Overview

United States of America (USA) is renowned for its most Regulated pathways for Medical Devices. Beginning in 1976, US has regularly updated its regulations for approval of Medical Devices. They are regulated by Centre for Devices and Radiological Health (CDRH) under Food and Drug Administration (FDA). FDA classifies Medical Devices into 3 risk-based categories (Class I, II and III) where Class I devices are low risk devices and Class III are high risk devices. This classification paves the decision of following Regulatory path i.e., pre-market notification [510(k)] or Pre-Market Approval (PMA).

US FDA constantly update its regulations to match the upcoming medical technologies like Medical Device Data Systems (MDDS), mobile medical devices, Mobile Medical Applications (Apps) and medical software or hardware attachments that are used as an accessory to a regulated medical device.    

Also, the agency has definite pathways for novel devices whose process differs from conventional approvals. While the ease in pre-approval process is evident, given the dynamic regulations, the manufacturers will need active tracking and timely implementation during the post-marketing life cycle. Failing to adherence will lead to issuance of Form 483 warnings and seizure of facilities.

Freyr has exclusive delivery center in US with professional team to provide Regulatory support for manufacturers in maintaining quality and safety needed for approval. Freyr’s intelligence experts keenly observe regulation updates and keep the clients informed about steps to be taken for product compliance with current standards in prolonged.

 

USA Market Entry for Medical Devices - Process Flow

US Medical Device Regulations

 

 

Freyr Expertise

  • Regulatory Assistance in Premarket Notification [510(k)] and Pre-Market Approval (PMA)
  • Guidance for De Novo Process
  • Medical Device Classification
  • Quality System Regulation (QSR) Compliance
  • US Local Agent Representation
  • Document Compilation and Submission
  • Review of Device Safety and Efficacy
  • Post-Market Surveillance

 

Summary

S.No

Requirement

United States

1

Regulatory Authority

FDA

2

Regulation

Title 21 Code of Federal Regulations
(21 CFR) Parts 800 - 1299

3

Risk Classification

Class I

Class II

Class III

4

Regulatory Pathway

Class I

Exempted

Class II

510(K)

Class III

PMA

5

Authorized Representative

US Agent required

6

Fee payable

Class I

$4,624*

Class II

$10,566*

Class III

$310,764*

7

QMS Requirement

Quality System Regulation (QSR)
(21 CFR part 820)

8

Assessment of Technical Data

Centre for Devices and Radiological Health

9

Validity of License

Unlimited

10

Labelling Requirements

21 CFR Part 801

11

Submission format

Paper & CD/DVD

12

Final Outcome

Class I

Establishment Registration

 

 

Class II

510(K) Clearance

 

 

Class III

PMA

13

Timelines

Class I

1 Month

 

 

Class II

9 - 12 Months

 

 

Class III

18 - 30 Months

14

Language

English

*The price is as per records at the time of documentation and is subject to change.