FDA Provides Guidance on 522 Postmarket Surveillance

In a move aimed at ensuring the safety and effectiveness of marketed products, the FDA has updated its thinking on 522 postmarket surveillance studies for Class II and III devices.

The guidance — issued May 16 — provides an overview of Section 522 of the FD&C and is intended to help medical device manufacturers fulfill related obligations. It also offers tips on the format, content and review of postmarket surveillance plans.

Section 522 gives the FDA the authority to require postmarket surveillance of devices that meet the following criteria:

• Their failure likely would cause serious adverse health consequences;
• They would see significant use in pediatric populations;
• They are intended to be implanted in the body for more than one year; or
• They are intended to be a life-sustaining or life-supporting device used outside a device user facility.

New Sections Added

Changes from the draft version — which was issued Aug. 11, 2011 — include a new section on the timing for issuing a 522 order and the start of postmarket surveillance.

The section informs manufacturers that the agency may issue a postmarket surveillance order at the time of device approval or clearance “or any time thereafter.” The manufacturer thus is required to begin postmarket surveillance no later than 15 months after the day the order is issued. That gives manufacturers three more months than what was provided for in the draft version.

Another change is the rewording of situations that could trigger a postmarket review.

The new document says the agency could order surveillance “to obtain more information on device performance associated with real-world clinical practice.” That marks a dramatic change from the draft version, which said the agency could order postmarket surveillance “to obtain more experience with a change from hospital use to use in the home or other environment.”

The guidance also adds color to the discussion of the process used to determine whether a problem potentially linked to a medical device warrants postmarket surveillance. The issue is reviewed by a pre-522 team, consisting of epidemiologists, clinicians or other experts, with an eye toward providing a recommendation on whether a 522 order should be issued.

The final document expands one of the elements the inspection team might review, providing examples of the potential data sources that could trigger a public health question that needs to be addressed. Examples include scientific concerns resulting from a review of a premarket submission, a recall and medical device reports.

In addition, the document greatly expands the section on changing an approved postmarket surveillance plan.

While the draft version included only two sentences on this topic the final document offers four paragraphs. For example, it explains that the FDA only will accept submissions that are “substantially complete,” adding that a not acceptable letter could be issued to those that fail to meet this standard.

“Unless FDA approves the revised surveillance plan, the manufacturer remains responsible for completing the approved surveillance plan. Failure to meet the milestones and timelines outlined in the approved surveillance plan may result in enforcement action by FDA,” the document warns.

Finally, the document also includes an appendix that lays out a Section 522 administrative checklist review.

Read the document here: www.fdanews.com/05-16-16-postmarket.pdf.