Who We Serve: Business Model
Reprocessors, Refurbishers and Servicers
Work done on a device after it leaves the factory can be servicing, remanufacturing or reprocessing, and the name a firm gives it does not decide which. FDA looks at what is actually done to the device. We help reprocessors, refurbishers, servicers and OEMs work out where their activities fall and keep the quality records each one needs.
Standards and Regulations to Know
- 21 CFR Part 807Establishment Registration, Device Listing and Premarket Notification (510(k))
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
- 21 CFR Part 803Medical Device Reporting
- 21 CFR Part 806Reports of Corrections and Removals
- ISO 17665Moist Heat Sterilization
- ISO 11135Ethylene Oxide Sterilization
- EU MDR (Regulation (EU) 2017/745)European Union Medical Device Regulation
- ISO 14971Risk Management for Medical Devices
Typical Regulatory Exposure
Reprocessing a single-use device that has been used on a patient is a registrable activity (21 CFR 807.20(a)(4)), and FDA regulates third-party reprocessors and hospitals that reprocess single-use devices in the same manner as the original manufacturer. Since the Medical Device User Fee and Modernization Act of 2002, a 510(k) for a reprocessed class I or class II single-use device generally has to include cleaning, sterilization and functional performance validation data covering the maximum number of times the device is reprocessed, and the labeling must identify the reprocessor. Reporting, corrections and removals, and the QMSR apply as they would to the original manufacturer.
FDA's final guidance Remanufacturing of Medical Devices (May 2024) draws the line for reusable devices. Remanufacturing significantly changes a finished device's performance or safety specifications, or its intended use, and remanufacturers are manufacturers, with their own registration and listing and any marketing authorization required. Servicing returns a device to the original manufacturer's specifications, and the guidance describes refurbishing as restoring a device to those specifications without significantly changing them. FDA focuses on the activity performed, not on what a firm calls itself, and the guidance does not address reprocessed single-use devices.
For original manufacturers of reusable devices, FDA's guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (2015) sets out recommendations for validated cleaning, disinfection and sterilization instructions in labeling. Those instructions are design outputs and need validation evidence and change control like any other. In the EU, MDR Article 17 allows reprocessing of single-use devices only where national law permits it and treats the reprocessor as the manufacturer, with a derogation Member States may apply to reprocessing within a health institution.
Where Audits Find Gaps
- 01
Servicing That Became Remanufacturing
A repair, upgrade or replacement part changed performance or safety specifications, and nobody assessed whether that made the activity remanufacturing with its own registration and clearance needs.
- 02
Reprocessing Cycles Not Counted
Reprocessed single-use devices are not tracked by the number of times each has been reprocessed, so the validated maximum cannot be enforced.
- 03
Validation Built on a Different Model
Cleaning and functional validation used a device model or revision that differs from the one now being reprocessed, with no documented assessment of the difference.
- 04
Reprocessing Instructions Never Validated
An OEM's labeled cleaning and sterilization instructions were written from experience rather than validated, or were not revalidated after a design change.
- 05
Incoming Devices Accepted Without Criteria
Devices received for repair, refurbishment or reprocessing are accepted or rejected by judgment, with no written criteria for damage, wear or missing parts.
- 06
Service Findings Not Fed Back
Failures found during servicing or reprocessing are fixed but never analyzed as complaints or trends, which ISO 13485 Clause 7.5.4 expects.
Relevant Standards and Regulations
- 21 CFR Part 807Establishment Registration, Device Listing and Premarket Notification (510(k))
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
- 21 CFR Part 803Medical Device Reporting
- 21 CFR Part 806Reports of Corrections and Removals
- ISO 17665Moist Heat Sterilization
- ISO 11135Ethylene Oxide Sterilization
- EU MDR (Regulation (EU) 2017/745)European Union Medical Device Regulation
- ISO 14971Risk Management for Medical Devices
Relevant Services
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
FDA Inspection Readiness (CP 7382.850)
FDA device inspection preparation built around Compliance Program 7382.850 and its risk-based approach.
Submission Readiness (510(k), De Novo, PMA, Pre-Sub, 513(g))
The design, risk and V&V evidence behind a 510(k), De Novo or PMA, organized and gap-checked.
CAPA System Remediation
Fixing a CAPA system auditors keep citing: the procedure, the records, root cause, effectiveness and backlog.
Internal Audit Program
A risk-based internal audit program, run by your team or our advisors, with reports written for FDA to read.
Audits and Inspections You May Face
FDA Baseline Surveillance Inspection
FDA's comprehensive surveillance inspection of your quality system under Compliance Program 7382.850.
ISO 13485 Surveillance Audit
The periodic audits, at least annually, that support continued ISO 13485 certification between renewals.
EU Notified Body Audit (Including Unannounced Audits)
Conformity assessment, surveillance and unannounced audits by an EU notified body under the MDR or IVDR.
Questions
Is refurbishing a device the same as remanufacturing it?
Not under FDA's 2024 remanufacturing guidance. Refurbishing restores a device to the original manufacturer's specifications. Remanufacturing significantly changes the device's performance or safety specifications, or its intended use, and makes you a manufacturer of that device. The guidance includes worked examples, and your documented assessment is what an auditor will ask to see.
Our hospital reprocesses single-use devices. Does FDA treat us as a manufacturer?
Yes. FDA regulates hospitals that reprocess single-use devices in the same manner as the original manufacturer, which includes premarket, labeling, reporting and quality system requirements. If you reprocess in-house, you need the same validation and quality records a third-party reprocessor would keep.
What validation does an OEM need behind its reprocessing instructions?
FDA's 2015 reprocessing guidance recommends validated cleaning, followed by disinfection or sterilization as appropriate, with instructions users can follow. Auditors look for validation reports that match the current device design and labeling, and for a change control step that revisits them.
Reprocessors, Refurbishers and Servicers
Get an Advisor's View of Your Quality System
Tell us about your devices and the audit or inspection ahead, and an advisor will scope an assessment for your kind of product. Please don't send confidential documents yet: secure upload is set up after onboarding.
