Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals

Postapproval Requirements

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.

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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:

1. 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
2. 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.

When any significant chemical, physical or other change or deterioration in the device or any failure of the device to meet the specifications established in the approved PMA are correctable by adjustments or other maintenance procedures described in the approved labeling, all such events known to the applicant shall be included in the Annual Report unless specified otherwise in the conditions of approval to the PMA. The annual report shall appropriately categorize these events and include the number of reported and otherwise known instances of each category during the reporting period. Additional information regarding these events shall be submitted by the applicant when determined by FDA to be necessary to provide continued reasonable assurance of the safety and effectiveness of the device for its intended use. See Adverse Reaction and Device Defect Reporting for additional reporting requirements.

Annual Reports should be identied as "Annual Report" and include the applicable PMA reference number. Two copies should be submitted to the Document Mail Center (HFZ-401), Center for Devices and Radiological Health, Food and Drug Administration, 9200 Corporate Blvd., Rockville, Maryland 20850.

FDA may order postmarket surveillance studies to be conducted as a condition of PMA approval. The FDA can order postmarket surveillance for any Class II or Class III device:

• the failure of which would be reasonably likely to have serious adverse health consequences; or
• which is intended to be implanted in the human body for more than one year; or
• which 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 documents.

Guidance on Criteria and Approaches for Postmarket Surveillance
http://www.fda.gov/cdrh/modact/critappr.pdf

Guidance on Procedures for Review of Postmarket Surveillance Submissions
http://www.fda.gov/cdrh/modact/postsurv.html
http://www.fda.gov/cdrh/modact/postsurv.pdf

Guidance on Procedures to Determine Application of Postmarket Surveillance Strategies
http://www.fda.gov/cdrh/modact/postmrk.html
http://www.fda.gov/cdrh/modact/postmrk.pdf

SMDA to FDAMA: Guidance on FDA`s Transition Plan for Existing Postmarket Surveillance
http://www.fda.gov/cdrh/modact/smdatran.html
http://www.fda.gov/cdrh/modact/smdatran.pdf

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Adverse Reaction and Device Defect Reporting [814.82(a)(9)]

FDA has determined that in order to provide continued reasonable assurance of the safety and effectiveness of the device, the applicant shall submit an "Adverse Reaction Report" or "Device Defect Report," as applicable, within 10 days after the applicant receives or has knowledge of information concerning:

(1) A mixup of the device or its labeling with another article.

(2) Any adverse reaction, side effect, injury, toxicity, or sensitivity reaction that is attributable to the device and

(a) has not been addressed by the device`s labeling or

(b) has been addressed by the device`s labeling, but is occurring with unexpected severity or frequency.

(3) Any significant chemical, physical or other change or deterioration in the device or any failure of the device to meet the specifications established in the approved PMA that could not cause or contribute to death or serious injury but are not correctable by adjustments or other maintenance procedures described in the approved labeling. The report shall include a discussion of the applicant`s assessment of the change, deterioration or failure and any proposed or implemented corrective action by the applicant. When such events are correctable by adjustments or other maintenance procedures described in the approved labeling, all such events known to the applicant shall be included in the Annual Report described under "Postapproval Reports" above unless specified otherwise in the conditions of approval to this PMA. The postapproval report shall appropriately categorize these events and include the number of reported and otherwise known instances of each category during the reporting period. Additional information regarding the events discussed above shall be submitted by the applicant when determined by FDA to be necessary to provide continued reasonable assurance of the safety and effectiveness of the device for its intended use.

Three copies of the written report identified with the PMA reference number and "Adverse Reaction Report" or "Device Defect Report," as applicable, must be submitted within 10 days after the applicant receives or has knowledge of information concerning the event. The report should be mailed to:

PMA Document Mail Center (HFZ-401),
Center for Devices and Radiological Health,
Food and Drug Administration,
9200 Corporate Blvd.,
Rockville, Maryland 20850

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The Medical Device Reporting (MDR) Regulation (21 CFR 803) requires that all manufacturers report to FDA whenever a device:

(1) may have caused or contributed to a death or serious injury or

(2) has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

The same events subject to reporting under the MDR Regulation may also be subject to the above "Adverse Reaction and Device Defect Reporting" requirements in the "Conditions of Approval" for the PMA. FDA has determined that such duplicative reporting is unnecessary. Whenever an event involving a device is subject to reporting under both the MDR Regulation and the "Adverse Reaction Report" or "Device Defect Report" condition of approval for the PMA, the applicant must submit the report on the MedWatch form as required by the MDR Regulation with the PMA reference number. Additional information on MDR including guidance documents can be found on the Internet at http:www.fda.gov/cdrh/mdr

Reports made under the MDR Regulation must be identified as MDR reported events in the periodic (annual) report to the PMA to prevent duplicative entry into FDA information systems.

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Premarket Approval Application (PMA) Supplement.

Before making any change affecting the safety or effectiveness of the device, a PMA supplement for review and approval by FDA must be submitted unless the change is of a type 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."

21 CFR 814 Subpart E (§ 814.80, § 814.82, § 814.84)

Section 522 of the FD&C Act

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Updated 11/1/2002

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