Saturday, May 24, 2025

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.

Check out for this blog about Computed Tomography, X ray, MRI scan, ECG.

Generations of CT Scanners

COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS

x ray machine working principle

components of x ray tube

MRI scan

MRI With Contrast

Brain MRI

Types of MRI scanners

ELECTROCARDIOGRAM

12 Lead ECG Placement

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Check out for the below blogs about IEC 62304 & IEC 60601-1.

IEC 62304 Software Configuration Management & Problem Resolution Process

IEC 62304 Software Maintenance Process

IEC 62304 Software System Testing

IEC 62304 Software Unit Implementation & Integration

IEC 62304 Software Architectural & Detailed Design

IEC 62304 Software Requirements Analysis

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IEC 62304 Overview & Definitions

IEC 60601-1 Definitions

IEC 60601-1 Classification of Medical Electrical Equipment

IEC 60601-1 General Requirements for Testing Medical Electrical Equipment

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Saturday, March 29, 2025

US FDA De Novo Submission

Hi friends!!!

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

US FDA Premarket Notification 510(k)

EU MDR Assessment Routes

EU MDR Timeline, Annex, Chapter

EU MDR Post Market Surveillance

EU MDR Clinical Evaluation

EU MDR Technical Documentation - Part 1

EU MDR Technical Documentation - Part 2

EU MDR General Safety and Performance Requirement

EU MDR Information on the Label

EU MDR Post Market Clinical Follow Up

EU MDR Unique Device Identification - Part 1

EU MDR Unique Device Identification - Part 2

EU MDR Classification Rules

EU MDR EUDAMED

EU MDR Economic Operators

EU MDR Chapter & Articles - Part 1

EU MDR Chapter & Articles - Part 2

EU MDR Clinical Investigation

EU MDR Scrutiny Procedure

EU MDR Instructions for Use

EU MDR Procedure for Custom-Made Devices

EU MDR Certificates Issued by Notified Body

In today's blog, we will explore about De Novo submission & its requirements. Whether you're a startup or established manufacturer, understanding the De Novo submission 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 De Novo submission.

Let's get into the topic.

What is De Novo Request?

The De Novo request is a type of marketing pathway for classifying novel medical devices having general controls alone, or general and special controls (Low to Moderate risk devices) which provides a reasonable assurance of safety and effectiveness for the intended use, but there is not legally marketed predicate device for these kinds of novel medical devices.

The De Novo is also Intended for devices that are automatically classified into class III by virtue of not yet being classified. These devices shall satisfy the below classification process to get classified as Class I or Class II under De Novo request.

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What is the Classification Process?

The De Novo classification is a risk-based classification approach:

Determine if the probable benefit of using your device outweighs the probable risks associated.

Probable risks to health by using the device or product shall be determined.

Level of regulatory controls needed for the device shall be determined.

Once all the above mentioned are determined, the following condition shall be considered:

If only general controls are used for mitigating the risk, then the device is Class I.

If general controls + special controls are used for mitigating the risk, then the device is Class II.

When to submit for a De Novo Request?

Scenario 1: If your medical device receives a not substantially equivalent (NSE) result during a 510(k) submission (It means, your medical device does not have any predicate device, it has new intended use or different technological characteristics which raises a different question related to safety and effectiveness).

Scenario II: The Submitter or requester can determine that there is no legally marketed medical device upon which a substantial equivalence can be proved. (Before even submitting the 510(k) and receiving high level NSE).

What does the regulation say?

In general, 21 CFR 860 provides the bases for Medical Device Classification procedures. The 21 CFR 860 Subpart D states the requirement for De Novo submission. The following are the requirements:

860.200: Purpose and applicability.

860.210: De Novo request format.

860.220: De Novo request content.

860.230: Accepting a De Novo request.

860.240: Procedures for review of a De Novo request.

860.250: Withdrawal of a De Novo request.

860.260: Granting or declining a De Novo request.

Contents of De Novo request:

The following are the important information specific to De Novo request that needs to be submitted, but are not limited to:

Administrative Information (Eg: Applicant name, contact name, address & contact information)

Regulatory History (Previously submitted 510k and NSE decisions, IDE’s, pre-submission information, previously granted or declined De Novo details)

Device information and summary (Device name and description, intended use, indications for use, technological characteristics)

Classification summary

Summary of risks and mitigations

Summary of known/potential risk to health

Proposed special controls

Classification recommendation

Summary of studies (Eg: Pre-clinical, animal, clinical)

Benefit and risk considerations

Device labelling

Other information reasonably known to the requester

Other information to support reasonable assurance of safety and effectiveness

What happens if De Novo is granted?

Once De Novo is granted, the FDA establishes a new device type along with the classification regulation for the device, necessary controls and product code.

The De Novo granted device shall be considered as a first predicate device for its kind.

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