INSTITUTION PROFILE / BIOSENSORS
U.S. Food and Drug Administration (FDA)
The regulator at the door of the U.S. market for medical and diagnostic devices
The FDA is a U.S. federal agency, and medical devices fall to its Center for Devices and Radiological Health (CDRH). Biosensor products such as blood glucose meters and continuous glucose monitors (CGMs) must pass one of three premarket routes (510(k), De Novo or PMA) before they are sold in the United States, and they remain under FDA oversight of registration, quality systems and adverse-event reporting afterwards. The FDA does not write technical standards itself; it formally recognises standards written by others and uses them in its reviews. This profile looks at one question only: how much influence the FDA has over biosensors. It contains no advice on how to use any product or on any reader's personal health.
What this article covers
- The FDA in 30 seconds
- What kind of body it is: the four types of influence
- What it does for biosensors
- How far its influence reaches (powers and geography)
- Companies and organisations involved
- Outlook
- Glossary, references and claim-to-source audit
1. The FDA in 30 seconds
FULL NAMEU.S. Food and Drug Administration (FDA)
Center for Devices and Radiological Health (CDRH)CDRH is the FDA centre responsible for medical devices
Center for Devices and Radiological Health (CDRH)CDRH is the FDA centre responsible for medical devices
COUNTRYUnited StatesLocated in Silver Spring, Maryland (address on the FDA website)
TYPE OF BODYFederal regulatory agencyPart of the Department of Health and Human Services (HHS)
HISTORYCDRH: "more than 40 years"The CDRH annual report's wording. This profile does not cover the FDA's founding year
STAFFFDA-wide: 19,687 FTEFull-time equivalents in FY2024. CDRH's total headcount could not be confirmed in official documents
SCALE (CDRH)21,780 submissionsMedical device submissions received in 2025, and 25,530 registered firms (the annual report's figures)
ROLE IN BIOSENSORSPremarket review and postmarket oversight510(k), De Novo, PMA, registration, quality systems and the classification of in vitro diagnostic devices
REACHEvery manufacturer selling in the U.S.Including overseas companies. It does not reach other countries' rules
The one thing to grasp first
The FDA's "clearance" (510(k)), De Novo "grant" and PMA "approval" are three separate systems. The FDA itself calls a device found substantially equivalent through 510(k) "cleared", and uses "approval" for PMA Sourced. So saying simply that "the FDA approved" a product does not tell you which route it took. The second point is that the FDA's decision covers only whether a device may be sold in the United States. Selling in Japan or the EU requires separate procedures under each system (section 4).
2. What kind of body it is: the four types of influence
The "institutions" that appear in articles on biosensors (medical devices and in vitro diagnostics) do not make products the way companies do. They can be sorted into four types by the route through which they influence the industry. The FDA is a "policy and regulation" body.
3. What it does for biosensors
FDA device regulation sorts devices into Class I, II and III by risk, with controls tightening as the class rises. There are three main premarket routes, and blood glucose meters and CGMs have gone through one or another of them Sourced.
| Route | Who it is for | FDA's decision and review goal | An example on record in FDA databases |
|---|---|---|---|
| 510(k) Premarket notification | Devices that can show "substantial equivalence" to a legally marketed predicate. Mainly Class I and II | An order finding substantial equivalence is called "cleared". The MDUFA V goal is 95% of decisions within 90 FDA days | Stelo Glucose Biosensor System (Dexcom), K234070, found substantially equivalent on 5 March 2024. Product code SAF (an over-the-counter [OTC] iCGM for people not using insulin) |
| De Novo | New types of device with no predicate, at low to moderate risk | When the request is "granted", a new classification (Class I or II) is created and later 510(k) filers can use the device as a predicate. The goal is 70 to 90% within 150 FDA days | Dexcom G6 (Dexcom), DEN170088, received 8 December 2017 and granted on 27 March 2018. Classified under 21 CFR 862.1355 |
| PMA Premarket approval | The highest-risk devices, Class III | "Approval" follows when there is sufficient scientific evidence. The goal is 90% within 180 FDA days (where no advisory panel input is used) | Eversense CGM System (Senseonics), P160048, approved on 21 June 2018 (an implantable CGM) |
Note: "FDA days" are the calendar days a submission is under review, counted from acceptance (510(k), De Novo) or filing (PMA), as defined in the MDUFA performance report. Review goals are targets agreed under MDUFA V, not guarantees. The examples show review outcomes only; they do not rank products.
