports required to be submitted.
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`(3) Prominent display in the labeling of a device and in the advertising of any restricted device of warnings, hazards, or
`precautions important for the device's safe and effective use, including patient information, e.g., information provided to
`the patient on alternative modes of therapy and on risks and benefits associated with the use of the device.
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`(4) Inclusion of identification codes on the device or its labeling, or in the case of an implant, on cards given to patients
`if necessary to protect the public health.
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`(5) Maintenance of records that will enable the applicant to submit to FDA information needed to trace patients if such
`information is necessary to protect the public health. Under section 519(a)(4) of the act, FDA will require that the identity
`of any patient be disclosed in records maintained under this paragraph only to the extent required for the medical welfare of
`the individual, to determine the safety or effectiveness of the device, or to verify a record, report, or information submitted
`to the agency.
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`(6) Maintenance of records for specified periods of time and organization and indexing of records into identifiable files to
`enable FDA to determine whether there is reasonable assurance of the continued safety and effectiveness of the device.
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`(7) Submission to FDA at intervals specified in the approval order of periodic reports containing the information required
`by § 814.84(b).
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`(8) Batch testing of the device.
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` © 2015 Thomson Reuters. No claim to original U.S. Government Works.
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`§ 814.82 Postapproval requirements., 21 C.F.R. § 814.82
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`(9) Such other requirements as FDA determines are necessary to provide reasonable assurance, or continued reasonable
`assurance, of the safety and effectiveness of the device.
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`(b) An applicant shall grant to FDA access to any records and reports required under the provisions of this part, and shall
`permit authorized FDA employees to copy and verify such records and reports and to inspect at a reasonable time and in a
`reasonable manner all manufacturing facilities to verify that the device is being manufactured, stored, labeled, and shipped
`under approved conditions.
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`(c) Failure to comply with any postapproval requirement constitutes a ground for withdrawal of approval of a PMA.
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`(Approved by the Office of Management and Budget under control number 0910–0231)
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`Credits
`[51 FR 43344, Dec. 2, 1986]
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`SOURCE: 51 FR 26364, July 22, 1986; 51 FR 43344, Dec. 2, 1986; 54 FR 39641, Sept. 27, 1989; 61 FR 51531, Nov. 1, 1996;
`62 FR 51520, Oct. 1, 1997, unless otherwise noted.
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`AUTHORITY: 21 U.S.C. 351, 352, 353, 360, 360c–360j, 371, 372, 373, 374, 375, 379, 379e, 381.
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`Notes of Decisions (112)
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`Current through Dec. 3, 2015; 80 FR 75638.
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`End of Document
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`© 2015 Thomson Reuters. No claim to original U.S. Government Works.
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` © 2015 Thomson Reuters. No claim to original U.S. Government Works.
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`Ex. 2031-0002