CPG Sec. 390.425 Records and Reports; Applicability - 21 CFR 1002.1

Description

Because of cooperative or contractual arrangements between certain manufacturers and/or distributors of an electronic product, it is not clear who is required to submit the required reports for the product pursuant to *21 CFR 1002.1.* For example ABC Corporation designed a laser product, tested prototypes, contracted the manufacture of the product to XYZ Corporation, and supplied some but not all of the components for manufacture to XYZ. XYZ then shipped all finished units to ABC which in turn only distributes through another company. Which company is responsible for maintaining records and filing reports?

Scope & Applicability

• 21CFR890.1925§ 890.1925 Isokinetic testing and evaluation system.

  (a) Identification. An isokinetic testing and evaluation system is a rehabilitative exercise device intended for medical purposes, such as to measure, evaluate, and increase the strength of muscles and the range of motion of joints.Read full regulation →

• 21CFR890.5360§ 890.5360 Measuring exercise equipment.

  (a) Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide Read full regulation →

• 21CFR890.5380§ 890.5380 Powered exercise equipment.

  (a) Identification. Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include a powered treadmill, a powered bicycle, and powered parallel bars.Read full regulation →

• 21CFR890.5410§ 890.5410 Powered finger exerciser.

  (a) Identification. A powered finger exerciser is a device intended for medical purposes to increase flexion and the extension range of motion of the joints of the second to the fifth fingers of the hand.Read full regulation →

• 21CFR807.95§ 807.95 Confidentiality of information.

  (a) The Food and Drug Administration will disclose publicly whether there exists a premarket notification submission under this part:Read full regulation →

• 21CFR807.90§ 807.90 Format of a premarket notification submission.

  Each premarket notification submission pursuant to this part shall be submitted in accordance with this section. Each submission shall:Read full regulation →

• 21CFR801.109§ 801.109 Prescription devices.

  A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →

• 21CFR807.92§ 807.92 Content and format of a 510(k) summary.

  (a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. All 510(k) summaries shall conRead full regulation →

• 21CFR807.93§ 807.93 Content and format of a 510(k) statement.

  (a)Read full regulation →

• 21CFR807.87§ 807.87 Information required in a premarket notification submission.

  Each premarket notification submission shall contain the following information:Read full regulation →

• 21CFR890.5350§ 890.5350 Exercise component.

  (a) Identification. An exercise component is a device that is used in conjunction with other forms of exercise and that is intended for medical purposes, such as to redevelope muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include weights, dumbbells, strRead full regulation →

• 21CFR890.5370§ 890.5370 Nonmeasuring exercise equipment.

  (a) Identification. Nonmeasuring exercise equipment consist of devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include a prone scooter board, parallel bars, a mechanical treadmill, an exercise taRead full regulation →

• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device

  SeniorLife Technologies, Inc.

  2025-09-16

• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device

  Exer Labs, Inc.

  2025-03-25

• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device, Misbranded

  Trexo Robotics Holdings Inc.

  2024-06-04

• Medical Devices/Adulterated/Quality System Regulation (QSR)

  iRhythm Technologies, Inc.

  2023-06-06

• Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)

  Tenderneeds Fertility LLC

  2020-04-21

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