How CGMs are classified, and the performance requirements the FDA wrote
Among CGMs, the "integrated continuous glucose monitoring system" (iCGM), designed to work with smartphones, insulin pumps and other connected devices, is defined in 21 CFR 862.1355 as Class II with special controls Sourced. The special controls spell out the accuracy a clinical study must show. For the adult population, for example, in the 70 to 180 mg/dL range the lower one-sided 95% confidence bound on "the share of readings within ±15%" must exceed 70%, and on "the share within ±40%" must exceed 99% Sourced. These are regulatory requirements that manufacturers must demonstrate in a submission; they are not guidance on how to read any individual product's measurements.
A materials engineer's view: the requirements are written for the whole sensor
The requirements in 862.1355 are framed not around electrodes or enzyme membranes but around the accuracy of the sensor as a whole, consistency across the wear period, resistance to interfering substances, and measures that stop a sensor being used past its stated life Sourced. For a materials supplier, choosing materials and designing membranes are means of meeting those whole-system requirements; the FDA does not dictate material compositions directly. Whether a change of material needs a new review depends on the nature of the change and the device class, so it has to be checked case by case (this profile does not make that judgement).
In vitro diagnostics, home use, standards and quality
| Topic | What the primary sources say | Category |
|---|---|---|
| Responsible office | Within CDRH's Office of Product Evaluation and Quality (OPEQ), the Office of In Vitro Diagnostics (OHT7) is responsible for the total product life cycle of in vitro diagnostics. Its Division of Chemistry and Toxicology Devices (DCTD) is described as covering clinical chemistry devices, including diabetes-related ones | Sourced |
| CLIA categorisation | The FDA sorts laboratory tests by complexity under CLIA (the U.S. clinical laboratory law): waived, moderate or high complexity. A manufacturer can ask the FDA to recategorise a moderate-complexity test as waived (CLIA Waiver by Application). Certification of the laboratories themselves is handled by CMS, while the FDA's role is categorising tests and issuing related rules and guidance (CMS's description) | Sourced |
| Home use and OTC | For blood glucose meters there are separate guidance documents on the studies to include in a 510(k): one for OTC (home) use and one for prescription point-of-care use (both final versions of September 2020, replacing the 2016 versions). For iCGMs, OTC product codes (SAF and SBH) exist for people who do not use insulin | Sourced |
| Recognised standards | Under section 514(c) of the FD&C Act the FDA "recognises" private-sector standards, and manufacturers can use a declaration of conformity to meet submission requirements. The guidance states that using standards is not mandatory in premarket submissions unless a standard has been incorporated into regulation. For CGMs, CLSI POCT05 2nd edition (performance metrics for continuous interstitial glucose monitoring) is recognised as number 7-307, and IEEE/ISO 11073-10425 (CGM device communication) is also on the list | Sourced |
| Quality systems | 21 CFR 820 (the QMSR) was amended to incorporate ISO 13485 by reference as the quality system standard. It was published on 2 February 2024 and took effect on 2 February 2026 | Sourced |
| Wellness products | The General Wellness guidance (6 January 2026, replacing the 2019 version) says CDRH does not intend to examine low-risk products meant only for general wellness to see whether they are devices or meet premarket requirements, under stated conditions including being non-invasive (the guidance is non-binding). Blood glucose meters and CGMs are named as examples of products for medical purposes and fall outside it. Products whose outputs prompt clinical action are also outside it | Sourced |
| Laboratory developed tests (LDTs) | In May 2024 the FDA issued a rule treating LDTs as in vitro diagnostic products. On 31 March 2025 a federal district court vacated the rule, and in September 2025 the FDA restored the earlier regulatory text | Sourced |
| Fees (FY2026) | Standard 510(k) fee US$26,067 (US$6,517 for small businesses), De Novo US$173,782, PMA US$579,272 | Sourced |
A caution on reading the counts
FDA review counts change depending on how they are tallied. The annual report says CDRH "received 21,780 medical device submissions" in 2025, which covers many types of submission beyond 510(k) and does not state whether it is a fiscal or calendar year. Counting 510(k) decisions dated 2025 in the FDA's openFDA database (updated 21 September 2026) gives 3,225, of which 54 were in the clinical chemistry review panel (which includes glucose meters), and the panels related to in vitro diagnostics (clinical chemistry, microbiology, haematology, clinical toxicology, immunology and pathology) total 256 (about 7.9%) Our calculation. A review panel is an assignment in the classification system, not a formal marker of an in vitro diagnostic, and openFDA warns that its data are unvalidated.
