December 20, 2021
US FDA Published Medical Devices Guidance Documents for Fiscal Year (FY) 2022

The FDA’s CDRH (Center for Devices and Radiological Health) has published a list of medical devices guidance documents for the fiscal year 2022. This list of guidance documents conveys a degree of transparency (in terms of where the regulator plans to commit resources and potentially increase scrutiny over the coming year and how manufacturers may be impacted in terms of compliance) for the medical device applicants and registrants who are willing to enter the USA market.

The FDA CDRH has divided its list of guidance documents into three (03) sections:

  • The A-list: A list of prioritized device guidance documents the FDA intends to publish during FY2022
  • The B-list: A list of device guidance documents the FDA intends to publish as resources permit during FY2022
  • Retrospective Review List: A list of final guidance documents issued in 1982, 1992, 2002, and 2012

The A-list Final Guidance Topics Include:

  • Clinical decision support software
  • Post-market surveillance
  • Procedures for handling post-approval studies
  • Remanufacturing of medical devices
  • Policies regarding global UDI database requirements for certain devices
  • Electronic submission template for 510(k) submissions

The A-list Draft Guidance Topics Include:

  • Cybersecurity in medical devices
  • Content of Premarket Submissions for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD)
  • Voluntary Malfunction Summary Reporting (VMSR) program for manufacturers
  • Medical device shortages
  • Transition plan for medical devices issued Emergency Use Authorizations (EUAs) during the COVID-19 Public Health Emergency

The B-list Final Guidance Topics Include:

  • Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices
  • Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations

The B-list Draft Guidance Topics Include:

  • Human factors information content in medical device marketing submissions
  • Risk categorization for SaMD
  • Marketing submission recommendations for a change control plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled device software functions

While the aforementioned information is a short summary of the FDA’s CDRH guidance documents for FY 2022, there is much more in store to explore. Hence, the manufacturers willing to market their medical devices in the USA must ensure to abide by the FDA published guidance for compliance. Would you like to know more details of the FDA medical devices guidance documents for FY 2022? Contact us now! Stay informed. Stay compliant.

Category: