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ADLM recently released a short overview on the FDA final rule on LDTs. This is a great summary if you haven't gotten around to read the 528 page document from the FDA just yet. You can find it here. A few points I would add to this:

1. Currently marketed LDTs (marketed prior to issuance of the final rule), while under enforcement discretion for stages 3-5 (quality system requirements and pre-market review) are still subject to stages 1 and 2 (registration, listing, labeling, and MDR reporting requirements).

2. Currently marketed LDTs may be modified, except for modifications that: 
• change the indications for use of the IVD;
• alter the operating principle of the IVD (e.g., changes in critical reaction components);
• include significantly different technology in the IVD (e.g., addition of artificial intelligence or machine learning to the test algorithm, a change from targeted sequencing to whole genome sequencing, a change from immunoassay to mass spectrometry, or a change from manual to automated procedures); or
• adversely change the performance or safety specifications of the IVD.

3. Premarket submission is not enforced for changes made to another manufacturer's 510(k) cleared or De Novo authorized test by high-complexity CLIA-certified/accredited laboratories, as long as these modifications would not require a premarket submission if they were made by the original manufacturer. For example, these modifications cannot significantly affect the safety or effectiveness of the device, operating principle, or intended use.

ADLM recently released a short overview on the FDA final rule on LDTs. This is a great summary if you haven't gotten around to read the 528 page document from the FDA just yet. You can find it here. A few points I would add to this:

1. Currently marketed LDTs (marketed prior to issuance of the final rule), while under enforcement discretion for stages 3-5 (quality system requirements and pre-market review) are still subject to stages 1 and 2 (registration, listing, labeling, and MDR reporting requirements).

2. Currently marketed LDTs may be modified, except for modifications that: 
• change the indications for use of the IVD;
• alter the operating principle of the IVD (e.g., changes in critical reaction components);
• include significantly different technology in the IVD (e.g., addition of artificial intelligence or machine learning to the test algorithm, a change from targeted sequencing to whole genome sequencing, a change from immunoassay to mass spectrometry, or a change from manual to automated procedures); or
• adversely change the performance or safety specifications of the IVD.

3. Premarket submission is not enforced for changes made to another manufacturer's 510(k) cleared or De Novo authorized test by high-complexity CLIA-certified/accredited laboratories, as long as these modifications would not require a premarket submission if they were made by the original manufacturer. For example, these modifications cannot significantly affect the safety or effectiveness of the device, operating principle, or intended use.