(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:
(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.
(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.
(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.
(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.
(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.
(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.
(7) Submission to FDA at intervals specified in the approval order of periodic reports containing the information required by § 814.84(b).
(8) Batch testing of the device.
(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.
(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.
(c) Failure to comply with any postapproval requirement constitutes a ground for withdrawal of approval of a PMA.
(Approved by the Office of Management and Budget under control number 0910-0231)
[51 FR 26364, July 22, 1986, as amended at 51 FR 43344, Dec. 2, 1986]
Notes of Decisions
Brooks v. Mentor Worldwide, 985 F.3d 1272 (10th Cir. 2021).
“Similarly, the government retains the exclusive right to enforce post-approval requirements for continued testing, including the right to revoke approval for noncompliance.”
Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006).
· cites it 2× “” 21 C.F.R. § 814.82 (a). The FDA can impose such requirements either in the initial PMA approval order, by regulation at the time of PMA approval, or by regulation subsequent to approval.”
D'Agostino v. EV3, Inc., 845 F.3d 1 (1st Cir. 2016).
“In the six years since D’Agostino surfaced the alleged fraud, the FDA has apparently demanded neither recall nor relabeling of Onyx — this notwithstanding the agency’s option to impose postapproval requirements, 21 C.F.R. § 814.82 (a), its clear prerogative to suspend approval…”
A.F. v. Sorin Grp. USA, Inc., 346 F. Supp. 3d 534 (S.D. Ill. 2018).
· cites it 2× “¶¶ 10, 89 (alleging that Defendants delayed production of adverse event reports to the FDA, failed to follow up on many adverse event reports that they received, erroneously blamed most adverse events on other causes, and submitted insufficiently detailed annual reports that…”
Gravitt v. Mentor Worldwide, LLC, 289 F. Supp. 3d 877 (E.D. Ill. 2018).
· cites it 2× “"); 21 C.F.R. § 814.82 (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.”
McLaughlin v. Bayer Corp., 172 F. Supp. 3d 804 (E.D. Pa. 2016).
“§ 360e(d), and 21 C.F.R. §§ 814.82 , 861.1(b)(3)). “Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specification, manufacturing processes, labeling, or any other attribute, that would affect…”
Freed v. St. Jude Med., Inc., 364 F. Supp. 3d 343 (D. Del. 2019).
· cites it 2× “39 ) to submit a PMA supplement for any proposed labeling changes that affect the safety of the device, and its duty to submit an Adverse Reaction Report or Device Defect Report to the FDA (pursuant to 21 C.F.R. § 814.82 (a)(9) ) soon after it receives knowledge of an adverse…”
Glennen v. Allergan, Inc., 247 Cal. App. 4th 1 (Cal. Ct. App. 2016).
· cites it 2× “” ( 21 C.F.R. § 814.82 (a)(9) (2016).) These postapproval requirements can include restrictions on the sale, distribution, or use of the device, continuing reporting and recordkeeping requirements, and requirements related to labeling and advertising of the restricted device.”
Waltenburg v. St. Jude Med., Inc., 33 F. Supp. 3d 818 (W.D. Ky. 2014).
“After completing its review, the FDA may grant or deny pre-market approval, and may condition approval on adherence to performance standards, restrictions on sale and distribution, and/or compliance with other requirements.”
— 21 C.F.R. § 814.82(a) — 1 case
— 21 C.F.R. § 814.82(a)(9) — 1 case
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