FDA's Current Publications for Manufacturers of Medical Devices

In irregular intervals, the ECA publishes overviews over new guidances or draft guidances, webinars, general strategy papers and inspection outcomes of the FDA with regard to medical devices. In the following, you will find a selection of the last months.

A 6-page draft guideline explains how to handle patient-specific data obtained from medical devices. The draft has been published with the title "Dissemination of Patient-Specific Information from Devices by Device Manufacturers". 

Another 29-page draft guideline entitled "Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions" describes the benefit-risk assessments which may arise in the event of e.g. bottlenecks with regard to specific medical devices because the products don't meet the specifications or should be recalled. Also FDA inspection outcomes flow into such assessments. Moreover, the possible intersection with the risk management standard ISO 14971 is described. The draft both addresses the FDA itself and the industry.

In the summer, the FDA celebrated the 40th anniversary of the Medical Device Amendments. Jeffrey Shuren - Director of the CDRH - took a look back in his Remarks at FDA’s Celebration of the 40th Anniversary of the Medical Device Amendments.

A draft document explains within 48 pages the accompanying development of therapeutic products and in vitro diagnostics (IVDs): "Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product". The IVDs are used in those combinations to provide indications about the use of therapeutics. Among other things, the document addresses the co-development with regard to the marketing authorisation and the regulatory requirements to be observed by the sponsors and the things to consider for planning and performing clinical studies. The draft is directed to the respective FDA personnel and the industry. To complete this draft guideline, the FDA has also made available the slides of the webinar Draft Guidance on “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product".

The topic "Unique Device Identification" (UDI) has been an issue in the USA for a long time now. The implementation of UDI requirements is done according to risk classes staggered until 2020. The FDA has now released a guideline as a draft on the topic UDI entitled "Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)". When finalised, this guideline should support both labellers and FDA-accredited organisations - particularly with regard to the expected content and form of the UDI.

Concerning exceptions from UDI, the FDA has an own website called "UDI Exceptions, Alternatives and Time Extensions".

The FDA has finalised the guideline "Adaptive Designs for Medical Device Clinical Studies". Within 49 pages, the document describes for both FDA personnel and the industry (e.g. sponsors) how a design for a medical device clinical study should be set when it is aimed to be further developed considering the accumulation of knowledge without compromising the study's integrity and validity. The FDA also offered a webinar on this guideline. The slides presented have also been made available - see Final Guidance on Adaptive Designs for Medical Device Clinical Studies.

Additionally, two FDA's drafts are new: "Deciding When to Submit a 510(k) for a Change to an Existing Device" and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device". Both documents cover changes to already marketed medical devices. Explanatory notes on both draft guidelines can be found in the slides of the webinar entitled "Two Draft Guidance Documents Clarifying When to Submit a 510(k) for a Change to an Existing Device".

To bring more transparency to the marketing authorisation process (PMA), the FDA has released a 62-page guidance entitled "Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications". This document replaces another one from 2012 with the same title. Here again for in-depth explanation the slides of a webinar are available for download.

A 36-page draft document entitled "510(k) Third Party Review Program" presents FDA's current thinking on the topic third parties in the context of the marketing authorisation procedure. The document describes how third parties are recognised and denied. It helps to harmonise with other audit programmes - that's why it is also referred to the "Medical Device Single Audit Program" (MDSAP). Regarding the topic MDSAP, the FDA has added 10 training modules to its CDRH Learn website.

With its new guideline "Medical Device Reporting for Manufacturers", the FDA has replaced the previous version with the same title from March 1997. Over 53 pages, the guideline provides interpretation assistance concerning the requirements from 21 CFR 803 on "Reportable Events" such as adverse events or malfunctions related to the use of medical devices. A webinar was also organised around that guideline. The slides presented can also be downloaded for free from the FDA website.

In the course of a patient-individual medical treatment, more and more medical devices from 3D printers are used. The FDA recognised the situation and created an own website on that topic which has been just recently updated.