Who We Serve: Device Class
Class III Device Manufacturers
Class III devices carry the highest risk and the heaviest regulatory load. Approval usually depends on a premarket approval application, the facility is typically inspected before approval, and the obligations continue for the life of the device. We help Class III teams prepare for the pre-approval inspection and keep postmarket records ready for the next one.
Standards and Regulations to Know
- 21 CFR Part 814Premarket Approval
- 21 CFR Part 812Investigational Device Exemptions
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
- ISO 14971Risk Management for Medical Devices
- ISO 14155Clinical Investigation of Medical Devices in Human Subjects
- 21 CFR Part 803Medical Device Reporting
- 21 CFR Part 806Reports of Corrections and Removals
Typical Regulatory Exposure
Most Class III devices require premarket approval under 21 CFR Part 814, which rests on valid scientific evidence of safety and effectiveness, usually including clinical data. Clinical investigations of significant risk devices run under an investigational device exemption (21 CFR Part 812), and the sponsors, sites and monitors involved can be inspected under FDA's bioresearch monitoring program.
FDA typically inspects the manufacturing facility before approving a PMA. Compliance Program 7382.850 covers PMA pre-approval and postmarket inspections, which look at whether the design described in the application is the design being built, and whether the quality system can produce it consistently. Records that served well during development often fall short of this.
After approval, changes that affect safety or effectiveness generally require a PMA supplement before they are implemented, and approval orders can carry conditions such as post-approval studies. Periodic reporting, medical device reporting and corrections and removals reporting all continue, and some Class III devices are also subject to device tracking.
Where Audits Find Gaps
- 01
Application and Production Out of Step
Specifications, suppliers or process parameters changed after the PMA was filed, and the manufacturing records no longer match what FDA reviewed.
- 02
Process Validation Not Finished
Validation of special processes is still in progress, or relies on engineering runs that were never formally approved, at the point FDA arrives to confirm the firm can make the device.
- 03
Supplement Decisions Without Rationale
Postapproval changes were judged not to need a supplement but the reasoning was not recorded, or a change went into production before its supplement was approved.
- 04
Clinical and Quality Records Kept Apart
Adverse events from the clinical study and complaints from early commercial use are handled by different teams, with no single view feeding risk management.
- 05
Post-Approval Study Commitments Drifting
Enrollment, reporting and data management for required post-approval studies lag behind the conditions of approval, with no owner tracking them in the quality system.
Relevant Standards and Regulations
- 21 CFR Part 814Premarket Approval
- 21 CFR Part 812Investigational Device Exemptions
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
- ISO 14971Risk Management for Medical Devices
- ISO 14155Clinical Investigation of Medical Devices in Human Subjects
- 21 CFR Part 803Medical Device Reporting
- 21 CFR Part 806Reports of Corrections and Removals
Relevant Services
PMA Pre-Approval Inspection Preparation
Getting Class III manufacturers ready for the facility inspection that accompanies PMA review.
BIMO (Clinical) Inspection Readiness
Readiness for FDA bioresearch monitoring inspections of device clinical studies: sponsors, CROs and sites.
Mock FDA Inspection
A practice FDA inspection in our Inspection Simulator, with an advisor playing the investigator.
FDA Inspection Readiness (CP 7382.850)
FDA device inspection preparation built around Compliance Program 7382.850 and its risk-based approach.
CAPA System Remediation
Fixing a CAPA system auditors keep citing: the procedure, the records, root cause, effectiveness and backlog.
Audits and Inspections You May Face
FDA PMA Pre-Approval Inspection
An FDA inspection tied to a PMA application that checks your quality system and its match to the submission.
FDA BIMO (Clinical Investigation) Inspection
FDA inspection of a clinical investigation's sponsor, monitors, investigators or IRB under 21 CFR Part 812.
FDA Baseline Surveillance Inspection
FDA's comprehensive surveillance inspection of your quality system under Compliance Program 7382.850.
Questions
When should we start preparing for a PMA pre-approval inspection?
Ideally before the application is filed. The inspection checks that the facility can make the device described in the PMA, so manufacturing, validation and design transfer records need to be complete and consistent with the submission well before FDA schedules a visit.
Is a pre-approval inspection the same as a routine inspection?
It covers the same quality system, but the emphasis differs. Investigators compare the application against manufacturing reality and look closely at design transfer, process validation and production readiness. A mock inspection scoped to those areas is a useful rehearsal.
Who needs to prepare for a BIMO inspection of our clinical study?
The sponsor, the clinical sites and any contract research organization can each be inspected. We help sponsors check monitoring records, investigator agreements, device accountability and adverse event handling against what the IDE committed to.
Class III Device Manufacturers
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.
