Content Detail

• Content META

  Title	FDA reclassifications will reduce burdens for some IVD manufacturers, labs
  ID	6088096
  External ID	7488639240
  Author	Unknown
  Published Date	Jan. 22, 2025, 11:01 a.m.
  Summary	Jan 22, 2025 The U.S. Food and Drug Administration (FDA) announced last year that it intends to reclassify "most" class III IVDs into class II. This process should be completed by November 2027 and w
  Tags	press-release
  URL	https://www.labpulse.com/compliance-regulation/policy-and-regulation/article/15712377/fda-reclassifications-will-reduce-burdens-for-some-ivd-manufacturers-and-labs
  Sentiment	Negative: 0.07854    Neutral: 0.89264    Positive: 0.02882
  Relevance	0.00985

• Content Details

  Content ID	3737890
  Key	6fd68e37-721c-4580-b09c-9a550a511998
  Content	Jan 22, 2025 The U.S. Food and Drug Administration (FDA) announced last year that it intends to reclassify "most" class III IVDs into class II. This process should be completed by November 2027 and will allow test manufacturers to seek 510(k) clearance or de novo authorization instead of premarket approval (PMA) for reclassified tests. What will this process look like? How will reclassification impact IVD manufacturers and laboratories that perform laboratory-developed tests (LDTs)? Christine P. Bump, Image courtesy of Penn Avenue Law & Policy. Overview of FDA device classification system All devices regulated by the FDA, including IVDs, are class I, II, or III. Classification is determined by the risk presented by the device, the intended use of the device, and the device's technology. These three factors determine the level of control necessary to provide a reasonable assurance of safety and effectiveness: Class I devices present a low level of risk and generally do not need premarket clearance, authorization, or approval from the FDA. But, all class I devices are subject to regulation by the agency. Manufacturers must comply with the FDA's "general controls," which include requirements for registration and listing, labeling, medical device reports, corrections and removals, and quality systems. Class II devices present a moderate level of risk. All class II devices must comply with general controls and, unless exempted, "special controls." Special controls include requirements for premarket data, labeling, performance standards, and postmarket surveillance. Class II devices generally require 510(k) clearance or de novo authorization; manufacturers must demonstrate compliance with special controls in these premarket review applications. Class III devices present a high level of risk or include new technology. Class III devices must generally obtain PMA approval, which is the most rigorous premarket review process for devices. In a PMA submission, manufacturers must provide valid scientific evidence demonstrating the device is safe and effective for its intended use. A PMA includes clinical trial data, nonclinical testing data, manufacturing information, performance specifications, and labeling. All class III devices must also comply with the FDA's general controls. The FDA's intention to reclassify 'most' class III IVDs The FDA's intended reclassification of "most" class III IVDs includes the majority of infectious disease and companion diagnostic IVDs. To down-classify class III devices into class II, the FDA must determine that PMA approval is no longer necessary to provide a reasonable assurance of safety and effectiveness. Instead, special controls, along with general controls, can now provide this assurance for a type of device. In September 2023, the FDA convened a meeting of the microbiology devices panel and sought recommendations regarding the potential future reclassification of three types of infectious disease IVDs from class III to class II: Qualitative human parvovirus B19 assays Mycobacterium tuberculosis (TB) assays Qualitative hepatitis B virus (HBV) assays According to the panel, there is enough information to support the down-classification of the first two types of tests, but more information is needed to determine whether special controls can be established for qualitative HBV assays. The FDA reclassification process and what it means for IVD manufacturers What does the reclassification process look like? For purposes of explanation, let's assume the FDA determines that qualitative human parvovirus B19 assays can be down-classified from class III to class II. The agency must do the following: Publish a proposed order in the Federal Register , with the proposed reclassification of qualitative human parvovirus B19 assays, a summary of the valid scientific evidence that supports reclassification, and proposed special controls. (Stakeholders can submit comments to the proposed order.) Convene a device panel meeting to seek recommendations regarding reclassification. (Stakeholders can submit comments to the