27/28 April 2021
In irregular intervals, the team of CONCEPT HEIDELBERG publishes overviews over new FDA's Guidelines or Draft Guidelines regarding medical devices. In the following, you will find a selection from August/ September/ October .
The draft of a "Question and Answer document" (entitled "The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions & Answers") is new and provides proposals for the use of Good Laboratory Practice (GLP) under research and marketing authorisations for medical devices. The document contains 13 questions - more or less detailed - on 8 pages and, according to the document, those questions had been asked regularly in the past..
The UDI topic (Unique Device Identification) which is a code enabling the unique identification of medical devices has become of high importance for the FDA. In so far, the new provisions on UDI systems were published at the end of September in the Federal Register. The consequences of that have been explained in a great Compliance table which presents the implementation requirements until 2020. There is now guideline on the topic as a draft which contains information about the respective databases connected to the UDI system. The draft on this Global Unique Identification Database (GUDID) is 59 pages long, very extensive, and describes the key concepts of the database, marketing authorisation issues and requirements resulting from 21 CFR 11, in addition to the introduction into UDI. Yet, the guideline text itself is composed of "only" 26 pages. The remaining pages are dedicated to 4 appendices, and examples clarifying the complex matter. A list of acronyms and a glossary can be found at the end of the guideline. The "CDRH Learn Course List" also proposes an online course on the UDI topic.
In Europe, the question of handling health apps is being discussed too. The FDA finalised a draft from July 2011 on the question: "Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff". The topic is addressed in a 43-page document. Again, this 24-page guideline contains a range of appendices, like for example on limitation issues.