Hi friends!!!

In our previous blogs, we have discussed about the following topics.

In today’s blog, we will explore about Premarket Approval & its requirements. Whether you’re a startup or established manufacturer, understanding the Premarket Approval is vital for ensuring regulatory compliance and bringing your product to the market

It is also important for Medical Device QA/RA Professionals to know in detail about Premarket Approval.

Let’s get into the topic.

Premarket Approval (PMA)

High risk category medical devices (Class III) are subjected to Premarket Approval requirements.

Medical Devices which possess following functions can be considered as high-risk category medical devices but are not limited to the following:

Support or sustain human life, substantial importance in preventing impairment of human health, potential for unreasonable risk of illness or injury

Also, medical devices which cannot assure safety and effectiveness solely based on general and special controls shall be subjected to PMA requirements.

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Contents of Premarket Approval

Name and address of applicant

Table of contents

Indications for use

Description of device and functional components or ingredients

Reference to performance standards

Environmental assessment

Manufacturing (methods, facilities and controls used in manufacturing process)

Bibliography of published reports

Sample of device, if practical

Proposed labeling

Financial certification or disclosure

Information concerning uses in pediatric patients

Pre-clinical studies: Test reports, summaries and conclusions of all pre-clinical studies shall be submitted. (The pre-clinical studies shall include but not limited to Bench and animal testing, Biocompatibility, Software, Engineering, Electromagnetic Compatibility (EMC), Electromagnetic Interference (EMI))

Clinical studies: Any information related to clinical studies conducted within and outside United States which supports safety and effectiveness, benefit-risk determination shall be submitted. The clinical study data shall include all methods, results, conclusions that are reasonably obtainable by the submitter which can be either adverse or supportive

Post Approval Controls

PMA regulatory controls for post approval includes the following:

Post approval studies and reports:

To ensure continued safety and effectiveness of the device (Eg: Long time performance data). The Post Approval Study reports need to be submitted as prescribed by FDA at a regular interval to ensure compliance.

Supplements:

Changes which affects the safety and effectiveness of PMA approved devices shall be informed to FDA in the form of Post Approval Supplement prior to implementing the change.

Amendments:

Changes which are time sensitive and do not affect the safety and effectiveness of PMA approved medical device shall be reported to FDA in the form of Post Approval Amendment. (Eg: Change in contact information, etc.,)

30-day notice of manufacturing changes.

Post approval periodical reporting (Annual Reports):

The PMA Annual reports shall be submitted to FDA annually. The PMA annual reports shall include the following information but are not limited to:

Information about the changes submitted as supplements along with any other changes which are not submitted previously.

Information about the sales of the device.

The summary and bibliography of published and unpublished reports.

PMA Review Process

The PMA review process will take approximately 180 days and is a four-step review process, it includes the following:

Acceptance and filling review:

The FDA checks the completeness of the PMA application against to pre-determined checklist. It checks the adequacy of the application to proceed with further in-depth reviews. If the PMA application is adequate, within 45 days from receiving the application, the FDA will notify the applicant with the information about the filling of PMA application in a letter along with PMA reference number and the date when FDA filled the application. The 180 days review process starts from the date of filling the application.

Substantive review:

In Substantive review, the in-depth review of the PMA application happens. The FDA may notify the applicant of any deficiencies or information needed via a letter. The applicant shall discuss the review status of the application with the FDA by submitting a request to meet with FDA within 100 days of filling the PMA application.

Panel review:

The FDA may prefer outside panel of experts to review the PMA application. Generally, FDA may go for external review for first of its kind device PMA applications

FDA Final decision

The FDA shall issue the final notification to the applicant to approve or reject the PMA application.

Now I hope you have acquired some basic knowledge about the requirements of US FDA Premarket Approval. We will meet again with another valuable topic related to MedTech Quality & Regulatory, Biomedical Engineering, Medical Device, Healthcare.

NOTE: Dear friends!!!… Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

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