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
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
|
Labeling 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.
