- General Requirements
- Postapproval (Annual) Reports
- PMA Supplement
- Medical Device Reporting (MDR)
- Postmarket Surveillance Studies
PMA Postapproval Requirements are requirements that apply to a device after it has been approved under a Premarket Approval Application (PMA).
FDA may impose postapproval requirements in a PMA approval order, by regulation at the time of approval of the PMA or by regulation subsequent to approval. Postapproval requirements may include as a condition of approval of the device:
- restriction of the sale, distribution or use of the device [section 515(d)(1)(B)(ii) or 520(e) of the FD&C Act];
- 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 a requirement and the number of patients to be evaluated and the reports required to be submitted;
- 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 such as information provided to the patient on alternative modes of therapy and on risks and benefits associated with the use of the device;
- 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. Note: If patient identification cards are required in cases where the devices are sold directly to health practitioners, a PMA applicant`s responsibility will be to supply such cards directly to practitioners for distribution to patients and to take reasonable steps to obtain patient identity information from the practitioners.;
- 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. Note: FDA will require that the identity of any patient be disclosed in records maintained under the postapproval reporting requirements 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;
- 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;
- at specified intervals, submission of periodic reports containing the information required by §814.84(b);
- batch testing of the device;
- any other requirements determined by FDA to be necessary to provide reasonable assurance, or continued reasonable assurance, of the safety and effectiveness of the device; and
- device tracking requirements under §821, Medical Device Tracking.
An applicant must grant FDA access to any records and reports required under the provision of §814.82 and 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.
A device may not be manufactured, sterilized, packaged, stored, labeled, distributed, or advertised in a manner that is inconsistent with any conditions of approval specified in the PMA approval order for the device.
Failure to comply with any postapproval requirement constitutes a reason for withdrawing approval of a PMA.
Continued approval of the PMA is contingent upon the submission of postapproval reports (annual reports) required under §814.84 at intervals of 1 year from the date of approval of the original PMA. The annual report shall indicate the beginning and ending date of the period covered by the report and shall include the following information required by 21 CFR 814.84:
(1) Identification of changes described in §814.39(a) (PMA supplements) and changes required to be reported to FDA under §814.39(b).
(2) Bibliography and summary of the following information not previously submitted as part of the PMA and that is known to or reasonably should be known to the applicant:
- unpublished reports of data from any clinical investigations or nonclinical laboratory studies involving the device or related devices ("related" devices include devices which are the same or substantially similar to the applicant`s device); and
- reports in the scientific literature concerning the device.
If, after reviewing the summary and bibliography, FDA concludes that the agency needs a copy of unpublished or published reports, FDA will notify the applicant that copies (two copies) of such reports must be submitted.
The annual report should summarize information pertaining to the original PMA and any subsequent PMA supplements. In addition, postapproval reports for PMA supplements approved under the original PMA, if applicable, are to be included in the next and subsequent annual reports for the original PMA unless specified otherwise in the approval order for the supplement. Separate reports for individual supplements should not be submitted unless FDA requests them.
Annual Reports should be identied as "Annual Report" and include the applicable PMA reference number. Two copies should be submitted to the PMA Document Mail Center - WO66-G609, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002.
Before any change affecting the safety or effectiveness of the device can be made, the PMA holder must submit a PMA supplement to FDA for review and approval for this change. The exception is a type of change for which a "Special PMA Supplement-Changes Being Effected" is permitted under §814.39(d) or an alternate submission is permitted in accordance with §814.39(e). A PMA supplement or alternate submission shall comply with applicable requirements under §814.39 of the final rule for Premarket Approval of Medical Devices.
A PMA supplement must be submitted when unanticipated adverse effects, increases in the incidence of anticipated adverse effects, or device failures necessitate a labeling, manufacturing, or device modification. In addition, a PMA supplement must be submitted if the device is to be modified and the modified device should be subjected to animal or laboratory or clinical testing designed to determine if the modified device remains safe and effective.
Additional guidance on PMA supplements can be found in this section under "PMA Supplements and Amendments."
The holder of an approved PMA must comply with all applicable postmarket requirements required by device regulations. Please see Device Advice section on Postmarket Requirements.
The holder of a an approved PMA must comply with Medical Device Reporting (MDR) requirements described in 21CFR 803 . In addition, the PMA holder must:
- report deaths and serious injuries that a device has or may have caused or contributed to,
- establish and maintain adverse event files, and
- submit summary annual reports.
Information on MDR, including how, when, what, and where to report, is available at the following locations:
FDA may order postmarket surveillance studies to be conducted as a condition of PMA approval. FDA can order postmarket surveillance at the time of approval or at any time thereafter for any approved device if any of these circumstances are met:
- the failure of the device would be reasonably likely to have serious adverse health consequences; or
- the device is intended to be implanted in the human body for more than one year; or
- the device is expected to have significant use in pediatric populations; or
- the device is intended to be a life sustaining or life supporting device used outside a device user facility.
Manufacturers must submit a plan for approval within 30 days of receiving an order to conduct a postmarket surveillance study from FDA. After receiving the manufacturer's proposed plan, FDA has 60 days to determine if the person designated to conduct the surveillance is qualified and experienced, and if the plan will collect useful data that can reveal unforeseen adverse events or other information necessary to protect the public health.
Additional information can be found in the following sections:
- Device Advice on Postapproval Studies
- Device Advice on Postmarket Surveillance Studies
- Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act