It is important and necessary to document Software for FDA Submissions

It is important and necessary to document Software for FDA Submissions2Software project management has an important tool in the Agile methodology. The Agile methodology developed as a product of the gradual efforts at arriving at a team based methodology of iterative software development. Because of its close association with software, in terms of suitability; Agile is to software development what Lean is to manufacturing. Among the many areas in which the Agile methodology is very well suitable and adaptable; healthcare is one, since it uses software heavily.

The Agile methodology is effective in helping software project managers anticipate and address major logjams of software project management, such as vulnerability and unpredictability. By preventing project delays; Agile helps to cut costs. Since flexibility is an important characteristic of Agile; it has the ability to accommodate and take in many new changes that take place as the project develops.

Another major benefit of Agile is that it prevents piling of work at later stages of the project by reviewing project progress at every stage by validating roles, steps and processes functions. This is absolutely useful in the backdrop of severe constraints of time and money, because of which it is highly preferred and rated by Project Managers.

Is Agile perfect?

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All these terrific advantages notwithstanding; Agile is not perfect. It is not suited in every setting and in every situation. If Agile has to be efficient and deliver its results optimally; it has to work in conditions where there is complete, tightly knit team coordination. In the absence of very active and strong participation from the team leaders, subject matter experts and stakeholders; Agile can prove less than suitable or successful.

Agile’s suitability for the healthcare industry is well-established. However, Agile, being a highly teamwork-dependent initiative can fail to deliver in the absence of one or more situations in which it thrives. In the absence of complete confidence by those using it in the healthcare industry of its role in saving money, time and other resources; the Agile methodology can be less than useful

Get to learn the applicability of Agile methodology to healthcare

Business.

The ways by which the healthcare industry can adapt and optimize Agile methodology for its use and overcome the deficiencies and shortfalls of this methodology for enhanced performance will be the topic of a very interesting two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance.

The Director of this seminar is Brian Shoemaker, who consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures, and has worked with companies in Germany and Switzerland as well as the U.S. Please register for this session by logging on to It is important and necessary to document Software for FDA Submissions. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Clarity on the suitability of Agile to IEC 62304

It is important and necessary to document Software for FDA Submissions3

A criticism that does the rounds in healthcare software industry circles is that Agile, because of its lack of documentation, runs counter to the lifecycle standards mandated in IEC 62304. Brian will clarify on this area and explain how clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution, which go into the IEC 62304 principles actually reinforce, rather than undermine the Agile methodology. The proof of this fact is that the AAMI Agile report (TIR 45) has stated that the proper application of Agile, with its emphasis on nimbleness and ongoing learning, into a quality system and safety risk management can blend with and expedite the fulfilment of regulatory expectations of well-documented development.

Contrary for popular belief, documentation in Agile actually helps in taking advantage of iterative development. How? Since the IEC 62304 does not specify any lifecycle model; documentation can grow out of the required iterative activities. Agile, by developing incrementally and preventing last minute anxieties and worries; is highly useful in many disciplines of healthcare such as hazard analysis. When risk management is included in iteration tasks; it becomes more robust and solid.

It is because of all these reasons that this is a session that professionals across a wide spectrum of positions such as Regulatory Specialists, Quality Assurance Specialists, Documentation Specialists, Test Managers, Software Team Leaders and Lead Developers, and Project and Program Managers ought not to miss out on.

They will get thoroughly familiarized on the applicability of the Agile methodology to software documentation for FDA submissions. Over these two days of this seminar, Brian will cover the following areas:

  • Agile vs IEC 62304: an apparent contradiction?
  • The role and value of documentation
  • The REAL regulatory requirements
  • Specific documents required for an FDA submission
  • Areas where most development processes bog down
  • Iteration – well suited for risk, usability, and design reviews
  • Key practices to bridge the Agile and regulated worlds
  • Agile is not only acceptable for medical device software, but can be clearly superior.

 

 

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