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 878 — General and Plastic Surgery Devices · § 878.4360

§ 878.4360. Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.

304 words·~1 min read·/us/cfr/t21/s§ 878.4360·

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

(a)Identification. A scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia is a prescription device intended to reduce the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used.
(b)Classification—Class II (special controls). The special controls for this device are:
(1)Non-clinical performance testing must demonstrate that the device meets all design specifications and performance requirements, and that the device performs as intended under anticipated conditions of use. This information must include testing to demonstrate accuracy of the temperature control mechanism.
(2)Performance testing must demonstrate the electromagnetic compatibility and electrical safety of the device.
(3)Software verification, validation, and hazard analysis must be performed.
(4)The patient contacting components of the device must be demonstrated to be biocompatible. Material names must be provided.
(5)Labeling must include the following:
(i)A statement describing the potential risk of developing scalp metastasis.
(ii)Information on the patient population and chemotherapeutic agents/regimen for which the device has been demonstrated to be effective.
(iii)A summary of the non-clinical and/or clinical testing pertinent to use of the device.
(iv)A summary of the device technical parameters, including temperature cooling range and duration of cooling.
(v)A summary of the device- and procedure-related adverse events pertinent to use of the device.
(vi)Information on how the device operates and the typical course of treatment.
(6)Patient labeling must be provided and must include:
(i)Relevant contraindications, warnings, precautions, and adverse effects/complications.
(ii)Information on how the device operates and the typical course of treatment.
(iii)Information on the patient population for which there is clinical evidence of effectiveness.
(iv)The potential risks and benefits associated with use of the device.
(v)Postoperative care instructions.
(vi)A statement describing the potential risk of developing scalp metastasis. [81 FR 7453, Feb. 12, 2016]
Connections1 cite this
Cited by 1 section
Citation graph
cites case law
§ 878.4360
Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.
Fed. Reg.×1
Cites 0Cited by 1 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.