15/16 February 2024
At the end of 2012 the Center for Devices and Radiological Health (CDRH) published a list with the Guidances planned for the fiscal year 2013 (1 October 2012 to 30 September 2013).
The CDRH is the FDA department responsible for the regulation of medical devices. The relevant guidances, policies etc. of the CDRH are also the basis for FDA inspections of manufacturers of medical devices. The actual list comprises only one DIN A4 page. The introduction, the reasons for which the FDA publishes this list, questions concerning complementation and comments enlarge the document to three pages.
Interestingly, the CDRH divides the list as concerns priority in an A-list and a B-list. The Agency intends to publish the documents listed in the A-list first. Should there still be resources available after completing the A-list, it is planned to also publish the other documents in the year 2013. In a relatively pragmatic approach the FDA has put "Finalizing existing draft guidance documents" in the B-list.
Interestingly, the document also gives a reply to the question whether the CDRH expects to complete the planned list entirely. The answer is "no" without really saying "no". Delays might occur for instance because new, unplanned guidance documents must be issued due to current events or because staff is diverted to other priorities that were not foreseeable (such as activities concerning premarket submissions or postmarket problems). Interested stakeholders are invited expressly to comment on the relative priority of necessary FDA guidance topics to help prioritise the allocation of resources in a more customer-oriented way when new guidance topics are planned.
The document also cites a guidance that will be withdrawn in 2013 (The Review and Inspecton of Premarket Approval Applications under the Bioresearch Monitoring Program).
Conclusions: the FDA has made a declaration of intent with the publication of the list of planned guidances for medical devices for the fiscal year 2013. The list does not explicitly contain guidances addressed directly to the quality assurance system or to GMP.
For further information please see the complete list "CDRH Fiscal Year 2013 (FY 2013) Proposed Guidance Development" which is also comprising explanations.