Preparing premarket submissions that win regulatory approval

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/~product_id=900776SEMINAR?wordpress-SEO .  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/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm

Standard Operating Procedures are crucial documents in the regulatory industry

 

Standard Operating Procedures (SOPs) are very important documents that can make or break an organization in the regulatory industry. In simple terms, a Standard Operating Procedure, as suggested in its nomenclature, is a description of a specific operational procedure in which all the activities necessary to complete tasks that conform to established best practices, set regulatory requirements for the particular industry, and the relevant State or local laws provincial laws are explained. Many a time, a Standard Operating Procedure can be just a description of the organization’s own mode of doing things related to its business.

So, this description leads to the fact that since a Standard Operating Procedure is a detailed description of how things are to be done by an organization; any such document in the medical devices industry contains a list of step-by-step procedures the manufacturing organization lays down for producing its products. In a larger sense, an SOP is a complete depiction of all the practices followed by a business that has to meet the required quality and regulatory standards.

Get trained on how to write Standard Operating Procedures effectively

Given the acute importance of Standard Operating Procedures; it is important for regulatory professionals to get a clear idea of how to approach them by getting a thorough understanding of this concept. A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is being organized to give a thorough understanding of how to write Standard Operating Procedures effectively for the medical devices industry.

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, who has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and who manages activities within the global regulatory and compliance space; will be the Director of this seminar.  To gain a clear understanding of the topic of Standard Operating Procedures for the medical devices industry, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900760SEMINAR?wordpress_seo . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A clear clarification of all the major issues and aspects relating to Standard Operating Procedures will be one of the core purposes of this seminar. Writing a Standard Operating Procedure should be simple, or at least, that is what it appears in theory. In reality though, writing Standard Operating Procedures or procedural documents is quite challenging in the regulated industries, because the Standard Operating Procedures have to take a whole host of procedures, processes, practices and factors into consideration.

The FDA requires “proof of establish” for writing Standard Operating Procedures

In order to make this easier, the Director of this seminar will make the participants of this seminar understand the cornerstone of writing Standard Operating Procedures, which for the medical devices industry, is what the FDA calls “proof of establish”. This is the foundation of FDA regulations and guidance documents for this industry, and consists of the entire array of activities pertaining to the practice of how to define, document (in writing or electronically) and implement that which is written.

Once this rationale for the Standard Operating Procedures is clear, the step-by-step set of instructions needed for performing a particular job or task in the regulated industries flows more easily.  This is the teaching David will instill at this seminar on Standard Operating Procedures.

Writing Standard Operating Procedures is not the end; implementing what is written is

This said, writing the set of Standard Operating Procedures is by no means the end of the work for regulatory professionals. Implementing that which has been created and are in the process of being created is much more vital. David will offer understanding of this aspect by presenting topics associated with how to write, format, execute, manage and globally harmonize Standard Operating Procedures. This is going to be explained keeping in mind the fact that SOP’s are the most popular documents audited by FDA and other Agencies, as well as by auditors and customers.

Standard Operating Procedures and GDP

This seminar on Standard Operating Procedures will also give a detailed understanding of Good Documentation Practices required by companies to ensure GMP compliance and the role played by Standard Operating Procedures in helping achieve the required level of compliance and quality.

This seminar will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The Director will show recent enforcement actions for Standard Operating Procedures related violations, most of which are documentation related. He will also emphasize the fact that Standard Operating Procedures work best when they are designed to achieve specific results, and will teach participants the ways by which to determine what business goals will be achieved through better management with Standard Operating Procedures and how those goals will be measured.

https://www.brampton.ca/EN/Business/BEC/resources/Documents/What%20is%20a%20Standard%20Operating%20Procedure(SOP).pdf

ISO 14971: 2012 and IEC 62304: 2006 mitigate risks in medical device software

ISO 14971:2012 and IEC 62304:2006 are related but different global standards for risk management pertaining to software used in medical devices. Judicious application of these two standards is the way to go for medical device companies.

