21 U.S.C. § 360oo — Prohibited acts
submitted 88 years ago by Pub. L. 90-602 to r/title-21-FOOD-AND-DRUGS · 304 words · no verdicts yet
This law bans selling or importing electronics that violate federal radiation safety standards. It's also illegal to skip required safety reports, ignore recordkeeping rules, or issue a false certification. The FDA can grant exemptions for research, testing, or national security.
(a) It's unlawful to:
(1) as a manufacturer*, sell, deliver for sale, or import into the U.S. any electronic product* that doesn't meet an applicable radiation-safety standard;
(2) fail to give any required notification or information under section 360ll or 360nn, or fail to follow the repair/replace/refund duties in section 360ll(f);
(3) fail or refuse to keep the records this part requires, or refuse to let the FDA inspect or copy those records, or refuse to allow entry or inspection under section 360nn;
(4) fail or refuse to file a required report under section 360nn(b), or fail to provide or keep required information under section 360nn(f); or
(5)(A) fail to issue a certification required under section 360kk(h), or (B) issue that certification without a proper test or testing program behind it, or issue it when the issuer, acting carefully, should have known it was false or misleading in an important way.
(b) The FDA can exempt any electronic product, or category of products, from all or part of subsection (a), on whatever conditions it thinks necessary to protect public health or welfare — for purposes like research, investigation, study, demonstration, training, or national security.
It shall be unlawful—
for any manufacturer* to introduce, or to deliver for introduction, into commerce*, or to import into the United States, any electronic product* which does not comply with an applicable standard prescribed pursuant to section 360kk of this title;
for any person* to fail to furnish any notification or other material or information required by section 360ll or 360nn of this title; or to fail to comply with the requirements of section 360ll(f) of this title;
for any person to fail or to refuse to establish or maintain records required by this part or to permit access by the Secretary* or any of his duly authorized representatives to, or the copying of, such records, or to permit entry or inspection, as required by or pursuant to section 360nn of this title;
for any person to fail or to refuse to make any report required pursuant to section 360nn(b) of this title or to furnish or preserve any information required pursuant to section 360nn(f) of this title; or
for any person (A) to fail to issue a certification as required by section 360kk(h) of this title, or (B) to issue such a certification when such certification is not based upon a test or testing program meeting the requirements of section 360kk(h) of this title or when the issuer, in the exercise of due care, would have reason to know that such certification is false or misleading in a material respect.
The Secretary may exempt any electronic product, or class thereof, from all or part of subsection (a), upon such conditions as he may find necessary to protect the public health or welfare, for the purpose of research, investigations, studies, demonstrations, or training, or for reasons of national security.
Source credit: (June 25, 1938, ch. 675, § 538, formerly act July 1, 1944, ch. 373, title III, § 538, formerly § 360B, as added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat. 1184; renumbered § 538 and amended Pub. L. 101–629, § 19(a)(1)(B), (2)(F), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, § 4(a)(2), Aug. 13, 1993, 107 Stat. 779.)
- 1938Enacted · Pub. L. 90-602 · 82 Stat. 1184
- 1990Amended · Pub. L. 101-629 · 104 Stat. 4529, 4530
- 1993Amended · Pub. L. 103-80 · 107 Stat. 779
A history note hasn’t been published yet. The record shows enactment by Pub. L. 90-602 on 1938-06-25.
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