Month: May 2019

SELF IDENTIFICATION – AN OVERVIEW

The Generic Drug User Fee Amendments of 2012 (GDUFA) requires that the manufacturers of human generic drugs, active pharmaceutical ingredients manufacturers (API) and the organizations which support the manufacture or approval of generic drugs to identify themselves electronically  and update the  information annually to FDA.

Self-identification is a vital requirement to help global supply chain transparency and provide assistance in building an accurate inventory of facilities and organizations involved in the manufacture of generic drugs and also simplifies inspections and compliance.

Who requires Self-Identification?

  1. Facilities that manufacture human generic drug APIs or Finished dosage form of drugs (FDF) or both.
  2. Packager and labeler of generic drugs.
  3. Facilities identified in generic drug submission where the applicant remove the drug from a primary container and subdivide in to different primary containers.
  4. Labs that are performing Bioequivalence (BE)/bioavailability (BA) tests.
  5. Facilities identified in a generic drug submission where the testing is performed to check the characteristics of the FDF or the API pursuant to a contract with the applicant to satisfy a cGMP testing requirement

Who requires to pay the fees?

  1. Facilities manufacturing, or intending to manufacture, API of human generic drugs and/or finished dosage form (FDF) human generic drugs.
  2. Facilities that engage in generic drug packaging and labeling (FDA consider these as manufacturing facilities)

Who does not require to pay the fees?

  1. Firms that engages in testing, repackaging or relabeling are not required to pay the fees.

Penalty for not submitting Self– Identification

  1. Under GDUFA, all FDF or API products manufactured at the facility will be considered as misbranded. 
  2. Products manufactured in foreign facilities are considered misbranded and it is a violation of federal law to market misbranded products in interstate commerce or to import the products into the United States.

Drug manufacturers’ needs to submit their Self – Identification information to FDA through Electronic Submission Gateway (ESG) by creating Structured Product Labeling (SPL) files.

For FY 2019, the Self-Identification period starts from May 1st 2019 to June 1st 2019.

Liberty Management Group, a leading FDA consulting firm provides assistance with SPL preparation and submission of Self-Identification to FDA.

Sudhs S

Regulatory Consultant

Mail: office@libertymanagement.us

http://www.fdahelp.us

BASICS OF IMPORTATION – MEDICAL DEVICES

FDA regulates a range of products which includes food (human and animal consumption), medical products (drugs, devices and biological products), radiation-emitting electronic products, tobacco products and cosmetics. All imported shipments of FDA regulated products are evaluated by FDA and needs to comply with same regulations as of domestic products.  The products that are offered into U.S including personal items must be declared to U.S. Customs and Border Protection (CBP). CBP will refers all FDA –regulated products to FDA for review. Mostly, importers will hire a custom broker to help them in submitting necessary entry documents and applicable payments to CBP on behalf of the importer.  FDA regulated products are refused to enter in US commerce, if they appear to be adulterated, misbranded, or restricted for Sale.   Refused products needs to be destroyed or exported from U.S within 90 days.

MEDICAL DEVICE IMPORTATION

Foreign medical device manufacturers are required to meet applicable US FDA medical device regulations in order to import devices into the U.S although the product is permitted for marketing in another country.  The following are the requirements which FDA checks at the time of importation

  1. Medical device establishment registration
  2. Device listing
  3. Medical Device Labeling
  4. Premarket Notification(510K) or Premarket approval(PMA) if applicable
  5. GMP Regulations
  6. U.S Agent for foreign manufacturers.

The Initial importer of the device are required to register their establishment with FDA.

As per FDA, an initial importer is any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.  FDA medical device establishment registration and listing can be found at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

Manufacturers, Initial importers and device user facilities are subject to Medical Device Reporting (MDR) regulation, where they have to report device-related adverse events and problems to FDA. Importers are required to maintain a MDR event file for each adverse event and also they have to forward all product complaints (MDR and non MDR events) to the manufacturer.

Medical devices that are imported into the United States must meet Custom Border Protection (CBP) requirements in addition to FDA regulations.

Liberty Management Group, a leading FDA consulting group in the United States provides assistance with medical device establishment registration, device listing, medical device label review and US agent service for foreign medical device establishment firms.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

http://www.fdahelp.us