26/27 January 2021
What is new in terms of FDA Guidelines or Draft Guidelines regarding medical devices? Following you will find a selection from the last 6 months.
Strategic considerations from the Center for Devices and Radiological Health (CDRH) are available up to the year 2015. The 12-page strategy paper should primarily support the acceleration of the development of medical devices. Moreover, it should enable the achievement of an appropriate balance between premarket and postmarket activities with regard to the criticality of the medical devices. On the latter topic, the FDA has also published a own 17-page draft guideline entitled "Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval".
The Medical Device Tracking Guidance replaces the previous version from January 2010. The respective tables for medical devices which must be "tracked" and those which mustn't have been updated.
The 15-page guideline "Types of Communication During the Review of Medical Device Submissions" describes four communication possibilities within the authorisation procedure and replaces an older document too ("Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements" dated February 2008). This guideline had already been available as a draft as of April 2012.
A 18-page draft guideline describes "Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials".
With regard to the paediatric use of medical devices, the FDA has finalised the following 12-page guideline: "Providing Information about Pediatric Uses of Medical Devices". The document primarily addresses questions relating to the authorisation procedure for this topic.
Another 12-page draft guideline deals with the authorisation area. This draft guideline is entitled: "Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices" and addresses the voluntary use of consensus standards to help to accelerate the submission procedure.
The deadline for comment on the new classification of medical devices (see our GMP News from 10 April 2014) has been extended from 23 June 2014 to 22 September 2014.
A 9-page draft guideline entitled "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices" informs about FDA's "current thinking" on the intercommunication of medical devices.
In turn, "authorisation" is addressed in the new - very extensive (42 pages) guideline: "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]". The final document replaces the draft from 27 December 2011. The objective of this guideline is to provide assistance for both the industry and the FDA itself with regard to the review of 510-K submissions particularly critical decision points within this procedure are identified and explained.
A draft guideline dated 13 December 2012 on "Design Considerations for Devices Intended for Home Use" has also been finalised. Over 27 pages, the guideline intends to help manufacturers with the design and development of medical devices used at home. This also includes Compliance questions about the safety and efficacy of the products.
A 19-page draft guideline on clinical studies entitled "FDA Decisions for Investigational Device Exemption Clinical Investigations" presents FDA's "current thinking". Among other things, the draft addresses sponsors, clinical staff as well as the FDA itself. This guideline should facilitate the start of a clinical study according to the 21 CFR 812 provisions.
The topics Unique Device Identifier (UDI) and Global Unique Device Identification Database (GUDID) now play a major role for the FDA which has developed a own webpage for these subjects. Beside a schedule for the implementation of UDI, you can also find guidelines and draft guidelines. There are two new guidelines: one on the "Unique Device Identification System: Small Entity Compliance Guide" which should provide support for smaller companies and the second one "Global Unique Device Identification Database (GUDID)" comprising 42 pages with general information about UDI and GUDID. This guideline replaces the draft of the same name from 24 September 2013 and the final version from 24 June 2014. Moreover, a Question & Answer document has now been published. In the meantime, videos on the topic are available on the CDRH Learn page.