Author: Yervant Chijian, Director, Team Lead Medical Devices / IVD, Australia
In the first half of 2023 the FDA published 123 guidance documents across its various centers. Of these, around 25% were from Center for Devices and Radiological Health (CDRH) and 30% were from the Center for Biologics Evaluation and Research (CBER). The guidance documents released included 43 final and 24 draft editions. There were a variety of areas covered with the new guidance documents.
The CDRH guidance documents included:
- Digital health
- Radiological health
- Toxicology
- Cardiovascular labeling
- Ophthalmic
- Orthopedic
- Physical medicine
- IDE/HUD/HDE
- IVDs
- Clinical
The CBER guidance documents cover areas such as:
- Blood products
- Clinical
- Gene therapy
- ICH efficacy/quality/safety
- Toxicology
- Digital health
- Real-world data
- Safety
- Administrative/procedural documents
Other notable guidance documents included six related to changes to Covid 19 policies and transition plans for public health as the pandemic eases and the public health emergency has reduced.
There is also a heightened focus by the FDA on digital health, with the release in June 2023 of Content of Premarket Submissions for Device Software Functions guidance, Cybersecurity in Medical Devices: Refuse to Accept policy in March 2023, and Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions in April 2023. Advances in software in or as a medical device have prompted regulators to tighten their oversight, particularly with regards to the inclusion of AI/ML in device software.
The FDA published a large number of guidance documents in February 2023 relating to the radiology specialty, which includes:
Assembler’s Guide to Diagnostic X-Ray Equipment
- Performance Standard for Diagnostic X-Ray Systems and Their Major Components
- Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
- Medical X-Ray Imaging Devices Conformance with IEC Standards
- Surveying, Leveling, and Alignment Laser Products.
A recent addition in the Orthopedic field was a new draft guidance document on Patient-Matched Guides to Orthopedic Implants published in June. The guidance provides recommendations regarding information that should be included in regulatory submissions for patient-matched guides to orthopedic implants. The document also provides recommendations that manufacturers should consider when developing their design process for these device types.
Finally, there were a couple of guidance documents related to clinical investigations and Animal studies. These were: A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers, in April, and General Considerations for Animal Studies Intended to Evaluate Medical Devices, in March. These highlight the FDA’s ongoing focus on clinical evidence.
FDA Guidance documents represent current thinking on a topic by the FDA. They are not legally binding, and manufacturers have the option of alternative approaches if those satisfy the requirements of the applicable statutes and regulations. However, adherence to guidance documents does assist in ensuring that any premarket submission will contain the required information for an efficient review by the FDA and, as such, an increased chance of success.
