Regulatory information
Over the years, the required knowledge base for the regulatory affairs profession has increased in complexity, breadth and depth. The Food and Drug Administration (FDA) has expanded its compliance requirements to align with internationally harmonized requirements from the European Union (EU), International Conference for Harmonization (ICH), and others.
Professional competencies
Today’s regulatory professional must have competencies in product approval requirements, quality system requirements, product design and engineering requirements, and more detailed topics depending on the criticality and type of device or drug, and affected geographies. Read more about professional regulatory competencies.
Our regulatory services
Whatever your regulatory needs, Medical Devices and Pharma provides regulatory services to companies in the medical device and pharmaceutical industries. So if you find that you would like to add a regulatory professional to your team, or a team of regulatory professionals, we can help.
Laws, regulations and regulatory documentation can be difficult to understand and interpret, especially for companies and individuals that are new to the industry or not otherwise familiar with legal requirements and guidelines. Add to that the need to stay up to date with current regulatory news, information, and trends, and the complexity of the profession becomes even more daunting.
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We recommend that you bookmark this space, because Medical Devices and Pharma will provide updates on regulatory news and events, as well as solid interpretation, analysis, and opinions to help you navigate through the national and international regulatory environments.
510(k) Submissions
Let’s connect
Consider us as a colleague and advisor if you are planning a new product or product design change, are not completely sure about compliance requirements, or have regulatory enforcement issues that you need to resolve. Some examples of the services we provide follow. And if you have any questions about these or other regulatory areas of expertise, please contact us.
The Wolverine Peptide Stack: What We Know
Promoted for faster healing and injury recovery, two experimental peptides are attracting growing consumer interest despite limited human clinical evidence and unresolved safety questions.The promise sounds almost too good to be true: faster recovery from injuries,...
October 2026 Premarket Approval (PMA) Authorizations
Three original device approvals and 218 supplements / noticesFDA's October activity highlights three newly approved medical devices and the extensive regulatory oversight required to maintain and modify products already on the market.The U.S. Food and Drug...
Regulatory Information
The Wolverine Peptide Stack: What We Know
Promoted for faster healing and injury recovery, two experimental peptides are attracting growing consumer interest despite limited human clinical evidence and unresolved safety questions.The promise sounds almost too good to be true: faster recovery from injuries,...
October 2026 Premarket Approval (PMA) Authorizations
Three original device approvals and 218 supplements / noticesFDA's October activity highlights three newly approved medical devices and the extensive regulatory oversight required to maintain and modify products already on the market.The U.S. Food and Drug...
October 2026 FDA Premarket Notification Clearances
510(k) Clearances – Robotics, AI and Diagnostics Lead the WatchlistOverview FDA issued 295 premarket notification clearance decisions during October of 2026 The records include 293 K-numbered submissions and two BK-numbered donor-testing submissions, all with decision...
The Abbott NEC Case and Food Risk in Vulnerable Populations
What the Abbott NEC Case Reveals About Food Risk in Vulnerable PopulationsA companion analysis on how microbiological hazards, supplements, and clinical nutrition are reshaping regulatory expectations The recent $70 million verdict against Abbott Laboratories...
EU Notified Bodies
Role, Responsibilities, and Strategic Considerations for Medical Device Manufacturers Notified Bodies (NBs) are independent conformity assessment organizations designated by EU Member States and overseen by the European Commission. Under the EU MDR and EU IVDR,...
When a Small Process Failure Becomes a Patient Safety Event
What the Erbe Cryoprobe Alert Teaches Us About Modern Device Quality The FDA’s recent Early Alert regarding flexible cryoprobes manufactured by Erbe USA is a textbook example of a fundamental truth in medical device quality. That small manufacturing deviations can...
When Apparel Becomes a Medical Device
Lessons from FDA’s Breast Binder Warning Letters In December 2025, the FDA issued warning letters to several companies selling breast binders and chest compression garments online. The agency concluded that marketing claims on company websites, like statements about...
Testosterone Regulation Takes a Sharp Turn
Why FDA’s December Panel Raises Red Flags Regulatory Analysis The FDA’s regulation of testosterone therapy has long been a model of cautious, evidence-based policymaking. For more than a decade, the agency maintained a consistent position: testosterone was approved...
Invisible Outbreak of Contaminated Supplement Ingredients
Contaminated Products Distributed Nationwide How a contaminated Moringa shipment was spread across the U.S. supplement market, and why there were no additional recalls. Sam’s Club announced a recall of its Member’s Mark Super Greens powder in late October 2025 due...
Global Medical Device Reporting and Vigilance
International Medical Device Reporting Medical Device Reporting and Vigilance in the EU and Globally Timely and transparent reporting of medical device incidents is critical to protecting public health and ensuring continued confidence in healthcare technologies....