4. How far its influence reaches (powers and geography)
| Aspect | What the FDA has | What it does not have |
|---|---|---|
| Powers | Review and decision before a device is marketed in the U.S. (510(k), De Novo, PMA). An applicant may not market a device until it receives an order of substantial equivalence. Establishment registration and device listing, the quality system regulation (21 CFR 820), and procedures for complaint reporting and advisory notices (21 CFR 803 and 806) | The power to write private-sector standards (the FDA only recognises them). The power to make guidance legally binding (guidance is labelled as recommendations). Deciding how a device is used in clinical practice |
| Geography | Devices imported or sold in the United States. Overseas manufacturing sites must also register and designate a U.S. agent | Whether a device may be sold in Japan, the EU or elsewhere, and other regulators' decisions (CDRH takes part in the IMDRF and MDSAP, but each country decides for itself) |
| Compulsion | Premarket review is a condition of sale for devices that require it | Use of standards is voluntary unless a standard has been incorporated into regulation. A declaration of conformity is one option |
| Scale | CDRH annual report: 264,670 regulated medical devices, 21,780 submissions, 25,530 registered firms and 124 novel devices authorised (2025). FDA-wide: 19,687 FTE (FY2024) | CDRH's total headcount and counts for in vitro diagnostics alone could not be confirmed in official documents |
| Review funding | CDRH's full-time equivalents (FTE) devoted to the MDUFA programme total about 1,719 in FY2025: about 1,338 funded by user fees and about 382 by budget appropriations | The power to set MDUFA (the framework of fees and review goals) on its own. MDUFA is reauthorised by Congress every five years after negotiation with industry |
Note: the FTE figures are our sum of the CDRH office values in Table E-2 of the MDUFA performance report Our calculation. The table covers FTEs tied to the MDUFA programme, not CDRH's headcount. The review goals above are those agreed under MDUFA V.
5. Companies and organisations involved
The companies that appear in FDA records do so as applicants to the FDA. The figure below places CGM records found in FDA's databases onto the three pathways.
| Organisation | Relationship with the FDA (what primary sources confirm) | Category |
|---|---|---|
| Dexcom, Abbott, Senseonics | Applicants in FDA's databases. Dexcom: Dexcom G6 (De Novo) and Stelo (510(k)). Abbott: FreeStyle Libre 3 (K212132, found substantially equivalent on 26 May 2022) and Lingo (K233655, 29 May 2024). Senseonics: Eversense (PMA). Our company profiles in this series cover these firms individually | Sourced |
| CLSI (Clinical and Laboratory Standards Institute) | The FDA lists CLSI's POCT05 2nd edition, among others, as a recognised standard. CLSI writes the standard; the FDA recognises it | Sourced |
| ISO and IEEE | The QMSR incorporates ISO 13485 by reference. ISO/IEEE 11073-10425 (CGM device communication) and others are on the recognised list | Sourced |
| CMS (Centers for Medicare & Medicaid Services) | Manages the certification of laboratories under CLIA. The FDA categorises tests by complexity (CMS's description) | Sourced |
| IMDRF and MDSAP | An international forum of regulators and an audit programme usable in several countries, in which CDRH takes part. The annual report says IMDRF membership grew to include 7 new regions in 2025 | Sourced |
6. Outlook
| What the evidence suggests | Primary information it rests on | Category |
|---|---|---|
| Quality system requirements have been built on ISO 13485 since 2 February 2026 | 21 CFR 820 (QMSR), published 2 February 2024 and effective 2 February 2026. CDRH put implementing the QMSR first on its 2026 plan | Sourced |
| The framework of review goals and fees (MDUFA V) runs through fiscal 2027. Negotiations for the next one (MDUFA VI) began in 2025 | The MDUFA performance report gives MDUFA V as FY2023 to FY2027. The CDRH annual report says MDUFA VI negotiations began in 2025. We could not confirm what the new terms will be | Not yet confirmed |
| The share of CDRH's MDUFA-related FTEs funded by user fees rose from 71.9% (FY2024) to 77.8% (FY2025). FTEs funded by budget appropriations fell from about 487 to about 382 | Our sum of Table E-2 of the MDUFA performance report. The annual report lists "adapting to staffing changes" among its 2026 aims | Our calculation |
| Review capacity looks set to depend more heavily on user fees and the agreed review goals | The change in share above. The reports' figures do not show what this means for review quality or duration | Inference |
