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21 CFR 26.69 - Monitoring of conformity assessment bodies.

§ 26.69
Monitoring of conformity assessment bodies.
The following shall apply with regard to the monitoring of conformity assessment bodies (CAB's) listed in subpart B of this part:
(a) Designating authorities shall assure that their CAB's listed in subpart B of this part are capable and remain capable of properly assessing conformity of products or processes, as applicable, and as covered in subpart B of this part. In this regard, designating authorities shall maintain, or cause to maintain, ongoing surveillance over their CAB's by means of regular audit or assessment;
(b) The parties undertake to compare methods used to verify that the CAB's listed in subpart B of this part comply with the relevant requirements of subpart B of this part. Existing systems for the evaluation of CAB's may be used as part of such comparison procedures;
(c) Designating authorities shall consult as necessary with their counterparts, to ensure the maintenance of confidence in conformity assessment procedures. With the consent of both parties, this consultation may include joint participation in audits/inspections related to conformity assessment activities or other assessments of CAB's listed in subpart B of this part; and
(d) Designating authorities shall consult, as necessary, with the relevant regulatory authorities of the other party to ensure that all technical requirements are identified and are satisfactorily addressed.

Title 21 published on 2012-04-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
USC : Title 5 - GOVERNMENT ORGANIZATION AND EMPLOYEES

§ 552 - Public information; agency rules, opinions, orders, records, and proceedings

USC : Title 15 - COMMERCE AND TRADE

§ 1453 - Requirements of labeling; placement, form, and contents of statement of quantity; supplemental statement of quantity

§ 1454 - Rules and regulations

§ 1455 - Procedure for promulgation of regulations

USC : Title 18 - CRIMES AND CRIMINAL PROCEDURE

§ 1905 - Disclosure of confidential information generally

USC : Title 21 - FOOD AND DRUGS

§ 321 - Definitions; generally

§ 331 - Prohibited acts

§ 351 - Adulterated drugs and devices

§ 352 - Misbranded drugs and devices

§ 355 - New drugs

§ 360 - Registration of producers of drugs or devices

§ 360b - New animal drugs

§ 360c - Classification of devices intended for human use

§ 360d - Performance standards

§ 360e - Premarket approval

21 USC § 360e–1 - Pediatric uses of devices

§ 360f - Banned devices

§ 360g - Judicial review

§ 360h - Notification and other remedies

§ 360i - Records and reports on devices

§ 360j - General provisions respecting control of devices intended for human use

21 USC § -

§ 360m - Accredited persons

§ 371 - Regulations and hearings

§ 374 - Inspection

§ 381 - Imports and exports

§ 382 - Exports of certain unapproved products

§ 383 - Office of International Relations

§ 393 - Food and Drug Administration

U.S.C. : Title 42 - THE PUBLIC HEALTH AND WELFARE

§ 216 - Regulations

§ 241 - Research and investigations generally

42 USC § -

§ 262 - Regulation of biological products

§ 264 - Regulations to control communicable diseases

§ 265 - Suspension of entries and imports from designated places to prevent spread of communicable diseases