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21 U.S.C. § 360nnInspection, records, and reports

submitted 88 years ago by Pub. L. 90-602 to r/title-21-FOOD-AND-DRUGS · 906 words · no verdicts yet

in plain englishAI-generated · not legal advice

The FDA can inspect factories that make electronics if it has good reason to suspect radiation-safety problems. Manufacturers must keep records, report data, and let inspectors review relevant documents. The FDA can share accident reports publicly but must protect trade secrets.

(a) Inspection of premises If the FDA has good cause to think a factory's radiation-safety testing methods or programs might be inadequate or unreliable, FDA officers can enter that factory (after showing credentials and written notice) at reasonable times, to look at the areas where the required tests are done and inspect the related facilities and procedures. Inspections must start and finish promptly. Good cause automatically exists if the manufacturer has already sold a noncompliant product without getting an exemption from the notification rules. (b) Record keeping Manufacturers must keep records (including testing records), file reports, and give the FDA information reasonably needed to check compliance with this part and its standards. On request, they must let FDA officers inspect the relevant books, papers, records, and documents. (c) Disclosure of technical data Manufacturers must give the FDA performance and other safety-related technical data as needed to carry out this law. The FDA can require manufacturers to pass some of that data on to the original buyer, after consulting the affected industry. (d) Public nature of reports Accident and investigation reports made by FDA staff or agents can be used as evidence in civil, criminal, or other legal proceedings related to that accident. FDA staff can be required to testify about what their investigations found. These reports must be made public in a way that doesn't identify individuals. Reports on research projects, demonstrations, and related activities are also public. (e) Trade secrets The FDA cannot disclose trade secrets or other protected information it gets under subsections (a) or (b), except to other government staff working on this law, or when relevant in an official proceeding — but the FDA cannot withhold information from properly authorized congressional committees. (f) Information required to identify and locate first purchasers of electronic products The FDA can require dealers and distributors of products (priced at $50 or more) to give manufacturers the information needed to identify and locate first buyers, for notification purposes under section 360ll. Manufacturers must preserve that information. Any regulation doing this must let dealers choose to hold the information themselves instead of immediately sending it, as long as they promptly tell the manufacturer they're holding it; they must then send it over when the manufacturer or FDA says it's needed. If a dealer stops selling that kind of product, it must turn the information over to the manufacturer. Manufacturers must keep this buyer information confidential and use it only to send required safety notices.
the actual law source: uscode.house.gov ↗public domain
(a) Inspection of premises

If the Secretary finds for good cause that the methods, tests, or programs related to electronic product radiation safety in a particular factory, warehouse, or establishment in which electronic products are manufactured or held, may not be adequate or reliable, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are thereafter authorized (1) to enter, at reasonable times, any area in such factory, warehouse, or establishment in which the manufacturer’s tests (or testing programs) required by section 360kk(h) of this title are carried out, and (2) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, the facilities and procedures within such area which are related to electronic product radiation safety. Each such inspection shall be commenced and completed with reasonable promptness. In addition to other grounds upon which good cause may be found for purposes of this subsection, good cause will be considered to exist in any case where the manufacturer has introduced into commerce any electronic product which does not comply with an applicable standard prescribed under this part and with respect to which no exemption from the notification requirements has been granted by the Secretary under section 360ll(a)(2) or 360ll(e) of this title.

(b) Record keeping

Every manufacturer of electronic products shall establish and maintain such records (including testing records), make such reports, and provide such information, as the Secretary may reasonably require to enable him to determine whether such manufacturer has acted or is acting in compliance with this part and standards prescribed pursuant to this part and shall, upon request of an officer or employee duly designated by the Secretary, permit such officer or employee to inspect appropriate books, papers, records, and documents relevant to determining whether such manufacturer has acted or is acting in compliance with standards prescribed pursuant to this part.

(c) Disclosure of technical data

Every manufacturer of electronic products shall provide to the Secretary such performance data and other technical data related to safety as may be required to carry out the purposes of this part. The Secretary is authorized to require the manufacturer to give such notification of such performance and technical data at the time of original purchase to the ultimate purchaser of the electronic product, as he determines necessary to carry out the purposes of this part after consulting with the affected industry.

(d) Public nature of reports

Accident and investigation reports made under this part by any officer, employee, or agent of the Secretary shall be available for use in any civil, criminal, or other judicial proceeding arising out of such accident. Any such officer, employee, or agent may be required to testify in such proceedings as to the facts developed in such investigations. Any such report shall be made available to the public in a manner which need not identify individuals. All reports on research projects, demonstration projects, and other related activities shall be public information.

(e) Trade secrets

The Secretary or his representative shall not disclose any information reported to or otherwise obtained by him, pursuant to subsection (a) or (b) of this section, which concerns any information which contains or relates to a trade secret or other matter referred to in section 1905 of title 18, except that such information may be disclosed to other officers or employees of the Department and of other agencies concerned with carrying out this part or when relevant in any proceeding under this part. Nothing in this section shall authorize the withholding of information by the Secretary, or by any officers or employees under his control, from the duly authorized committees of the Congress.

(f) Information required to identify and locate first purchasers of electronic products

The Secretary may by regulation (1) require dealers and distributors of electronic products, to which there are applicable standards prescribed under this part and the retail prices of which is not less than $50, to furnish manufacturers of such products such information as may be necessary to identify and locate, for purposes of section 360ll of this title, the first purchasers of such products for purposes other than resale, and (2) require manufacturers to preserve such information. Any regulation establishing a requirement pursuant to clause (1) of the preceding sentence shall (A) authorize such dealers and distributors to elect, in lieu of immediately furnishing such information to the manufacturer, to hold and preserve such information until advised by the manufacturer or Secretary that such information is needed by the manufacturer for purposes of section 360ll of this title, and (B) provide that the dealer or distributor shall, upon making such election, give prompt notice of such election (together with information identifying the notifier and the product) to the manufacturer and shall, when advised by the manufacturer or Secretary, of the need therefor for the purposes of section 360ll of this title, immediately furnish the manufacturer with the required information. If a dealer or distributor discontinues the dealing in or distribution of electronic products, he shall turn the information over to the manufacturer. Any manufacturer receiving information pursuant to this subsection concerning first purchasers of products for purposes other than resale shall treat it as confidential and may use it only if necessary for the purpose of notifying persons pursuant to section 360ll(a) of this title.

Source credit: (June 25, 1938, ch. 675, § 537, formerly act July 1, 1944, ch. 373, title III, § 537, formerly § 360A, as added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat. 1182; renumbered § 537 and amended Pub. L. 101–629, § 19(a)(1)(B), (2)(E), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, § 4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

history & why it existsrecord from the source credit
  • 1938Enacted · Pub. L. 90-602 · 82 Stat. 1182
  • 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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