Medical Device Exemptions 510(k) and GMP Requirements | 合法醫療器材資訊網

Followingisabreakdownof510(k)exemptandGoodManufacturingPractice(​GMP)/QualitySystemexemptionslistedbydeviceclass.Alldevicesinthislistare​ ...

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Introduction

Following is a breakdown of 510(k) exempt and Good Manufacturing Practice (GMP)/Quality System exemptions listed by device class. All devices in this list are 510(k) exempt unless further qualified by a footnote. Only devices annotated by (*) are also exempt from GMP except for general recordkeeping requirements and compliant files.

Class I Devices

FDA has exempted almost all class I devices (with the exception of Reserved Devices[1] from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. Some 510(k) exemptions annotated with "#" are with certain limitations as noted in the footnotes. It is important to confirm the exempt status and any limitations that apply with 21...