CPG Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices | Guideline Explorer

Description

Document issued on October 3, 2006 and supersedes Compliance Policy Guide (CPG) “Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices (CPG 7150.16)” that was issued in March 1995.

Scope & Applicability

Product Classes

1

Medical Device

FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices

Stakeholders

1

Applicant

Entity submitting development data and knowledge; Entity performing the work process for change

Regulatory Context

Attributes

2

Safety and Effectiveness

Cybersecurity is part of device safety and effectiveness

Expedited PMA

PMA status that triggers shorter review timelines

Related CFR Sections (2)

21CFR814.39§ 814.39 PMA supplements.
(a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a type for which FDA, under paragraph (e) of thRead full regulation →
21CFR814.20§ 814.20 Application.
(a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identRead full regulation →

Related Warning Letters (10)

CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
2025-12-09
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Contec Medical Systems Co., Ltd.
2025-10-28
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LEVO AG
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CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
2025-10-07
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
2025-09-23
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
2025-09-16
CGMP/QSR/Medical Devices/Adulterated
Miach Orthopaedics
2025-08-26