Online Safety Community

Tips and Suggestions on interacting with FDA Officials and Premarket Approval (PMA)

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k) clearance.

What makes preparing premarket submissions that win regulatory approval challenging? It is the fact, acknowledged by the FDA itself, that the PMA is the most stringent type of device marketing application required by the FDA. The PMA should be secured from the FDA before the company markets the medical device. The FDA gives its approval of the PMA for a Class II medical device only after it determines that all the elements necessary for assuring that the application has enough scientific confirmation that it is safe and effective for the intended uses it is going to be put to. Preparing premarket submissions thus is an onerous task by any stretch of imagination.

Another element of preparing premarket submissions that win regulatory approval

Another aspect of preparing premarket submissions is the 510 (k). The 510 (k) is essentially a kind of premarket submission that is made to the FDA to show that the device that a manufacturer intends to market is at least as effective and safe as a legally marketed device of its equivalence, already in the market, that is not subject to PMA. The FDA calls this principle the substantial equivalency (SE) and the device that is used as the reference for equivalence, the predicate device. The requirements governing SE are contained in 21 CFR 807.92(a) (3).

On top of all these, regulatory professionals have the responsibility of creating preparing premarket submissions that should not only convincingly demonstrate the ways of stating and explaining regulatory arguments for their device to the U.S. FDA reviewer for getting the approval; they should also be presentable and well-organized, without being cluttered or confusing.

Professional trainings for preparing premarket submissions that win regulatory approval

Given all these, it goes without saying that a completely thorough understanding and knowledge of the relevant U.S. FDA laws, regulations and requirements is absolutely necessary for regulatory professionals. This in-depth understanding can be had only from thorough training, which is indispensable if the medical device company is to win a clearance or approval.

The ways by which to do this is the core learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will impart. The Director of this seminar is Subhash Patel, a very senior regulatory professional and founder of New Jersey-based MD Reg Consulting LLC, which serves medical device industry clients in all aspects of global regulatory affairs specific to their needs.

To enroll for this highly valuable training session on how to successfully prepare 510(k)/Pre-IDE/IDE and PMA premarket submissions that secure clearances and approvals from the FDA, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~produc... . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

The grasp needed for preparing premarket submission that win regulatory approval

At this seminar, Patel will demonstrate the grasp that regulatory professionals in the medical devices industry need for working with the FDA officials during the review and approval process of their submission. He will offer a complete understanding of the major aspects of FDA premarket submissions.

While knowledge of the regulatory process is one thing; medical device companies also need to know how to set and state regulatory arguments for their device in a most convincing manner to the FDA reviewer. This knowledge will be part of this course. In the process of explaining how to prepare premarket submissions that win regulatory approval; Patel will also offer tips and suggestions to participants on how to work effectively with the U.S. FDA officials during review and approval process of their submission.

During the course of these two days, Patel will cover the following core elements of how to prepare premarket submissions. He will explain the following:

o  History and background of U.S FDA Laws and Regulations

o  Classify Your Device

o  Choose the Correct Premarket Submission for your device

o  Compile the Appropriate Information for your Premarket Submission

o  Author and Prepare your Premarket Submission

o  Submit your Premarket Submission to the FDA

o  Interact with FDA Staff during Review and Approval

o  Complete the Establishment Registration and Device Listing

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Howto...  

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Howto...

 

Views: 23

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Mark Nilson posted events
4 hours ago
Mansi Rao posted a blog post

Microsoft Security

Security Decades of experience In today’s complex and regulated environment, businesses need to focus on building more secure solutions that deliver value to their customers, partners, and shareholders—both in the cloud and on-premises. Microsoft has decades-long experience building enterprise software and running some of the largest online services in the world. We use this experience to implement and continuously improve security-aware software development, operational management, and…See More
4 hours ago
knorr kendra posted a blog post

How To Find Safe And Secure Auto Loan Company For Bad Credit

Car is a luxury and everyone desires to have a car but everyone cannot afford due to bad credit or no credit history. People want to purchase cars but due to bad credit history, they are unable to get a loan from the company. Thus it is important to find a car loan finance company that provides car loans to people even with bad…See More
7 hours ago
Training Doyens posted an event
Thumbnail

Executive Presence - Key to Getting Promoted at 26468 E Walker Dr, Aurora, Colorado 80016-6104

March 7, 2018 from 1pm to 2pm
OVERVIEWToo many managers do not have the promotable trait called Executive Presence. There are numerous definitions – some focus simply on the communication skills others focus on skills that are too tactical. Leaders need to project the Executive Presence to motivate and challenge their direct reports. Learn the key skills for Executive Presence – that reflect your readiness to be promoted.WHY SHOULD YOU ATTENDHas this happened to you?  You realize that everyone around you is getting promoted…See More
8 hours ago

Forum

Gig Economy

The career world has rapidly changed and these days, long-term careers and people working in just one job are slowly but steadily becoming a thing of the past. In fact, according to research, in the…Continue

Tags: field, engineer, IT, freelance, economy

Started by Mohd Azher yesterday.

How to Repair MySQL InnoDB Table That Has Issues?

When trying to run: delete IdentityRequest *I get an error of sailpoint.tools.GeneralException: null index column for collection: sailpoint.object.IdentityRequest.itemsDoing a select * from…Continue

Tags: course, sailpointonline, sailpoint

Started by Soujanya Naganuri on Tuesday.

Occupational Health and Safety 7 Replies

Health and safety are important aspects of an organisation’s smooth and effective functioning.  Did you know that workplace health & safety injuries cost Australian businesses over $60 billion…Continue

Tags: Safety, and, Health, Occupational

Started by WHS Solutions. Last reply by Tony Ferraro on Sunday.

About sailpoint software

An identity management system refers to an information system, or to a set of technologies that can be used for enterprise or cross-network identity management. Additional terms are used synonymously…Continue

Tags: sailpoint

Started by sujathayarlagadda Feb 16.

What can be essentials safety measures taken to secure campus?

Students safety inside and outside the school premises is a huge concern in today's risk environment. what measures should be taken to ensure campus security?Continue

Tags: security, campus

Started by Jen McDade Feb 6.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service