1. Approval of the first CLIA exempted respiratory infectious disease joint testing product

On February 3, FDA approved the in vitro diagnostic product BioFire SPOTFIRE Respiratory (R) Panel, which is used to simultaneously detect and identify suspected COVID-19 infection and other respiratory viral and bacterial infections. This test was reviewed through 510 (k) and CLIA exemption channels, becoming the first respiratory infectious disease joint testing product to pass CLIA exemption.

2. Encourage the public to report the results of COVID-19's self-test online

On February 6, FDA updated its simple step-by-step guide, requiring the public to voluntarily and anonymously report the results of OTC household COVID-19 test antigen reagent to MakeMyTestCount website.

3. Promote the return of COVID-19 antigen products to traditional review

In early March, the FDA approved the De Novo classification application for the first coronavirus testing product, named Sofia 2 SARS Antigen+FIA, Sofia 2 SARS Antigen+FIA Control Swab Set. The FDA classified the device as Class II, Product code QVF, and adopted the pre market notification 510 (k) pathway.

4. Release COVID-19 Medical Device EUA Transition Guidelines

FDA issued the guidance document of COVID-19 Related Medical Device Emergency Use Authorization Transition Plan (final version), and the implementation date of the transition plan is the end of the COVID-19 public health emergency, that is, May 11, 2023. After November 7, 2023, the relevant authorization guidelines for emergency use during the COVID-19 epidemic will become invalid.

Manufacturers, distributors, medical institutions, medical care providers, patients, consumers and institutions need a certain time to switch from the proprietary policies and actions during the COVID-19 pandemic to a normal state. At the same time, in order to avoid the aggravation of product shortages and supply chain disruptions, FDA has set a transition period, which also ends the COVID-19 era.

5. Publish 510 (k) guidelines for orthopedic non spinal bone plates, screws, and washers

The FDA has issued a guidance document: Orthopedic Non Spinal Bone Plates, Screws, and Washers - Premarket Notification (510 (k)) Submissions, which outlines the key points that medical device manufacturers and other stakeholders need to consider when preparing their respective submissions for orthopedic non spinal bone plates, screws, and washers in the context of 510 (k) pre market notification pathways. This provides additional clarification for certain orthopedic device descriptions reviewed under 510 (k), including specific device recommendations to be considered, to ensure that the submitted information is comprehensive and covers all major aspects.

6. 2024 Fiscal Year Fee Inflation

Compared to the fiscal year 2023, the user fee for fiscal year 2024 increased by 9.5%, and the annual registration fee increased by 17.87%. Among them, the 510 (k) fee increased from $19870 to $21760; The preferential benefits for small and micro enterprises can still be continued. Taking 510 (k) as an example, small and micro enterprises charge 1/4 or 25% of the standard price, which can save up to 16000 US dollars.

Draft guideline 7.510 (k) three consecutive issues

7.Draft Guide 510 (k) Three consecutive issues

*"Best practices for selecting equivalent devices to support pre market notification 510 (k) submissions": proposes considerations for "best practices for selecting equivalent devices", focusing on the characteristics of equivalent devices, including: proven use of recognized methods, meeting or exceeding expected safety and performance, no unmitigated safety issues related to use or design, and no design related recalls.

*Pre market Notice 510 (k) Submission of Clinical Data Usage Recommendations: Consistent with the guidelines 510 (k) Plan: Evaluating Substantive Equivalence of Pre market Notices, providing additional clarification and background information for situations where clinical data may be required to prove substantive equivalence, aiming to improve safety, innovation, consistency, and facilitate effective review of 510 (k) applications (including clinical data).

*Evidence expectations for implantable device 510 (k)

8. Update guidelines to specify devices and materials that do not require biocompatibility testing

The FDA has updated its biocompatibility guidelines, "Use of International Standard ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process," to replace the 2020 final guidelines, specifying devices and materials that do not require biocompatibility testing. The guide mainly adds Appendix G-Biocompatibility of Certain Devices in Contact with Contact Skin, which involves the following content:

*Recommendations for the use of certain medical devices made from ordinary materials in contact with intact skin. The range of materials listed in Appendix G includes: polymers (such as plastic or silicone); Fabric (such as cotton or artificial silk);

*The applicant can use it to decide when to apply the strategies in Appendix G;

*The FDA recommends that the materials submitted before listing should include information and labels;

*How manufacturers use quality management systems and post market strategies, including procurement and production process control, as well as customer complaint audits, to identify biocompatibility issues.

9.Starting from October 1st, 510 (k) submissions for mandatory use of eSTAR

Starting from October 1, 2023, except for exemptions, medical device manufacturers must use eSTAR to submit their 510 (k) applications online on the CDRH portal website.

The eSTAR electronic submission template is currently the only available electronic submission template. It is a collection and combination of 510 (k) submissions, submitted in electronic form, closely synchronized with the "SMART" 510 (k) review memorandum template used in the CDRH (Center for Devices and Radiological Health) review.

ESTAR has highly automated features, including integrated databases (such as FDA product codes, FDA recognized consensus standards), target questions aimed at collecting specific data and information from submitters, and so on.

10. Release proposed rules and plan to regulate LDT

The FDA has issued proposed rules and solicited opinions on the regulation of Laboratory Developed Tests (LDTs) for LDT. The FDA proposes to revise relevant regulations to clarify that in vitro diagnostic products manufactured in laboratories are devices regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Based on this amendment, the FDA proposes a policy to gradually eliminate the exercise of discretionary power over LDTs, and in vitro diagnostic products produced in laboratories will be subject to the same enforcement methods as other in vitro diagnostic products.