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510(k) Exemption in US: what is not exempted for Medical Device Manufacturers

Congrats to manufacturer if one medical device is 510k exempted. 510k exempted applies to class I and II medical device. It means more or less a right away market access after basic regulatory listing.

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Unlike other markets where class I or class A is only needed to list without review. In US the simplest pathway to market covers class I and II. Here the official reason:

Exemptions to the premarket notification requirements of 510(k) apply only to those devices that have existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type.

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While achieving "510(k) exempt" status means your device is exempt from premarket notification (the 510(k) submission), significant regulatory obligations remain.

 

Here’s what manufacturers must do:

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1. Confirm Exemption & Manufacturing Controls​​

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Verify Classification: Ensure your device is explicitly listed as Class I or Class II and exempt by regulation (found in FDA's classification regulations, 21 CFR Parts 862-892). Check the specific limitations of the exemption (e.g., some exemptions exclude devices intended for implant or life-support).

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2. Establish Quality Management (QMSR=GMP)

 

Only the class I devices with an asterisk (*) under 21 CFR Parts 862-892 are also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198). class II devices are NOT exempt from GMP requirements.

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You should comply with the Quality Management System Regulation (QMSR), which harmonizes with ISO 13485:2016 (21 CFR Part 820).

 

This governs:

  • Medical device file

  • Design controls (if applicable to the device type)

  • Document control

  • Purchasing controls

  • Identification & traceability

  • Production & process controls

  • Facility & equipment controls

  • Acceptance activities (incoming, in-process, final)

  • Nonconforming product handling

  • Corrective & Preventive Action (CAPA)

  • Labeling & packaging controls

  • Handling, storage, distribution, & installation

  • Records management

  • Implement, maintain, and continually improve a compliant QMS.

  • Be prepared to demonstrate compliance during FDA inspections.

  • Key Focus Areas: Robust CAPA system, effective complaint handling, thorough device history records (DHR), strong supplier management, and management review.

 

3. Possible FDA Inspection:

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  • Routine Inspections: FDA conducts routine surveillance inspections ("BIMO" - Bioresearch Monitoring for clinical trials, and QSIT - Quality System Inspection Technique for QMSR compliance) of registered device establishments, regardless of 510(k) exemption status. Frequency is risk-based.

  • For-Cause Inspections: FDA will inspect if triggered by:

    • Adverse event reports

    • Customer complaints

    • Recalls

    • Tips from competitors or employees

    • Issues with other products from the same manufacturer

    • Past compliance problems

  • Inspection Focus: Primarily on QMSR compliance, complaint handling, MDR reporting, and recordkeeping.

 

4. Post-Market Surveillance Activities:

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  • Medical Device Reporting (MDR): Mandatory. Report serious injuries, deaths, and certain malfunctions to the FDA within strict timelines (30 calendar days for deaths/serious injuries, 5 days for corrections/removals that reduce risk, or 10 days for MDR reportable events requiring remedial action).

  • Complaint Handling: Establish and maintain procedures for receiving, reviewing, evaluating, and investigating complaints. Determine if the complaint is an MDR reportable event.

  • Recalls & Corrections: Promptly and effectively execute recalls or market corrections if devices are adulterated, misbranded, or present a risk to health. Notify the FDA.

  • Adverse Event Monitoring: Vigilantly monitor real-world device performance for potential safety signals.

  • Registration & Listing: Annually register your establishment with the FDA and list your exempt devices in the FDA Unified Registration and Listing System (FURLS).

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In Summary: "510(k) exempt" only means exemption from the premarket notification submission. Manufacturers must still:

  • Register their establishment and list devices.

  • Fully comply with the QMSR (21 CFR Part 820).

  • Be prepared for FDA inspections.

  • Vigilantly perform post-market surveillance (MDR, complaints, recalls).

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