ISO 14971 and IEC 62304:2006 are global standards that govern risk management and lay out regulations and guidelines for software used in medical devices. The need for regulation of software in medical devices arises from the fact that software is the heart of a medical device. It is the medical device’s software that ensures that the device performs its intended purposes. Hence regulation is of utmost importance to enable medical device and software organizations facilitate this in their products.

The ISO 14971: 2012 -a brief understanding

  • The primary aim of ISO 14971, the global regulatory compliance standard is to ensure that a medical device carries medical safety into it
  • This standard requires medical device manufacturers to undertake steps and measures by which they can foresee and eliminate risks in a medical device in the optimal manner
  • Taking off from the above point, ISO 14971 requires medical devices to take steps to at least mitigate risks to the best extent. The ISO 14971standard prescribes the processes necessary for enabling this.

The ISO 14971’s update in 2012

In 2012, the ISO carried out an update to the application of this standard within the European regulatory framework. This amendment to ISO 14971: 2012 is at the periphery and not at the core. Annex ZA is the main area in which this standard has been updated:

The use of the “As Low as Reasonably Practicable” (ALARP) approach is from now excluded in the risk acceptance process. This standard proscribes labelling as a risk control measure that can play a role in decreasing risk occurrence.

The IEC 62304:2006

The requirements for medical device software’s life cycle are stated in IEC 62304:2006. This standard’s group of activities, processes and tasks creates a common basis for the software life cycle processes in a medical device.

When it comes to the risk management aspect, IEC 62304:2006 supplements and strengthens ISO 14971. If ISO 14971 is the global standard for the development of medical software; IEC 62304:2006 standard is concerned with medical device software and their software lifecycle processes.

The following tripod of software-related issues forms the IEC 62304:2006’s foundation:

These three attributes form the backbone of the test of a medical device company’s successful compliance with the regulatory requirements. For a medical device company to be successful in applying ISO 14971:2012 and IEC 62304:2006; it has to implement a cross-standard and resourceful way of integrating activities covering these requirements documents.

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Dealing with medical device reporting and recalls

Medical device reporting and recalls have enormous benefits for the medical device company and the public if implemented properly. They can prevent use of defective devices and can be an important inoculation against stringent FDA actions.

Medical device reporting and recalls are a major FDA activity. Medical device companies have clear instructions on how to initiate medical device reporting (MDR) and recalls.

What is medical device reporting?

Procedures for medical device reporting are governed by 21 CFR 803, which has details regarding how a medical device company should go about its MDR.

Who have to make MDR?

The FDA deems it mandatory for these entities to report certain types of adverse events and product problems:

For the following entities, MDR is voluntary and is to be done when serious adverse events are detected in the medical devices they use:

  • Professionals
  • Patients
  • Caregivers, and
  • Consumers

These categories can also report issues relating to product quality, therapeutic errors and use errors.

What is a recall?

A recall can be either of these:

  • When a firm voluntarily removes or corrects an already marketed device that is found by the FDA to be in violation of its governing act on these devices, namely the Federal Food, Drug, and Cosmetic Act. Seizure of a medical device is an example of this kind of action.
  • A recall also happens when a firm voluntarily determines, after investigation, that a device is adulterated in some way. An example of this instance is misbranding, when a manufacturer discovers that the device is not fulfilling its intended use.

A recall is important for two reasons:

How does a medical device company report a recall?

Firms have to follow 21 CFR Part 806 when they have to reporting Medical Devices Recalls, as set out by The Center for Devices and Radiological Health. The Center makes it a requirement for a firm to report when the medical device is posing a risk to health. This has to be reported to the FDA District Office in which the firm is located.

Our webinars can help you gain more comprehensive knowledge of this topic and related ones. Click here (link) for details.

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Globalcompliancepanel Successfully Completed Seminar in Los Angeles -New FDA FSMA Rules

New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

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Implementing the 510 (K) correctly in compliance with the latest proposed FDA changes

A 510(K) is a premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective, meaning that which is substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA).

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There are three types of Premarket Notification 510(K)’s that may be submitted to FDA: Traditional, Special, and Abbreviated. Product modifications that could significantly affect safety and effectiveness are subject to 510(K) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance with 21 CFR 820.30 Design Controls. The FDA provides guidance on these.

