All You Need to Know About Regulatory Strategies

by | Sep 13, 2021 | Compliance, Consulting Group, FDA, Health Canada, Healthcare, MedTech, Quality, Quality Systems, Regulatory


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In the medical technology world, it is becoming more and more difficult for medical devices and products to be and stay compliant with the FDA’s regulations. The US is just one market; many organizations and devices are distributed internationally, including the EU and Canada, which are the most common markets. How do companies know all the different regulations of each market? The answer: a regulatory strategy.

A regulatory strategy outlines a pathway from research and development to interstate commercialization while staying compliant with the intended market’s regulations and policies. Additionally, a regulatory strategy outlines a potential budget from that research development stage all the way to the commercialization of a product or device in a particular market.

A pharmaceutical regulatory strategy helps clarify the type of submission and testing that a drug product requires. In this type of regulatory strategy, our consultants outline pre-IND and IND submissions, clinical investigations, pre-market submissions, and any requirements for market entry.

In our biologic regulatory strategy, our consultants lay the groundwork for expanded access, BLA submission, and other prerequisites to getting the product into interstate commercialization. Our consultants are highly skilled in knowing the development and the different regulations for biologics.

With our medical device regulatory strategy, consultants will provide a clear understanding of what medical agencies are wanting to see in an organization’s submission. Knowing that a class of a device, availability of predicate devices, and the technology all factor into medical device clearance or authorization. Our consultants also advise on the type of submission required, performance testing requirements, international performance standards, and any global requirements for market entry.

Is your organization ready to get a medical device or product on the right path to approval? Reach out to one of our consultants today at info@emmainternational.com or call us at 247-987-4497.

Abby McVay

Abby McVay

Research Analyst- Ms. McVay is EMMA International’s Research Analyst. She has experience in technical writing and clinical trials in many life science industries. She has experience with many different elements of quality and regulatory compliance. Ms. McVay holds a Bachelor of Science in Psychology from Manchester University as well as a Master of Science in Industrial and Organizational Psychology from Angelo State University.

More Resources

Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.
Sterilization of Medical Devices

Sterilization of Medical Devices

There are many ways to sterilize medical devices before use in the industry. The common methods utilized are steam, radiation, dry heat, ethylene oxide, and vaporized hydrogen peroxide. There are two methods of sterilization for medical devices recognized by the Food and Drug Administration (FDA), established and novel.

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