KAMM & ASSOCIATES
International FDA Consulting
Assisting the Medical Device Community with FDA Regulatory Services
Working Worldwide Since 1990.
• 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.
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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