21 CFR 807.22 Registration and Listing Timeline

1. Key takeaways

21 CFR 807.22 sets out three binding deadlines for establishment registration and device listing in the United States. Initial registration and listing must be completed within 30 days after an establishment begins the activity described in 21 CFR 807.20(a). Annual registration and the annual listing update must be completed between October 1 and December 31 of each fiscal year, every year. Changes to registration information must be updated within 30 days after the change occurs. When any of these deadlines is missed, the establishment enters the ‘failed to register’ or ‘failed to list’ status, which is the compliance foundation behind most registration-related import problems in the United States market.

• Initial registration and listing: within 30 days of entering the covered activity, under 21 CFR 807.22(a).
• Annual registration: the window runs from October 1 to December 31, under 21 CFR 807.22(b)(1).
• Annual listing update: the same October 1 to December 31 window applies, and confirmation is required regardless of whether any listing information has changed, under 21 CFR 807.22(b)(3).
• Changes to registration information: within 30 days of the change, under 21 CFR 807.22(b)(2).
• A missed deadline triggers the ‘failed to register’ or ‘failed to list’ status, under 21 CFR 807.22(c).

2. Legal basis

The deadlines summarized above are not policy guidance; they are codified requirements with a specific regulatory history. The table below traces each deadline to its governing provision, the Federal Register document in which the current text was adopted, and the source where the provision can be verified.

3. Expert insights

Insight 1: The annual update is a confirmation obligation and is not waived simply because nothing has changed.

Under 21 CFR 807.22(b)(3), during the October 1 to December 31 window of each fiscal year, the owner or operator of an establishment must review and update all listing information. The regulation states that the accuracy of all information on file must be confirmed annually, whether or not the list of devices has changed. This is an explicit statutory formulation of the principle that even an unchanged listing must still be confirmed. In practical terms, a company whose product portfolio has been stable for years cannot treat the annual window as a formality to skip. The obligation is to perform an affirmative review and confirmation, and companies should be able to demonstrate that this confirmation action actually took place during the window.

Insight 2: The three deadlines start counting from three different points.

The 30-day clock for initial registration starts when the establishment begins the activity described in 21 CFR 807.20(a). The 30-day clock for updating registration information starts when the information changes. The annual update window, by contrast, is a fixed calendar interval that applies to every establishment at the same time of year. The three clocks cannot substitute for one another. Even if a company completed its initial registration in January of the same fiscal year, it is still required to complete the annual update between October 1 and December 31 of that year. Planning that treats initial registration as satisfying the annual obligation will leave the establishment exposed to a compliance lapse.

Insight 3: The consequence of missing a deadline is a lapse in status, not a fine.

Under 21 CFR 807.22(c), failure to submit the required information on time places the establishment in the ‘failed to register’ or ‘failed to list’ status. In that status, the establishment will not be considered active, and its registration and listing information may not appear on the FDA website. This condition persists until the establishment submits the required information and FDA has processed it. For foreign manufacturers, the practical significance is considerable: registration data on the FDA website is part of what is checked when shipments arrive at the port, so a lapsed status can translate directly into cargo being held at entry rather than into a monetary penalty notice.

Insight 4: FDA separately requires electronic submission and provides an exemption procedure.

Under 21 CFR 807.21 and 807.34, registration and listing information must be submitted through FDA’s electronic device registration and listing system. Establishments that have obtained an exemption submit by mail to the Import and Registration and Listing Team (IRLT) within CDRH. Electronic submission is therefore the normal operating channel, and the mailed route is the exception. Companies should organize their processes around the electronic system and treat any request for exemption as an exceptional step that requires justification.

4. Practical recommendations

The following measures translate the three deadlines in 21 CFR 807.22 into an operating routine that keeps an establishment outside the ‘failed to register’ and ‘failed to list’ statuses.

• Set three calendar reminders: a 30-day countdown for initial registration after entering the covered activity, an October 1 start date for the annual update, and a December 31 completion milestone.
• When registration information changes, such as the establishment name, address, or official correspondent, process it through the 30-day update route rather than waiting for the annual window.
• During the annual update period, treat the confirmation of information accuracy as a discrete action and keep a record of the confirmation even when nothing has changed.
• After completing any update, verify on the FDA website that the establishment’s status has returned to active.
• Treat electronic submission as the standard channel; applying for an exemption requires demonstrating that using the internet is not reasonable, which makes it an exceptional circumstance.

5. Verification checklist

Use the following items to confirm that an establishment’s registration and listing timeline obligations are fully under control.

• □ Initial registration was completed within 30 days of entering the covered activity.
• □ A calendar covering the October 1 to December 31 annual update window is in place.
• □ The annual update included an affirmative confirmation of accuracy, regardless of whether anything changed.
• □ A 30-day update process for changes to registration information has been established.
• □ After updates, the establishment’s status has been verified as active on the FDA website.
• □ The electronic submission channel is available; if an exemption is needed, it has been prepared in accordance with 21 CFR 807.34.

Regulatory information verified as of October 28, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, US Agent and local testing support for the United States market. Our team manages FDA establishment registration and listing, 510(k)/De Novo/PMA submissions, and supports post-market reporting obligations. Business enquiries: info@grzanglobal.com