An investigational device exemption (IDE) allows for investigational devices to be used in clinical studies to collect the proper safety and effectiveness data….
Sarah Koehler
How to Submit a 510K
Three types of Premarket Notifications can be submitted to the Food and Drug Administration (FDA) Traditional, abbreviated, and special 510Ks. The traditional 510K program is utilized to seek marketing authorization for any device. When submitting a 510K there is not a form to submit however submission requirements can be found under 21 CFR part 807.
Woman’s Health and Infertility
In honor of this week being National Women’s Health Week, it is important to touch on the topic of infertility....
Electronic Post Market Safety
The Food and Drug Administration (FDA) recently finalized the guidance for post-market safety reports of biologics and...
Magnesium and High Blood Pressure
The Food and Drug Administration (FDA) recently debuted a new eligible health claim for magnesium. In early January...
Initiation of Risk Assessments
Risk Assessments are a powerful tool used to elevate regulatory decisions and product changes. Risk assessments are...
Principles of Data Integrity
Data integrity is one of the most critical factors in any regulated industry. This is because any data error could...
Over-the-Counter Products
Non-prescription drug products are classified as over-the-counter (OTC) drug products. OCT products are drugs that are...
Types of Combination Products
A combination product is a product composed of two or more regulated components. Examples of combination products...
Unapproved Drugs
Unapproved prescription drugs propose a significant risk for patients since they haven’t been reviewed for quality,...
Medical Device PMA
In 1976, the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Acts established three regulatory...
Medical Device Single Audit Program
In 2016 the Medical Device Single Audit Program (MDSAP) was initiated. Having a global approach to monitoring and...
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