Compliance / Regulatory: Food and Drug Administration: Calfee

Manufacturers and sellers of food, drugs, cosmetics and medical devices are governed by the Food and Drug Administration, the agency that enforces the Food, Drug, & Cosmetics Act (FDCA) and its regulations. Although food manufacturers and medical device manufacturers appear to have very different products, they are regulated by the same network of laws that govern any product that comes into contact with humans. Because of the potentially dangerous health effects of the products it regulates, the FDA has implemented numerous regulations that define a complex registration and reporting process for the products under its control.

We represent companies in the food and cosmetics industry, pharmaceuticals distributors and consultants, and medical device manufacturers and aid them in their efforts to comply with the FDCA. We aid clients in medical device and new drug registration and compliance, labeling and warning, food facility regulation and management, and general reporting. We also represent companies embroiled in litigation concerning FDA-regulated products.

Services

Our services include:

Consultation concerning the applicability of the FDCA to a client’s products.
Negotiation and communication with the FDA and state law equivalents concerning product registration, regulation and compliance.
Preparation and filing of required forms and reports with the FDA, including everything from Food Facility Registration forms and renewals to Adverse Event reports.
Consultation with respect to the approval and clearance process for medical devices and new drugs.
Preparation, filing and monitoring of Section 510(k) Pre-Market Notification Submissions.
Preparation and filing of, or defense against, FDA Citizen Petitions.
Review and preparation of FDA-required labeling for all food, drugs and cosmetics, including review and consultation concerning nutrition and “Drug Facts” labeling.
Consultation and representation concerning “adverse events,” including injuries or deaths, caused by FDA-regulated products and the reporting requirements relevant thereto.
Consultation with respect to FDA issues attendant to a merger and acquisition, including the transfer of FDA registrations and food facilities and product lines.