Needed: A thorough understanding of these aspects and the FDA’s latest proposed changes

In accordance with the concern evinced by many industry groups and associations, the FDA introduced as many as 60 proposals in August 2010, into the manner in which the 510 (K) process could be expedited. This was done with the intention of accelerating the speed at which newly approved medical devices could be made available to patients across the country. However, with the number of proposals being too many and their scope being too wide; the medical industry suggested that the FDA select for implementation only those proposals that enjoyed the broad consensus of the stakeholders, such as increased reviewer training, development of specific and relevant guidance documents, and enhancements or improvements to the de novo review pathway, among other suggestions.

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An upcoming seminar by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance industries, will clarify on these areas taken up for immediate change by the FDA and place them in the right context. It will address key resources when making critical decisions. This seminar will offer important insights into the core areas of premarket notifications, as well as the Design Control requirements under QS regulations and Design Controls.

To enroll for this seminar, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900527SEMINAR.

The Director at this seminar is David R. Dills, a senior Regulatory Affairs & Compliance Consultant. David provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems.

An understanding of the core elements of the PMA

At this seminar, David will help participants understand how medical device manufacturers can locate a “predicate” device and go through the content and format of the 510(K), and offer an understanding of the De Novo process and the expectations for possibly marketing a low risk device, and the potential impact of FDA’s proposed changes to the 510(K) process and why manufacturers need to pay attention to these.

He will also offer understanding of all the crucial aspects of the PMA, such as the differences between the Traditional, Special and Abbreviated submissions, an understanding of the Substantial Equivalence and how it is applied, who is required to submit the application to FDA, where to submit the 510(K) and what to expect with the review and approval process, when a device company requires this process and when it does not, the applicable exemptions to the submission process and special considerations, and so on.

Applied Statistics for product and process evaluation in design and manufacturing

Evaluating product and processes is an imperative for almost all design and/or manufacturing companies. These are the reasons for which this evaluation needs to be made:

  • Managing risks
  • Validation of processes
  • Establishing product/process specifications to QC to such specifications
  • Monitoring compliance to such specifications

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Lack of proper and thorough grasp of and correct implementation of statistical methods leads a company to having to face significant increases in its complaint rates, scrap rates, and time-to-market. As a result, such companies churn out poor quality in their products, leading to lowered customer satisfaction levels, severely impacting their bottom line.

A learning session to help understand statistical methods

In order to help professionals in process and manufacturing meet challenges associated with statistical methods with greater confidence, GlobalCompliancePanel, a highly reputable provider of professional trainings for the regulatory compliance areas, is organizing a highly educative two-day seminar on the topic, “Applied Statistics, with Emphasis on Verification, Validation, and Risk Management, in R&D, Manufacturing, and QA/QC”.

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John N. Zorich, Statistical Consultant & Trainer, Ohlone College & SV Polytechnic, will be the Director at this seminar, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

To enroll for this seminar, participants can log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900537SEMINAR.

Hands on approach to statistical methods toolbox

The aim of this seminar is to offer a hands-on approach by which the participants could comprehend the ways to interpret and use a standard tool-box of statistical methods that consist of confidence intervals, t-tests, Normal K-tables, Normality tests, confidence/reliability calculations, AQL sampling plans, measurement equipment analysis, and Statistical Process Control.

The Director will equip the seminar delegates with clarity on how to accurately employ and administer statistical methods, which can be used as a launchpad for introducing new products.

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This two-day session will help participants understand the proper way of avoiding issues relating to these aspects of statistical methods. John will explain how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing by giving real life examples derived mainly from the medical device design/manufacturing industry.

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John will cover the following areas at this seminar:

  • FDA, ISO 9001/13485, and MDD requirements related to statistical methods
  • How to apply statistical methods to manage product-related risks to patient, doctor, and the designing/manufacturing company
  • Design Control processes (verification, validation, risk management, design input)
  • QA/QC processes (sampling plans, monitoring of validated processes, setting of QC specifications, evaluation of measurement equipment)
  • Manufacturing processes (process validation, equipment qualification).