KAMM &
ASSOCIATES
International FDA
Consulting
Assisting the Medical Device
Community with FDA Regulatory Services
Working Worldwide Since 1990.
Phone: +1-239-417-1727
Skype: fda_consult
Services Offered:
•
FDA
Submissions: 510(K), IDE, PMA, Product Reports. (Over 400 successful 510(k)
clearances) IMPORTANT! See additional
510(k) information below
•
Medical
Device License Submissions for CANADA: Canadian
Medical Device License Information
•
New
Service: Kamm & Associates is an
official FDA ESG (Electronic Submissions Gateway) Provider. Manufacturer and
Initial Distributor MDR reports must be submitted via an Electronic Submissions
Gateway.
•
GUDID
Submissions. Barcodes now required on
most medical devices. Unique
Device Identification
•
FDA
483 and WARNING LETTER: Strategies and Responses
•
cGMP
Compliance Programs: AUDITING - CONSULTING
•
FDA
Registration and Listings: FDA charges an annual fee for Establishment
Registration. The fee changes each year.
•
Official
FDA Correspondent and/or Agent for Non-USA firms More
information on US Agents
•
Validations:
Software, Process and Product.
•
Risk
and Hazard Analysis.
Daniel Kamm, P.E.
is a Senior Life Member
of IEEE and a Registered
Professional Engineer
IMPORTANT INFORMATION ABOUT 510(K)
PREMARKET NOTIFICATIONS
Documents required for a 510(k)
submission:
1.
Labeling,
including brochures, users manuals, and labels on the device. Drafts are OK. An indications for use statement should be
included in most labeling.
2.
Descriptive
information: Theory of operation,
schematic and construction diagrams, photographs, packaging, service
manuals. Proprietary information should
be marked "Confidential and Proprietary."
3.
Testing
information: Sterilization information
(if applicable), biocompatibility, safety, performance, clinical,
electromagnetic compatibility, compliance with applicable standards. FDA
Recognized Standards.
4.
Any
testing or information required by Guidance Document. Guidance
Document Search
5.
Software
information (if applicable) Software
Guidance
6.
Cybersecurity
has become an important issue for medical devices. Get advice here.
7.
Comparison
to similar devices legally marketed in the USA (i.e. predicate devices). We can assist with this. Also go to the FDA
website and review the 510(k) summaries for similar devices.
8.
Risk
analysis. We can assist with this.
Documents in electronic format
such as Word or Acrobat pdf are preferred.
Most image formats are acceptable including jpg and DICOM.
Notice: FDA has begun the work on harmonization
of the Quality System Regulation with ISO13485-2016
Medical Device User Fees payable
to FDA.
Fees must
be submitted to FDA before sending the 510(k) or PMA submission to FDA. This is
in addition to the fee charged by Kamm & Associates to produce, submit, and
track your submission. Medical Device User
Fees Reduced fees (except for annual
registration) are available for certain small businesses. To qualify for the
small business rate, the company must submit Federal income tax forms (for
itself, and all affiliates, partners, and parent firms), showing that its
annual sales and receipts do not exceed $100 million. Foreign businesses can
now qualify as a small business. There
are some exemptions from fees, for example devices used solely for pediatric
use. Call or email for details and an
application form.
KAMM
& ASSOCIATES invites you to take advantage of our no-nonsense approach to
pre-market notifications and achieving compliance with FDA Good Manufacturing
Practice requirements. Our internationally experienced staff is ready to assist
you to become compliant with the GMP/QSR regulations. Kamm & Associates was
formed in 1990 for the purpose of specializing in providing FDA regulatory
services.
TESTIMONIALS:
From Warning Letter recipient:
"Thank you for your capable assistance during the FDA inspection. I
understand that with your help, the outcome turned out to be a great success. I
really appreciate it. ....I should say a lot of the credit goes to you. I'm
looking forward to working with you again. Best regards, (President of
Company)." From 510(k)
applicant: "Mr. Kamm, the level of
your expertise, efficiency and care for your clients is unsurpassed. I feel so
privileged to have found you. Thank you!"
From GMP compliance client:
"I wanted to send you a note just to let you know we had a routine
inspection by the FDA this summer and all went very well. No negative observances or problems were found.
Thank you for your assistance with our Quality Assurance Program, it was extremely
helpful and effective."
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