Tap any paragraph to write a margin note. Your notes collect in the Desk below the text and file under cases with @. The side-by-side margin rail opens on a larger screen.

§
Marginalia
Code · CFR · Title 21 — Food and Drugs · Part 810 — Medical Device Recall Authority · § 810.16

§ 810.16. Cease distribution and notification or mandatory recall order status reports.

256 words·~1 min read·/us/cfr/t21/s§ 810.16·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(a)The person named in a cease distribution and notification order issued under § 810.10 or a mandatory recall order issued under § 810.13 shall submit periodic status reports to FDA to enable the agency to assess the person's progress in complying with the order. The frequency of such reports and the agency official to whom such reports shall be submitted will be specified in the order.
(b)Unless otherwise specified in the order, each status report shall contain the following information:
(1)The number and type of health professionals, device user facilities, consignees, or individuals notified about the order and the date and method of notification;
(2)The number and type of health professionals, device user facilities, consignees, or individuals who have responded to the communication and the quantity of the device on hand at these locations at the time they received the communication;
(3)The number and type of health professionals, device user facilities, consignees, or individuals who have not responded to the communication;
(4)The number of devices returned or corrected by each health professional, device user facility, consignee, or individual contacted, and the quantity of products accounted for;
(5)The number and results of effectiveness checks that have been made; and
(6)Estimated timeframes for completion of the requirements of the cease distribution and notification order or mandatory recall order.
(c)The person named in the cease distribution and notification order or recall order may discontinue the submission of status reports when the agency terminates the order in accordance with § 810.17.
Connections2 cite this
Cited by 2 sections
Citation graph
cites case law
§ 810.16
Cease distribution and notification or mandatory recall order status reports.
Fed. Reg.×2
Cites 0Cited by 2 across 1 source
★   the supreme law of the land   ★
Don't Tread on Me
E Pluribus Unum — out of many, one

"If you don't know your rights, you don't have any."

Marginalia · a citizen's law index
A research desk, not legal advice. Always read the cited source before relying on a summary.
Questions or an issue? support@self-law.org
disclaimerMarginalia is a research index, not a law firm. Nothing on this site is legal, tax, or financial advice and no attorney–client relationship is formed by using it. Statutes, regulations, and case law change; summaries, search results, AI output, and member posts may be incomplete, out of date, or wrong. Any interpretation drawn from material on this site should be validated by a licensed attorney in your jurisdiction before you act on it.