In 2018, the US agreed to harmonize its domestic good manufacturing practices with agreed-to international standards in accordance with the Medical Device Single Audit Program (MDSAP). On Feb. 23, the Food and Drug Administration (FDA) made its contribution to that effort by publishing a
proposed harmonization rule for medical device quality management systems (QMS) standards.
The Proposed Rule
The newly proposed rule on quality system regulation would revise the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation (21 CFR part 820) to align more closely with international QMS regulatory rules. The proposal, which would be the first major update to CGMP since 1996, would withdraw part 820 and replace it with International Organization for Standardization (ISO) 13485, which the agency says is “substantially similar” to the current US regulations.
However, there would also be a few tweaks. The proposed rule would retain current part 820 requirements for device labeling and packaging operations, issues that ISO 13485 doesn’t address, given that many device recalls are related to labeling and packaging. The FDA also plans to include signature and date requirements for records, and ensure that companies meet reporting requirements for complaints and service activities.
Nor would the proposed rule affect the FDA’s authority to carry out inspections—although the agency indicated that it would modify its current approach to ensure that inspections carried out are faithful to the international requirements.
Next Steps
If the rule is finalized, it would take effect one year after it was published in the Federal Register, i.e., February 23, 2023. The FDA would also need to clarify the QMS requirements for combination products, make “conforming edits” to current regulations that refer to part 820, namely, part 4 (21 CFR part 4), update its IT systems, and revise its inspections policies.
Here are the important new FDA Emergency Use Authorizations (EUAs) and clearances announced in February 2022:
New FDA Emergency Use Authorizations (EUAs) & Approvals
| Manufacturer(s) | Product |
| Foundation Medicine (Roche subsidiary) | Approval for FoundationOne CDx test as companion diagnostic with Merck's Keytruda (pembrolizumab) |
| Foundation Medicine (Roche subsidiary) | Breakthrough device designation for FoundationOne Tracker test for circulating tumor DNA detection and molecular monitoring |
| Datar Cancer Genetics | Breakthrough device designation for TriNetra-Prostate blood test to detect early-stage prostate cancer |
| Fluidigm | EUA for Advanta Dx COVID-19 EASE Assay PCR-based test |
| Uh-Oh Labs | EUA for UOL COVID-19 Test |
| Streck | Clearance for MDx-Chex for BCID2 to verify performance of BioMérieux BioFire Blood Culture Identification 2 panel for sepsis |
| BioFire Defense | 510(k) clearance for BioFire Defense COVID-19 Test 2 |
New CE Marks & Global Certifications
Notable European CE certifications announced during the period:
New CE Markings in Europe
| Manufacturer(s) | Product(s) |
| Roche | Cobas SARS-CoV-2 Qualitative test |
| Roche | Cobas SARS-CoV-2 & Influenza A/B test |
| SeekIn | SeekInCare Cancer Detection Kit, DNA-based blood test for early cancer detection |
| Seegene | Allplex SARS-CoV-2 fast MDx Assay |
| Invitae | FusionPlex Dx genomic profiling panel |
| Invitae | LiquidPlex Dx genomic profiling panel |
| Abacus Diagnostica | GenomEra SARS-CoV-2 2.0 Assay Kit |
| MedMira | RevealCOVID-19 Plus Total Antibody Test |
| Omega Diagnostics | Visitect COVID-19 antigen test for self-testing |
| PathogenDx | DetectX-Cv+ test for simultaneous detection of SARS-CoV-2, variants of concern, variants of interest, new mutations, and emerging variants |
| Genetic Analysis | GA-map Dysbiosis test for use on Luminex Magpix instrument |
Other international clearances announced during the period:
| Manufacturer(s) | Country(ies) | Product(s) |
| Genetic Technologies | Australia | GeneType risk-assessment test for certain cancers |
| Yourgene | UK | Clarigene SARS-CoV-2 test |
| Novacyt | UK | PROmate COVID-19 2G Real-Time PCR test |
| CoSara Diagnostics | India | Saraq Hepatitis B Viral Load Kit |
| Binx Health | Canada | At-home COVID-19 nasal swab sample collection kit |
