What does PACR mean in UNCLASSIFIED
PACR (Post Authorization Change Report) is a regulatory document submitted to the relevant regulatory authority, usually a national or regional health authority, to notify them of a change to a marketed medical product or device after it has received marketing authorization. PACRs are required to ensure the continued safety and efficacy of the product and to comply with regulatory requirements.
PACR meaning in Unclassified in Miscellaneous
PACR mostly used in an acronym Unclassified in Category Miscellaneous that means Post Authorization Change Report
Shorthand: PACR,
Full Form: Post Authorization Change Report
For more information of "Post Authorization Change Report", see the section below.
PACR Requirements
PACRs are typically required for changes that could significantly impact the safety or performance of the product, such as:
- Changes to the product's formulation or manufacturing process
- New or updated clinical data indicating changes to the product's risk-benefit profile
- Changes to the product's labeling or instructions for use
- Changes to the product's distribution or marketing status
PACR Submission
The format and content of PACRs may vary depending on the regulatory authority, but generally include the following information:
- A detailed description of the change
- The rationale for the change
- An assessment of the potential impact of the change on the product's safety and efficacy
- Supporting data, such as clinical studies or risk assessments
- A proposed implementation plan
PACR Review and Approval
Regulatory authorities review PACRs to determine whether the proposed change is acceptable and does not pose an unacceptable risk to public health. The review process can involve independent assessments, consultation with experts, and discussions with the product manufacturer.
Essential Questions and Answers on Post Authorization Change Report in "MISCELLANEOUS»UNFILED"
What is a Post Authorization Change Report (PACR)?
A Post Authorization Change Report (PACR) is a document submitted to a regulatory authority to notify them of any changes made to a medical device after it has been authorized for marketing. PACRs are required to ensure that the device remains safe and effective after the changes have been made.
What information is included in a PACR?
A PACR typically includes information about the change, the reason for the change, and the potential impact of the change on the safety and effectiveness of the device. The specific information required will vary depending on the type of change and the regulatory authority to which the PACR is being submitted.
When is a PACR required?
A PACR is required whenever a change is made to a medical device that could affect its safety or effectiveness. This includes changes to the design, materials, manufacturing process, or intended use of the device.
Who is responsible for submitting a PACR?
The manufacturer of the medical device is responsible for submitting a PACR. The manufacturer must submit the PACR to the regulatory authority in the country where the device is being marketed.
What are the consequences of not submitting a PACR?
Failure to submit a PACR can result in regulatory action, including fines or the withdrawal of the device from the market.
Final Words: PACRs are an essential part of the post-market surveillance system for medical products and devices. They ensure that changes to marketed products are closely monitored and evaluated to protect the safety and well-being of patients. Compliance with PACR requirements is crucial for manufacturers to maintain market authorization and demonstrate their commitment to the safety and efficacy of their products.
PACR also stands for: |
|
| All stands for PACR |