| There were 7 510(k) decisions for OTC iCGMs (product codes SAF and SBH) between March 2024 and August 2026 (Dexcom 4, Abbott 2, Signos 1; two of them Special 510(k)s) | Our tally from the openFDA 510(k) API (updated 21 September 2026) | Our calculation |
| Submissions for home and retail CGMs are likely to continue | The count above. This is our reading of the run of SAF and SBH decisions since March 2024; no future filings are published | Inference |
| Whether a non-invasive sensor's blood glucose estimate can be treated as a general wellness product depends on its claims and outputs and cannot be settled in general | The conditions in the General Wellness guidance (6 January 2026). Blood glucose meters and CGMs are named as medical-purpose examples, and one example says a product with microneedles that penetrate the skin is not a low-risk wellness product | Inference |
| The FDA's policy on regulating LDTs has been halted by a court decision in 2025. We could not confirm what the FDA will do next | The Federal Register notice of 19 September 2025 records only the restoration of the earlier text | Not yet confirmed |
7. Glossary
- CDRH
- The FDA's Center for Devices and Radiological Health. It runs premarket review and postmarket oversight of medical devices.
- 510(k)
- A notification showing a device is substantially equivalent to a legally marketed predicate. The FDA's decision is called "cleared".
- De Novo
- A route for new types of low- to moderate-risk device with no predicate, creating a new classification. The outcome is "granted".
- PMA
- Premarket approval, required for the highest-risk Class III devices. The outcome is "approval".
- Special controls
- Device-specific requirements for Class II devices, on top of general controls, such as the accuracy conditions for iCGMs.
- Recognised standard
- A private-sector standard the FDA has formally accepted. Manufacturers may declare conformity to it, but using it is generally voluntary.
- MDUFA
- The Medical Device User Fee Amendments: the framework of submission fees and review goals that Congress renews every five years.
- CLIA
- The U.S. law on clinical laboratory quality. The FDA categorises tests by complexity; CMS certifies laboratories.
- QMSR
- The FDA's Quality Management System Regulation, amended to incorporate ISO 13485 and effective 2 February 2026.
8. References
- FDA CDRH Annual Report 2025: submissions, regulated devices, registered firms, novel devices authorised, MDUFA V review goals, 2026 plans and international activity. https://www.fda.gov/media/190779/download
- FDA Performance Report to Congress, Medical Device User Fee Amendments, FY 2025: the MDUFA V period, the definition of "FDA days" and Table E-2 (CDRH FTEs by office). https://www.fda.gov/media/191127/download
- FDA Overview of Device Regulation: Classes I, II and III and the premarket pathways. Updated 30 January 2026. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation
- FDA Premarket Notification 510(k): substantial equivalence and "cleared". Current as of 22 August 2024. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k
- FDA De Novo Classification Request: devices with no predicate at low to moderate risk, and "grants". Current as of 30 September 2025. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request
- FDA Premarket Approval (PMA): Class III devices and "approval". Current as of 16 May 2019. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma
- Electronic Code of Federal Regulations 21 CFR 862.1355, Integrated continuous glucose monitoring system: definition of the iCGM, Class II and the special controls. https://www.ecfr.gov/current/title-21/section-862.1355
- Electronic Code of Federal Regulations 21 CFR Part 807: sections 807.20 and 807.40 (registration, and U.S. agents for foreign establishments), 807.81 (when a premarket notification is required) and 807.100 (FDA action). https://www.ecfr.gov/current/title-21/part-807
- Electronic Code of Federal Regulations 21 CFR Part 820: section 820.10 (ISO 13485 incorporated by reference) and the Quality Management System Regulation (QMSR). https://www.ecfr.gov/current/title-21/part-820
- FDA De Novo database, DEN170088 (Dexcom G6; received 8 December 2017, granted 27 March 2018; 21 CFR 862.1355). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN170088
- FDA 510(k) database, K234070 (Stelo Glucose Biosensor System, Dexcom, 5 March 2024, product code SAF). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234070
- FDA PMA database, P160048 (Eversense CGM, Senseonics, approved 21 June 2018). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160048
