Guidance on manufacturing non-surgical face masks

J

jham65

Registered
#1
#1
Due to Covid-19, my company (in USA) is considering starting manufacturing face masks. I have been searching and have not been able to find answers to the following questions. Any guidance would be welcome.

I understand surgical masks are considered class II by FDA. We currently are FDA registered and have cut and sew capabilities for class I orthopedic devices and do not want to move to class II.

1. Are non-surgical masks considered medical devices?
2. If so, are they class I?
3. If class I, are there any clean room requirements?
4. If not a medical device, are there any other requirements that anyone is aware of? I can only think of any claims that we could not make.
5. If we were to act as a contract manufacturer for the class II surgical mask, would they need to be made in a cleanroom?
 
QMS for Medical Device Companies
Elsmar Forum Sponsor
G

Golfman25

Trusted Information Resource
#2
#2
jham65 said:
Due to Covid-19, my company (in USA) is considering starting manufacturing face masks. I have been searching and have not been able to find answers to the following questions. Any guidance would be welcome.

I understand surgical masks are considered class II by FDA. We currently are FDA registered and have cut and sew capabilities for class I orthopedic devices and do not want to move to class II.

1. Are non-surgical masks considered medical devices?
2. If so, are they class I?
3. If class I, are there any clean room requirements?
4. If not a medical device, are there any other requirements that anyone is aware of? I can only think of any claims that we could not make.
5. If we were to act as a contract manufacturer for the class II surgical mask, would they need to be made in a cleanroom?
Click to expand...
Call the White House, FDA, your Senator so they can direct you to the proper person to grease the skids for you. Good luck.
 
M

MDRexpert

Involved In Discussions
#4
#4
Can someone explain how NIOSH plays role in approval of surgical masks?
Also, if someone can share a link or information on the CDC requirements for surgical as well as non surgical masks. The CDC governs NIOSH but what authority does CDC have ? and how do they interact with the FDA?

What are the audit requirements for CDC? and how do they enforce their authority in terms of non-compliance?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Informational MHRA – Virtual manufacturing of medical devices – Updated guidance Medical Device and FDA Regulations and Standards News 1
dgrainger MHRA guidance on Virtual manufacturing - version 2 EU Medical Device Regulations 1
M FDA News USFDA Final Guidance – Manufacturing Site Change Supplements: Content and Submission Medical Device and FDA Regulations and Standards News 1
Ajit Basrur FDA News FDA Guidance Document: Manufacturing Site Change Supplement US Food and Drug Administration (FDA) 0
Ronen E FDA issues draft guidance on additive manufacturing Other US Medical Device Regulations 1
P Startup Medical Device Manufacturing Company Guidance ISO 13485:2016 - Medical Device Quality Management Systems 7
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 1
B EU MDR Perscription product guidance EU Medical Device Regulations 1
John Broomfield Guidance on Safe Working During Covid-19 Pandemic Misc. Quality Assurance and Business Systems Related Topics 0
dgrainger Informational UK guidance on FSNs - May 2020 EU Medical Device Regulations 1
dgrainger Informational UK guidance on FSNs - Published 20 May 2020 Other Medical Device Regulations World-Wide 1
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
dgrainger Informational MHRA guidance update on withdrawal of Notified Bodies Medical Device and FDA Regulations and Standards News 0
M Advertising medical devices in the U.S - Advertising regulations or guidance documents Other US Medical Device Regulations 3
dgrainger Informational MHRA updated guidance: Clinical investigations of medical devices – guidance for manufacturers Medical Device and FDA Regulations and Standards News 0
rob73 MDCG guidance on class 1 devices and MDR EU Medical Device Regulations 0
U Product Lifecycle Procedure Guidance Design and Development of Products and Processes 7
J CEN/TR 17223:2018 Guidance on the relationship between13485 and MDR.. worth the money?? ISO 13485:2016 - Medical Device Quality Management Systems 2
M Informational EU – Ongoing Guidance development within MDCG Subgroups Medical Device and FDA Regulations and Standards News 1
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0
M Informational EU – EMA revised guidance – Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 201 Medical Device and FDA Regulations and Standards News 2
D Performance Qualification per GHTF Guidance Other Medical Device Related Standards 12
M Informational EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 2
dgrainger Informational MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Clinical Decision Support Software Medical Device and FDA Regulations and Standards News 0
M Informational DSVG 04 – Breast Implants – Guidance on the vigilance system for CE-marked medical devices Medical Device and FDA Regulations and Standards News 0
M Informational EU – DSVG 03 – Cardiac Implantable Electronic Devices (CIED) – Guidance on the vigilance system for CE-marked medical devices Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Patient Engagement in Design and Conduct of Medical Device Clinical Investigations Medical Device and FDA Regulations and Standards News 0
M Informational USFDADraft Guidance – Accreditation Scheme for Conformity Assessment (ASCA) Pilot Medical Device and FDA Regulations and Standards News 0
M Informational Several revised or updates USFDA guidance Medical Device and FDA Regulations and Standards News 0
M Informational USFDA final guidance – Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 0
M Informational FDA draft guidance – Safer Technologies Program for Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Special Premarket Notification [510(k)] Pathway Medical Device and FDA Regulations and Standards News 0
M Informational Final guidance – GUIDELINES on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carc Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Acceptance Review for De Novo Classification Requests Medical Device and FDA Regulations and Standards News 1
M Informational US FDA Final Guidance – Humanitarian Device Exemption (HDE) Program Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classificati Medical Device and FDA Regulations and Standards News 0
M Informational MHRA guidance – Assistive technology: definition and safe use Medical Device and FDA Regulations and Standards News 0
S IMDRF or still GHTF for STED and other guidance? Other Medical Device and Orthopedic Related Topics 4
M Informational US FDA draft guidance – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final guidance – Postmarketing Safety Reporting for Combination Products Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final guidance – Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions Medical Device and FDA Regulations and Standards News 0
M Informational MHRA guidance updated to reflect the mDR – Clinical investigations of medical devices – Biological safety assessment Medical Device and FDA Regulations and Standards News 1
M Informational TGA – Medical device cyber security guidance for industry Medical Device and FDA Regulations and Standards News 0
M Informational MHRA Guidance – Dental radiographic X-ray imaging: dose to patients Medical Device and FDA Regulations and Standards News 0
Similar threads
Top Bottom