KAMM & ASSOCIATES
International FDA Consulting
Assisting the Medical Device Community
with FDA regulatory services, working worldwide.
Now celebrating 22 years of service!
Washington, D.C.: +1-301-541-8037
· FDA Submissions: 510(K), IDE, PMA, Product Reports. (Over 200 510(k)s cleared) Our 510(k) list
· 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 for FY2013 is $2575 USD. Note: Starting with FY2013, Initial Distributors and Repackager/Relabeler establishments will have to pay the fee.
· Official FDA Correspondent and/or Agent for Non-USA firms More information on US Agents
· Validations: Software, Process and Product.
· Risk and Hazard Analysis Overview of risk analysis
IMPORTANT INFORMATION ABOUT 510(K) PREMARKET NOTIFICATIONS
Documents required for a 510(k) submission:
- Labeling, including brochures, users manuals, and labels on the device. Drafts are OK.
- Descriptive information: theory of operation, schematic and construction diagrams, photographs, packaging, service manuals. Proprietary information should be marked "Confidential and Proprietary."
- Testing information: biocompatibility, safety, performance, clinical, electromagnetic compatibility, compliance with applicable standards. FDA Recognized Standards.
- Any testing or information required by Guidance Document. Guidance Document Search
- Software information (if applicable) Software Guidance
- Sterilization information (if applicable)
- Comparison to similar devices legally marketed in the USA (i.e. predicate devices). We can assist with this.
- Risk analysis. We can assist with this.
Documents in electronic format such as Word or Acrobat pdf are preferred.
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 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. Small business application form for FY 2013 (Starts October 1).
We deliver extraordinary value for your consulting needs.
KAMM & ASSOCIATES invites you to take advantage of our no-nonsense approach to 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 when we discovered that other consulting firms were charging their clients too much for FDA regulatory consulting services. We respect our client's budgetary limitations and charge less for our services. This is possible because we do not spend money on unnecessary expenses. We use the very same consultants that the expensive consulting firms use. We have a core of consultants, each having over 25 years of medical device experience, and a network that can build a cohesive team for virtually any project size or skill required.
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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