FDA to Continue Remote Regulatory Assessments after Pandemic Ends

During the pandemic, when inspectors couldn’t travel to labs and other sites, the FDA had to carry out assessments remotely. In the last two years, the agency has performed remote regulatory assessments (RRAs) for more than 1,470 domestic and 600 foreign entities. Although it was envisioned largely as a temporary measure, the RRA proved so successful that the agency has decided to not only continue, but expand its use after the pandemic.

The New FDA Draft Guidance

On July 22, the FDA issued a new draft guidance in Q&A form, explaining how and when it intends to perform RRAs going forward. “An RRA is an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements,” the guidance explains.

RRAs yielded “significant benefits” in helping the agency cut delays in approving or authorizing products during the pandemic. So, they’ll continue once the pandemic ends. As before, some RRAs will be mandatory, including requests for certain records under Foreign Supplier Verification Programs, and others will be voluntary, meaning that the establishment targeted for assessment can choose not to participate, in which case, the agency would have to use other assessment methods, potentially prolonging the clearance or authorization process. Declining a mandatory assessment is grounds for blocking importation of a product.

The guidance clarifies that FDA may initiate an RRA, including when: i.) it can’t conduct an inspection due to travel restrictions brought on by pandemics, natural disasters, or “other unstable situations making travel infeasible”; and/or ii.) it determines that an RRA will help it “conduct elements of establishment oversight or support regulatory decisions,” such as preparing for an already planned inspection or following up on a consumer complaint.

RRA vs Inspection

Technically, an RRA isn’t the same thing as an inspection. The big difference is that the agency doesn’t issue Form 482 or Form 483 warning letters to establishments it finds to be noncompliant. However, it can use RRA information to support market review, such as in issuing emergency use authorization (EUA) for lab tests and other COVID-19 products during the pandemic.

RRAs are designed to enhance, rather than limit or replace inspections, product submission or application assessments, and other established FDA compliance information gathering activities, the guidance explains. FDA won’t perform RRAs and inspections at the same time—when carrying out both activities at the same establishment, the inspection generally won’t start until the RRA ends, although the RRA might also be used as a follow up to an inspection.

The RRA Process

The guidance also explains how the RRA process will work. For voluntary RRAs: FDA will contact the establishment’s point of contact by email or phone. The agency may use the establishment’s registration, establishment information provided in a marketing submission, or additional information available to identify the point of contact, authorized official, or US agent. During initial contact, FDA will request that the establishment’s top management official at the site, or senior designee, provide written confirmation of the establishment’s willingness and ability to partake in the type of RRA requested. FDA will then work with the establishment to schedule virtual interviews and meetings, confirm technological capabilities, and request records or other information for review.

FDA will use Form FDA 4003 to request records or other information for mandatory RRAs.

The actual RRA, whether voluntary or mandatory, may include any combination of the following:

• FDA requests for and review of records, documents, and other information (such as electronic systems, and source records from non-clinical and clinical studies);
• Virtual meetings between FDA and responsible establishment personnel to review the information provided, the electronic systems, the establishment’s operations and/or the establishment’s standard operating procedures (SOPs); and
• Use of livestream and/or pre-recorded video to examine facilities, operations, data, and information.

****

Here are some of the key new FDA EUAs and clearances that were announced in July 2022:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s)	Product
DiaSorin	501(k) clearance to market Liaison MeMed BV, a high-throughput immune-response assay to differentiate between bacterial and viral infections
Predicine	EUA for Predicine SARS-CoV-2 RT-PCR Test
Werfen	510(k) clearance for Rotem Sigma Thromboelastometry System for bleeding management
Roche	Breakthrough device designation for Elecsys Amyloid Plasma Panel for Alzheimer’s
Roche	Clearance for Elecsys AMH test for anti-Müllerian hormone in human serum and lithium heparin plasma
US Centers for Disease Control and Prevention	510(k) clearance for Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set for monkeypox
Abbott	Clearance for Cholesterol2 test for quantitation of cholesterol in human serum or plasma run on firm's Architect C system
T2 Biosystems	Breakthrough device designation for T2Lyme panel
Healthy.io	510(k) clearance for home use of Minuteful kidney-damage test
Watmind USA	EUA for Speedy Swab Rapid COVID-19 Antigen Self-Test
Genabio Diagnostics	EUA for at-home, over-the counter Genabio COVID-19 Rapid Self-Test Kit
PreventionGenetics	Marketing authorization for POMC/PCSK1/LEPR companion diagnostic as a Class II device

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

New CE Markings in Europe

Manufacturer(s)	Product(s)
PamGene International BV	IOpener-NSCLC blood test to guide immunotherapy in advanced-stage cancer
DiaCarta	QuantiVirus SARS-CoV-2 & Flu A/B Detection Test to detect and distinguish SARS-CoV-2, influenza A, and influenza B
Molecular Health	MH Guide clinical decision support software
Roche	Elecsys HCV Duo test for hepatitis C virus (HCV)
Roche	Ventana DP 600 slide scanner for digital pathology
Hologic	Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
Hologic	Novodiag RESP-4 molecular diagnostic test
Applied Biosystems (part of Thermo Fisher Scientific)	TaqPath Respiratory Viral Select Panel tests for adenovirus, human metapneumovirus, rhinovirus and enterovirus, and parainfluenza virus
Accelerate Diagnostics	Accelerate Arc Module
BforCure	Bfast [SARS-CoV-2] RT-PCR pack – POC kit
BforCure	Bfast [Flu A/Flu B/SARS-CoV-2] RT-PCR kit - 48
Bio-Techne	RNAscope ISH Probe High Risk HPV test
Abacus Diagnostica	GenomEra PCR-based test kit for detecting viruses that cause viral meningitis, encephalitis, and herpes
Bosch Healthcare Solutions	Vivalytic MG, MH, UP/UU, test for four sexually transmitted infections
Grifols	Procleix Plasmodium assay, nucleic acid test detecting Plasmodium, the mosquito-borne parasite that causes malaria
Becton Dickinson	BD Max Respiratory Viral Panel, RT-PCR test detecting SARS-CoV-2, influenza A and B, and respiratory syncytial virus
Nadmed	Q-Nadmed kit for analysis of nicotinamide adenine dinucleotides (NADs), a class of metabolites
Anitoa Systems	Maverick qPCR system for monkeypox
Paige	HER2Complete breast cancer biomarker detection software

Other international clearances announced during the period:

Manufacturer(s)	Country(ies)	Product(s)
GeneMind Biosciences	China	GenoCare 1600, single-molecule DNA sequencer originally developed by Direct Genomics
CTK Biotech	World Health Organization	OnSite COVID-19 Ag Self Test
Novacyt	UK	Exsig COVID-19 Direct Real-Time PCR test