FDA Consulting
Frequently Asked Questions

Look for FDA consultants with regulatory affairs credentials (RAC), direct experience in your product category (drugs, devices, food, or supplements), and a track record of successful FDA interactions. Ask about their experience with your specific regulatory pathway — whether that's 510(k) clearance, facility registration, or warning letter remediation. A good FDA consultant should explain your options in plain language and provide references from similar engagements.

An FDA consultant helps companies navigate FDA regulatory requirements — from initial facility registration and product listing through ongoing compliance management. This includes preparing for FDA inspections, developing regulatory submissions (510(k), PMA, ANDA/NDA), responding to FDA enforcement actions like warning letters and Form 483 observations, and establishing quality systems that satisfy FDA CGMP requirements. Learn about our FDA compliance services →

Costs vary based on scope. Simple FDA facility registration: $2,000–$5,000. Comprehensive 510(k) submission support: $25,000–$75,000. Warning letter remediation: $15,000–$50,000. Ongoing compliance retainers: $3,000–$8,000/month. We provide detailed scoping and fixed-fee quotes for every engagement — no surprises. Get a free consultation →

For medical devices, the best service depends on your device classification. Class I devices may only need registration and listing. Class II devices typically require 510(k) premarket notification — our 510(k) consulting covers predicate selection, testing strategy, and submission preparation. Class III devices require a PMA application. We also help with De Novo classification for novel low-to-moderate risk devices.

We offer comprehensive FDA consulting across all product categories: FDA facility registration and product listing, FDA inspection preparation and mock inspections, warning letter and Form 483 remediation, 510(k) and PMA submission support, ongoing FDA compliance management, regulatory strategy for drugs (ANDA/NDA), food facility FSMA compliance, dietary supplement CGMP consulting, and cosmetics regulatory guidance.

The best FDA regulatory consulting for medical devices combines deep knowledge of FDA's Center for Devices and Radiological Health (CDRH) with hands-on quality system expertise. Look for consultants with RAC certification, experience with your specific device type, and a track record of successful 510(k) clearances or PMA approvals. We bring both regulatory strategy and ISO 13485 quality system expertise — ensuring your quality system supports both FDA compliance and international market access.

The FDA's target review time is 90 days (FDA Decision Day), but total timeline from start to clearance is typically 6–12 months. This includes predicate device research, testing, submission preparation, and FDA review. Factors that extend the timeline include additional information requests and clinical data requirements. A pre-submission (Q-Sub) meeting with FDA can help clarify requirements upfront. Learn about our 510(k) consulting →

The 510(k) process is the FDA's premarket notification pathway for Class II medical devices. You must demonstrate your device is substantially equivalent to a legally marketed predicate device. The process includes: identifying appropriate predicate devices, conducting performance and biocompatibility testing, preparing the submission with device description and comparison tables, submitting to CDRH, responding to any additional information requests, and receiving a clearance letter (typically within 90 days of acceptance).

Your FDA regulatory pathway depends on your product type. For medical devices: Class I (510(k) exempt), Class II (510(k) premarket notification), or Class III (PMA). For drugs: NDA (new drug), ANDA (generic), or OTC monograph. For food: facility registration plus FSMA preventive controls. For dietary supplements: facility registration plus 21 CFR 111 CGMP. A regulatory assessment consultation can determine the optimal pathway for your specific product.

Dietary supplement FDA compliance involves meeting requirements under DSHEA and 21 CFR Part 111 (Current Good Manufacturing Practice). Key requirements include: facility registration with FDA, product listing, CGMP compliance for manufacturing and quality control, adverse event reporting, proper labeling (Supplement Facts panel, disclaimer language), New Dietary Ingredient (NDI) notification for novel ingredients, and avoiding drug claims in marketing materials.

Yes, most food facilities that manufacture, process, pack, or hold food for consumption in the United States must register with the FDA under the Bioterrorism Act and FSMA. This includes domestic facilities and foreign facilities that export food to the U.S. Key exceptions include farms, restaurants, and retail food establishments. Registration is free and must be renewed between October 1 and December 31 each year. Foreign facilities must also designate a U.S. Agent. Learn about FDA registration →

FDA CGMP requirements for dietary supplements are codified in 21 CFR Part 111. They cover: personnel qualifications and training, physical plant and grounds, equipment and utensils, production and process controls, quality control procedures with identity testing of all incoming ingredients, laboratory operations, holding and distribution, returned and rejected products, and record-keeping requirements. The rules ensure supplements are manufactured consistently and meet quality standards.

During an FDA inspection, investigators examine your facility, quality system documentation, manufacturing processes, complaint handling, CAPA procedures, and records. Inspections may be pre-announced or unannounced depending on the type. If deficiencies are found, the investigator issues Form 483 observations at close. You have 15 business days to respond. Serious or repeated deficiencies can escalate to warning letters, consent decrees, or import alerts. Learn about inspection preparation →

Responding to a Form 483 requires a strategic, documented approach within 15 business days. For each observation: acknowledge the finding, explain the root cause analysis you conducted, describe immediate corrective actions already taken, outline preventive actions (CAPA) with specific timelines and responsible parties, and provide evidence of corrections. Avoid being defensive or dismissive. A strong 483 response demonstrates management commitment and can prevent escalation to a warning letter.

An FDA warning letter is a formal notification that the FDA has found significant violations of FDA regulations at your facility. Warning letters are issued after inspections reveal serious deficiencies that were not adequately addressed. You must respond within 15 business days with a detailed corrective action plan. Warning letters are public documents and can affect your ability to obtain new approvals, import products, or win contracts. Learn about our remediation services →

You have 15 business days from receipt to submit a written response to the FDA. This response must include: specific corrective actions already taken for each violation, a timeline for completing remaining corrections, evidence that corrections are effective, and a commitment to preventing recurrence. We strongly recommend engaging an FDA consultant immediately upon receiving a warning letter — the 15-day window is short and the response must be comprehensive.

FDA pre-submission (Q-Sub) consulting typically takes 4–8 weeks to prepare the pre-submission package, followed by a 75-day FDA review period before the meeting. The process includes defining your questions for FDA, preparing the briefing document with device description and proposed testing, and rehearsing the meeting. This is one of the most valuable FDA interactions available — it provides written feedback on your regulatory strategy before you invest in full submission preparation.