- FDA (openFDA) openFDA Device 510(k) API: tallies by decision date, review panel and product code (data updated 21 September 2026), including the records for FreeStyle Libre 3, Lingo and the OTC iCGM product codes SAF and SBH. https://open.fda.gov/apis/device/510k/
- FDA Recognized Consensus Standards: Medical Devices (CLSI POCT05 2nd edition, recognition number 7-307; IEEE/ISO 11073-10425 and others). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
- FDA Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices (14 September 2018): section 514(c), declarations of conformity, and standards not being mandatory in general. https://www.fda.gov/media/71983/download
- FDA Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use, final guidance (September 2020). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/self-monitoring-blood-glucose-test-systems-over-counter-use
- FDA Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use, final guidance (September 2020). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/blood-glucose-monitoring-test-systems-prescription-point-care-use
- FDA General Wellness: Policy for Low Risk Devices (6 January 2026; replaces the version of 27 September 2019). https://www.fda.gov/media/90652/download
- Federal Register Medical Devices; Quality System Regulation Amendments (89 FR 7496, published 2 February 2024, effective 2 February 2026). https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments
- Federal Register Medical Devices; Laboratory Developed Tests (89 FR 37286, 6 May 2024). https://www.federalregister.gov/documents/2024/05/06/2024-08935/medical-devices-laboratory-developed-tests
- Federal Register Medical Devices; Laboratory Developed Tests; Implementation of Vacatur (90 FR 45134, 19 September 2025), reflecting the district court's order of 31 March 2025. https://www.federalregister.gov/documents/2025/09/19/2025-18239/regulation-identification-number-0910-aj05-medical-devices-laboratory-developed-tests-implementation
- Federal Register Medical Device User Fee Rates for Fiscal Year 2026 (30 July 2025): FY2026 fees and FDA-wide FTE. https://www.federalregister.gov/documents/2025/07/30/2025-14412/medical-device-user-fee-rates-for-fiscal-year-2026
- FDA OHT7: Office of In Vitro Diagnostics: the office and its divisions. Updated 21 September 2022. https://www.fda.gov/about-fda/cdrh-offices/oht7-office-in-vitro-diagnostics-office-product-evaluation-and-quality
- FDA CLIA Categorizations: test categories and the CLIA Waiver by Application. Current as of 17 July 2023. https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-categorizations
- CMS Understanding CLIA Certification, Accreditation & Test Complexity: the roles of the FDA and CMS. Page dated 31 August 2026. https://www.cms.gov/medicare/health-safety-standards/clinical-laboratory-improvement-amendments-clia/getting-started-clia/understanding-clia-certification-accreditation-test-complexity
- FDA About CDRH: its mission and position. Updated 10 September 2026. https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health
9. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| The CDRH mission and position, membership of HHS, and the FDA's location | Sourced | Reference 26 https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health Reference 19 https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments Reference 10 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN170088 |
| Classes I, II and III, the 510(k), De Novo and PMA pathways and their terms (cleared, granted, approval) | Sourced | Reference 3 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation Reference 4 https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k Reference 5 https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request Reference 6 https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma |
| Review goals (510(k) 95% in 90 FDA days, De Novo 70 to 90% in 150 FDA days, PMA 90% in 180 FDA days), the MDUFA V period (FY2023 to FY2027) and the definition of FDA days | Sourced | Reference 1 https://www.fda.gov/media/190779/download Reference 2 https://www.fda.gov/media/191127/download |
| No marketing until an order of substantial equivalence; registration and U.S. agent for foreign sites; when a premarket notification is required | Sourced | Reference 8 https://www.ecfr.gov/current/title-21/part-807 |
| 21,780 submissions, 264,670 regulated devices, 25,530 registered firms, 124 novel devices authorised (2025) and CDRH's "more than 40 years" | Sourced | Reference 1 https://www.fda.gov/media/190779/download |
| FDA-wide 19,687 FTE (FY2024) and the FY2026 fees (510(k) US$26,067, small business US$6,517, De Novo US$173,782, PMA US$579,272) | Sourced | Reference 22 https://www.federalregister.gov/documents/2025/07/30/2025-14412/medical-device-user-fee-rates-for-fiscal-year-2026 |
