Special Controls Medical Devices

Class II Special Controls Documents | FDA

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/class-ii-special-controls-documents

Devices classified into class II are devices for which special controls, combined with ...

Regulatory Controls | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/overview-device-regulation/regulatory-controls

Classify Your Medical Device | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

The three classes and the requirements which apply to them are: Device Class and Regulatory Controls 1. Class I General Controls With Exemptions Without Exemptions …

General Controls for Medical Devices | FDA

https://www.fda.gov/medical-devices/regulatory-controls/general-controls-medical-devices

General Controls are the basic provisions (authorities) of the May 28, 1976 Medical Device Amendments (hereafter referred to as the Amendments) to the Food, Drug and Cosmetic …

De Novo Classification Request | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request

The De Novo request provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide …

Status of a Special Controls Guidance Document

https://medicaldeviceacademy.com/special-controls-guidance-document/

There are many differences between Class 1 and Class 2 medical devices regulated by the FDA, but one of the primary differences is that many (not all) Class 2 medical devices have a special controls …

Class II Special Controls Guidance Document: …

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/class-ii-special-controls-guidance-document-transcutaneous-air-conduction-hearing-aid-system-tachas

This guidance document was developed as a special controls guidance to support the classification of the Transcutaneous Air Conduction Hearing Aid System …

Class II Special Controls Guidance: Pharmacy …

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/pharmacy-compounding-systems-final-class-ii-special-controls-guidance-document-industry-and-fda

FDA identifies a PCD as an apparatus, often controlled by software, that is intended to deliver a specified quantity of one or more injections through a designated fluid pathway …

Instrumentation for Clinical Multiplex Test Systems

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/instrumentation-clinical-multiplex-test-systems-class-ii-special-controls-guidance-industry-and-fda

FDA believes that special controls, when combined with the general controls, provide reasonable assurance of the safety and effectiveness of instrumentation for clinical …

Medical Devices; Hematology and Pathology Devices; …

https://www.federalregister.gov/documents/2023/02/02/2023-02141/medical-devices-hematology-and-pathology-devices-classification-of-the-software-algorithm-device-to

The special controls for this device are: (1) The intended use on the device's label and labeling required under § 809.10 of this chapter must include: (i) …