Critical Insights into Postmarket Surveillance: Compliance with 21 CFR Part 822

When bringing a device to the market, it doesn't stop as soon as you get the initial approval. As a manufacturer you have to make sure that you collect information about your device when it's out there. Collecting this information allows you to resolve possible issues, improve the safety and performance and ensure that your device remains compliant. It comes as no surprise that regulators require this information as part of their efforts to monitor the market.

In the US, Post-Market Surveillance (PMS) is mainly used in the context of the US FDA which has the authority to require manufacturers to perform studies of Class II or III devices which have been granted 510(k) clearance or PMA approval. This is regulated in section 522 of the Federal Food, Drug and Cosmetic Act. 21 CFR Part 822 further implements section 522 and provides procedures and requirements for PMS.

What is 21 CFR Part 822

21 CFR Part 822 implements the requirements of section 522. This applies to class II and III devices which meet any of the following criteria:

(a) Failure of the device would be reasonably likely to have serious adverse health consequences

(b) The device is intended to be implanted in the human body for more than 1 year

(c) The device is intended to be used outside a user facility to support or sustain life. If you fail to comply with requirements that we order under section 522 of the Federal Food, Drug, and Cosmetic Act and this part, your device is considered misbranded under section 502(t)(3) of the Federal Food, Drug, and Cosmetic Act and you are in violation of section 301(q)(1)(C) of the Federal Food, Drug, and Cosmetic Act

(d) The device is expected to have significant use in pediatric populations.

The goal of this part of the legislation is to define expectations in terms of PMS plans and collected data. These data can reveal unforeseen adverse events, provide feedback on previous estimations related to adverse events and can as well provide other useful information to protect public health.

Who needs to be compliant with 21 CFR Part 822

When FDA requests Post-Market Surveillance from a manufacturer whose devices are within the scope described above, they need to comply with Part 822.

What are the different parts of 21 CFR Part 822 and their requirements?

21 CFR Part 822 has 7 subparts which further detail the requirements related to PMS planning, data to be collected and reporting.

Subpart A - General Provisions

This subpart provides the scope and definitions used in Part 822.

Subpart B - Notifications

In this subpart it is described how FDA requests for PMS reports and how to react to those requests

Subpart C - Post-Market Surveillance Plan

In this subpart it is described what is expected from a PMS plan. 

Subpart D - FDA Review and Action

After submitting the plan, FDA will review the provided documentation and can come back with a decision. The review takes up to 60 days. 

Subpart E - Responsibilities of the Manufacturer

This section describes that manufacturers need to conduct PMS activities as per their submitted plan. It also describes what to do in case of changes to the plan or the manufacturer.

Subpart F - Waivers and Exemptions

Waivers and exemptions can be requested. However, until they are granted, the requirements of Part 822 apply.

Subpart G - Records and Records

Records of communication and of PMS activities need to be kept. Interim reports and Final reports need to be submitted as defined in the approved PMS plan. Records need to be kept at least until 2 years after approval of the PMS plan.

How does 21 CFR Part 822 link to other parts of the CFR?

There are other parts of the US legislation for medical devices that also include parts of PMS activities and that are applicable to all classes of devices:

• The Medical Device Reporting (MDR) regulation contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA

• 21 CFR Part 7 contains requirements for conducting an effective recall.

• 21 CFR Part 806, Medical Device Corrections and Removals contains reporting requirements and maintenance of records for corrections and removals.

• 21 CFR 820.198 Complaint Files

PMS in Europe vs US

PMS is not only a requirement in the US. Also in Europe and in other regions of the world, there is a lot of attention to post-market surveillance. 

In the 2017/745 Medical Device Regulation, PMS requirements come back in several articles:

• Article 15 - Person responsible for regulatory requirements

• Article 83 - Post-market surveillance system for the manufacturer

• Article 84 - Post-market surveillance plan

• Article 85 - Post-market surveillance report

• Article 86 - Periodic safety update report

• Annex 3 - Technical documentation for post-market surveillance system

Furthermore are there also requirements for PMS is standards, which are harmonized/recognized in both areas. Clause 8 of ISO 13485:2016 describes the last step in the PDCA cycle where post-market data needs to be collected, analyzed and improvements needs to be defined accordingly. In clause 10 of ISO 14971:2019 the need for an active process for gaining information, as opposed to just waiting for complaints is emphasized, which is in line with the requirements of regulators.

Matrix Requirements for 21 CFR Part 822 compliance

Post-Market Surveillance activities are an integral part of the PDCA cycle which is embedded in your QMS and directly affect the design of your device. This means that the information you obtain from the field, needs to be analyzed and might lead to changes in your risk analysis and/or the requirements or specifications of your device. These changes need to be carefully documented and tested. Matrix Requirements provides a platform with both a module for product design, called MatrixALM and a module for your QMS, called MatrixQMS. As they are both on the same platform, it means that your QMS and Design information can be linked together. With a full traceability, it helps you to more efficiently manage changes in your design and extract all needed documentation without much effort. If you would like to see Matrix in action, don't hesitate to contact us.