| The iCGM definition, Class II and the special controls (accuracy thresholds, consistency over wear, interferents, sensor-life controls) | Sourced | Reference 7 https://www.ecfr.gov/current/title-21/section-862.1355 |
| Stelo (K234070): substantial equivalence and product code SAF | Sourced | Reference 11 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234070 Reference 13 https://open.fda.gov/apis/device/510k/ |
| Dexcom G6 (DEN170088): De Novo granted, classification 21 CFR 862.1355 | Sourced | Reference 10 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN170088 |
| Eversense (P160048): PMA approval | Sourced | Reference 12 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160048 |
| FreeStyle Libre 3 (K212132), Lingo (K233655) and the OTC iCGM product codes SAF and SBH | Sourced | Reference 13 https://open.fda.gov/apis/device/510k/ |
| The Office of In Vitro Diagnostics (OHT7) and the Division of Chemistry and Toxicology Devices | Sourced | Reference 23 https://www.fda.gov/about-fda/cdrh-offices/oht7-office-in-vitro-diagnostics-office-product-evaluation-and-quality |
| CLIA test categories, the Waiver by Application, and laboratory certification by CMS | Sourced | Reference 24 https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-categorizations Reference 25 https://www.cms.gov/medicare/health-safety-standards/clinical-laboratory-improvement-amendments-clia/getting-started-clia/understanding-clia-certification-accreditation-test-complexity |
| The OTC and prescription point-of-care blood glucose guidance documents (final, September 2020, replacing the 2016 versions) | Sourced | Reference 16 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/self-monitoring-blood-glucose-test-systems-over-counter-use Reference 17 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/blood-glucose-monitoring-test-systems-prescription-point-care-use |
| How recognised standards work (section 514(c), declaration of conformity, use generally voluntary) | Sourced | Reference 15 https://www.fda.gov/media/71983/download |
| CLSI POCT05 2nd edition (recognition number 7-307) and IEEE/ISO 11073-10425 as recognised standards | Sourced | Reference 14 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm |
| The QMSR incorporating ISO 13485, published 2 February 2024 and effective 2 February 2026 | Sourced | Reference 19 https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments Reference 9 https://www.ecfr.gov/current/title-21/part-820 |
| The General Wellness guidance (6 January 2026) and glucose meters and CGMs as outside examples | Sourced | Reference 18 https://www.fda.gov/media/90652/download |
| The LDT rule (May 2024), its vacatur on 31 March 2025 and the restoration of 19 September 2025 | Sourced | Reference 20 https://www.federalregister.gov/documents/2024/05/06/2024-08935/medical-devices-laboratory-developed-tests Reference 21 https://www.federalregister.gov/documents/2025/09/19/2025-18239/regulation-identification-number-0910-aj05-medical-devices-laboratory-developed-tests-implementation |
| CDRH's IMDRF and MDSAP participation and its 2026 plans (QMSR, adapting to staffing changes) | Sourced | Reference 1 https://www.fda.gov/media/190779/download |
| CDRH's MDUFA-related FTE in FY2025 (about 1,719 in total: about 1,338 fee-funded, about 382 appropriations-funded) and the fee-funded share | Our calculation | Reference 2 https://www.fda.gov/media/191127/download |
| 510(k) decisions dated 2025 in openFDA: 3,225 in total, 54 in the clinical chemistry panel, 256 (about 7.9%) across the IVD-related panels | Our calculation | Reference 13 https://open.fda.gov/apis/device/510k/ |
| Seven 510(k) decisions for OTC iCGMs (SAF and SBH) between March 2024 and August 2026 | Our calculation | Reference 13 https://open.fda.gov/apis/device/510k/ |
| The four types of institution, and the mapping and choice of examples in Fig. 2 | Our calculation | Our own classification |
| The FDA's future policy on regulating LDTs after the vacatur | Not yet confirmed | Not stated in the references; this article does not estimate it |
| The content of MDUFA VI (fees and review goals) | Not yet confirmed | Not stated in the references; this article does not estimate it |
| The inferences in section 6 | Inference | This article's reading of references 1, 2, 13, 19, 21 and 22 |
Last updated 3 October 2026 / Troy Technical
All figures come from official documents of the FDA and CDRH, the Code of Federal Regulations, the Federal Register and the FDA's databases. Items marked "Inference" are this article's reading of the primary information. Nothing here is advice on how to use any product or on any reader's personal health.