device panel.) Consider the panel's recommendations and all stakeholder comments. Publish a final order in the Federal Register reclassifying all qualitative human parvovirus B19 assays as class II devices. This order will include a summary of the panel's recommendations, responses to stakeholder comments, the new classification regulation, and the special controls. An IVD manufacturer seeking to market a qualitative human parvovirus B19 assay after such devices are reclassified would submit a 510(k) instead of a PMA. The 510(k) must include information demonstrating that the new assay complies with the new reclassification regulation, including all special controls. IVD manufacturers that already hold PMA approval for qualitative human parvovirus B19 assays would not need to submit new applications to the FDA to keep their tests on the market. However, if such manufacturers make future changes to their tests, they would follow the processes for changes to a 510(k)-cleared device, not a PMA-approved device. This lessens the future burdens for IVD manufacturers that have obtained PMA approval. Relationship to the LDT final rule The FDA has not mentioned LDTs in the context of its intention to reclassify many class III IVDs. However, the proposed reclassification initiative appears to relate to the FDA's plan to regulate all LDTs as IVDs. Under the now-final LDT rule, the FDA requires PMA submissions for all class III LDTs by November 6, 2027 (stage IV of the enforcement discretion phaseout policy). The rule also requires 510(k) or de novo submissions for all class II devices by May 6, 2028 (stage V of the phaseout policy). If the FDA reclassifies the majority of infectious disease and companion diagnostic IVDs from class III to class II, fewer LDTs would require a PMA. This reclassification would decrease the burden on laboratories and the FDA when LDTs are subject to the full scope of device regulations. What should IVD manufacturers and clinical laboratories do now? The FDA's anticipated timeline of completing the reclassification process by November 2027 presents several challenges for IVD manufacturers and laboratories performing LDTs. Until reclassification for a device type is complete, manufacturers and laboratories cannot assume that a class III test will be reclassified into class II. Thus, if they are developing a test that is currently classified as class III (or performing an LDT that is considered a class III IVD under the final rule), they must proceed with plans to submit a PMA. Planning and preparing a PMA submission can take years. This means that many IVD manufacturers and laboratories may prepare PMAs but only be required to submit 510(k)s. Data generated to support a PMA may satisfy the new classification requirements, but manufacturers and laboratories must ensure that submissions comply with special controls and all other requirements under a new classification regulation. Though there is pending litigation against the FDA to vacate the final LDT rule, declare the agency is not authorized to regulate LDTs as devices, and enjoin FDA from enforcing the final rule, laboratories should continue to assume that FDA will regulate LDTs as devices. Thus, both IVD manufacturers and laboratories should follow the Federal Register and FDA's press releases for updates about the reclassification initiative. These stakeholders should also consider submitting comments to proposed reclassification orders and device panel meetings and attending the panel meetings. Christine P. Bump is the principal and founder of Penn Avenue Law & Policy in Washington, DC. A regulatory attorney with two decades of experience developing and implementing FDA strategies for devices, diagnostics, digital health platforms, and genetic and genomic tests, Bump has worked on LDT issues since 2004. She advises laboratories, academic medical centers, large corporations, and emerging companies. Bump has also served as regulatory counsel for a national diagnostic coalition, written several articles, and presented at numerous industry conferences. Reference Center for Devices and Radiological Health (2024). Intent to initiate reclassification process for most high risk IVDs U.S. Food and Drug Administration . Available at: https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-intent-initiate-reclassification-process-most-high-risk-ivds (Accessed: January 17, 2025).
  Content Reference URL	None

• Publisher

  Publisher Name	Labpulse.com (#4142)
  Publisher URL	https://www.labpulse.com/
  Description	None
  Trust Flow Score	6
  Citation Flow Score	20

• Data Source

  Data Source Name	Quantexa News (#5)
  Data Source Type	news
  Data Source URL	https://app.aylien.com/dashboard
  Description	Welcome to Quantexa News API — the most powerful way to aggregate, filter, and integrate global news data into your apps and models.
  Weight	10