Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff | Guideline Explorer

Description

Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides the Food and Drug Administration (FDA) with the authority to require manufacturers to conduct postmarket surveillance at the time of approval or clearance or at any time thereafter of certain class II or class III devices. Postmarket surveillance is the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device. The data collected under a surveillance order help to address important public health questions on the safety and effectiveness of a device. The purpose of this guidance document is to assist manufacturers of devices subject to section 522 postmarket surveillance orders (522 orders) by providing information on how to fulfill section 522 obligations. The final guidance “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act” is intended to update and replace the guidance issued in May 2016.

Scope & Applicability

Product Classes

2

Class II Device

Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders

Class III Device

Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.

Stakeholders

4

manufacturer

Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.

Designated person

Individual whose experience and qualifications must be provided.

IRB

Institutional Review Board providing study approvals

Medical Devices Dispute Resolution Panel

Panel that reviews disputes regarding medical device surveillance

Regulatory Context

Attributes

7

Plan Overdue

Status on FDA website if review is not completed within 60 days due to deficiencies

subject follow-up rate

Element required in the Final Postmarket Surveillance Report.

indications for use statement

FDA may request updates to this statement based on surveillance results.; Required description of the device's intended use.

Enrollment milestones

Target dates and numbers for subject recruitment

life-sustaining

Device characteristic triggering section 522 authority

life-supporting

Device characteristic triggering section 522 authority

Sample Size

statistically justified calculation required in the plan

Identified Hazards

Hazards

1

serious adverse health consequence

Criterion for requiring postmarket surveillance if device fails

Related CFR Sections (9)

21CFR822.28§ 822.28 If I stop marketing the device subject to postmarket surveillance, what must I do?
You must continue to conduct postmarket surveillance in accordance with your approved plan even if you no longer market the device. You may request that we allow you to terminate postmarket surveillance or modify your postmarket surveillance because you no longer market the device. We will make thesRead full regulation →
21CFR822.30§ 822.30 May I request exemption from the requirement to conduct postmarket surveillance?
You may request exemption from the requirement to conduct postmarket surveillance for your device or any specific model of that device at any time. You must comply with the requirements of this part unless and until we grant an exemption for your device. Your request for exemption must explain why yRead full regulation →
21CFR822.3§ 822.3 How do you define the terms used in this part?
Some of the terms we use in this part are specific to postmarket surveillance and reflect the language used in the statute (law). Other terms are more general and reflect our interpretation of the law. This section of the part defines the following terms:Read full regulation →
21CFR822.9§ 822.9 What must I include in my submission?
Your submission must include the following:Read full regulation →
21CFR822.10§ 822.10 What must I include in my surveillance plan?
Your surveillance plan must include a discussion of:Read full regulation →
21CFR822.20§ 822.20 What are the consequences if I fail to submit a postmarket surveillance plan, my plan is disapproved and I fail to submit a new plan, or I fail to conduct surveillance in accordance with my approved plan?
The failure to have an approved postmarket surveillance plan or failure to conduct postmarket surveillance in accordance with the approved plan constitutes failure to comply with section 522 of the act. Your failure would be a prohibited act under section 301(q)(1)(C) of the act, and your device wouRead full regulation →
21CFR822.22§ 822.22 What recourse do I have if I do not agree with your decision?
(a) If you disagree with us about the content of your plan or if we disapprove your plan, or if you believe there is a less burdensome approach that will answer the surveillance question, you may request review of our decision by:Read full regulation →
21CFR10.75§ 10.75 Internal agency review of decisions.
(a) A decision of an FDA employee, other than the Commissioner, on a matter, is subject to review by the employee's supervisor under the following circumstances:Read full regulation →
21CFR822.38§ 822.38 What reports must I submit to you?
You must submit interim and final reports as specified in your approved postmarket surveillance plan. In addition, we may ask you to submit additional information when we believe that the information is necessary for the protection of the public health and implementation of the act. We will also staRead full regulation →