Tag Archives: cosmetics

FDA Draft Guidance Addresses Medical Device Status of Microneedling Products

On September 15, 2017, FDA published a draft guidance document titled “Regulatory Considerations for Microneedling Devices” (Draft Guidance). The Draft Guidance describes when a microneedling product is a medical device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA) and discusses the regulatory pathway for microneedling devices. Interested parties have 60 days, … Continue Reading

EU Device Regulation Seeks to Enhance Legal Certainty Through Clarified Scope and EU-wide Classification of “Borderline” Products

The application of different regulatory regimes to so-called “borderline” products and regulatory gaps for certain products compromise both the protection of patient safety and the creation of the internal market in the European Union.  The European Commission has proposed a revision to the regulatory framework for medical devices that aims to increase the legal certainty … Continue Reading