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Do you have a low to moderate risk medical device that does not have a substantially equivalent predicate device? Are you trying to figure out how to navigate the regulatory pathway for marketing your device? Prior to 1997, with the...

The Special 510(k) program was established to create a more efficient review process (30 days instead of the 90 days for Traditional 510(k)s!) for certain changes subject to 510(k) submission requirements. FDA released a new guidance document that supersedes the...

ISO 14155 [Clinical investigation of medical devices for human subjects – Good clinical practice], as the name suggests, addresses good clinical practices for all pre- and post-market clinical investigations that determine the safety and performance of medical devices. The final...

Innovating the medical device regulatory process is a goal that the FDA’s Center for Devices and Radiological Health (CDRH) is constantly striving towards. Among several other programs introduced or changed over the past couple years, the National Evaluation System for...

With the up-classification of medical devices as per the new EU MDR, software used as a medical device has been affected the most. Under Rule 11: “Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes...

The new EU MDR and the new IVDR have some harmonized standards also known as recognized standards. The harmonized standards are those that are referenced in the Official Journal of the European Union. Devices that comply with these harmonized standards...

The term “cosmeceutical” has become popular in recent years to describe a cosmetic product that claims medicinal benefits. While those in the cosmetic industry use the term to advertise the ingredients and benefits of their products, the FDA does not...

With FDA’s Food Safety and Modernization Act (FSMA), importers were given greater responsibility for ensuring that imported foods are safe. The Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is a program that requires importers...

Clinical evidence is required to assure the safety and efficacy of a medical device for intended use pre-market. After an appropriate risk-benefit analysis, the device may still be placed on the market with the residual risk. The questions about residual...