Post Market surveillance requirements are set out in Title 21 Code of Federal Regulation (CFR) Part 822. This section aims to put an adequate post-market surveillance authority into practice to increase the possibility that post-market surveillance (PMS) plans will result in valuable data gathering. These data can show unanticipated adverse events, the actual frequency of anticipated adverse events, or other details important for public health protection.
FDA will assign a post-market surveillance (PS) order number (i.e., PS######) to each post-market surveillance order. Manufacturers should cite the assigned PS order number when submitting a proposed post-market surveillance plan. PMS plans are reviewed under the assigned PS order number. If the same PS order has multiple questions, manufacturers must provide a separate plan explaining the methodologies to address each question. The submission of the PMS plan must be made within 30 days of receipt of the 522 Order.
The FDA will review and respond within 60 days of receiving the plans. FDA intends to review post-market surveillance plans immediately and collaborate with the manufacturer to decide within 30 days of receiving the plan. To ensure that a full review of the surveillance plan can be completed within 60 calendar days of the 522-order date, the manufacturer should give any deficiencies in the plan identified by the agency top priority and collaborate actively with the FDA.
Sections of a PMS plan
The following sections must be included in a PMS plan. These sections are outlined in 21 CFR 822.10.
- PMS plan objectives addressing surveillance questions
- The surveillance approach, i.e., the design or methodology used
- Variables and endpoints used to answer the surveillance questions
- Subject of study
- Sample size
- Description of data source and its relevance
- Description of the data collection plan
- Data collection forms, informed consent forms and Institutional Review Board
(IRB) approval or IRB exemption documentation, where applicable
- Patient follow-up plan or schedule
- All data analysis and statistical tests planned
- Investigators agreement
- procedures for monitoring the conduct and progress of the surveillance,28 and estimate of the duration of the surveillance
- content and timing of PMS reports
In addition to the above, FDA also recommends the following:
- an interim data release plan which includes the frequency of interim analyses, type of analysis, data endpoints that will be assessed, content and frequency of posting on the FDA page for post-market surveillance
- background on the device, including device description, indications of use and regulatory history
Evaluation of PMS plan
To determine whether the proposed surveillance plan is complete, whether the person designated to conduct the surveillance has the necessary training and experience to carry out such surveillance, and whether the plan will result in the collection of valuable data that can reveal unforeseen adverse events or other information required to protect the public health, FDA will assess the proposed surveillance plan. This evaluation will help FDA determine the answer to the surveillance question (s).
Considering this, FDA may send one of the subsequent letters:
- Not acceptable letter
- Approval letter
- Major deficiency letter
- Disapproval letter
The not-acceptable letter is issued when the submission is incomplete and does not include the items in 822.9 and 822.10.
The approval letter demonstrates the FDA’s approval of the proposed surveillance plan in its submitted form and any requirements or suggestions the agency may have had for the plan.
Major Deficiency Letter identifies grave deficiencies in the plan’s ability to produce the data necessary to address the surveillance issues. Before the surveillance plan is approved, the manufacturer must fix these issues and respond to requests for specific information within the allotted timeframe.
The disapproval Letter demonstrates the FDA’s disapproval of the proposed plan because, in FDA’s opinion, it is unlikely to result in the gathering of relevant data necessary to address the post-market surveillance issues raised by the 522 order. The letter instructs the manufacturer to update its post-market surveillance plan by submitting a completely new submission within the allotted timeframe that suggests a new post-market surveillance plan meant to address the post-market surveillance concerns in the 522 order.
Changes to the Approved PMS plan
Manufacturers must get FDA clearance in writing before making changes to approved post-market surveillance plans if those changes would impact the nature or validity of the data gathered. These changes could be changes to sample size, endpoints and so on
It is not recommended for a manufacturer to combine their surveillance approach along with any 522 reports, but instead should include the request in a supplement to the PS order number (PS######) with the updated post-market surveillance plan for FDA review.
How is the review done for the PMS plan?
FDA reviews post-market surveillance plans and responds within 60 calendar days of receipt. FDA intends to promptly review post-market surveillance plans and work alongside manufacturers to issue a decision within 30 calendar days of receiving the plan. The checklist used by FDA to evaluate the PMS plan can be found in the guidance document for post-market surveillance.