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What is FDA Compliance?
FDA Stands for Food and Drugs Administration in USA. Obviously, there will be such enforcement agencies in all countries with their respective mandatory requirements to be followed for FDA compliance.
FDA compliance is applicable to both Medical Devices Industry and Food Industry.
Every company needs to obtain approval from the FDA that they are FDA compliant prior to production. This is a mandatory condition by US government.
FDA compliance can be obtained through voluntary declaration of FDA compliance to authorities or by inviting, FDA inspecting agencies to conduct an audit on FDA compliance. The requirements for FDA compliance for medical devices are detailed in 21 CFR 820 and for Food Industry are through 21 CFR 111. Popularly these mandatory requirements are called good manufacturing practices or Current Good Manufacturing Practices
- Any company intending to start production of Medical Devices
- Any organization that deals with potential hazards in Medical devices
- Any organization that wants to eliminate microbial residue on medical devices especially where there is human or animal contact
- Any company in the Medical devices sector where sterilization is crucial
- Any business or company that would like to deliver a Safer Medical devices product to the consumers
- Any organization in the medical devices sector that would like to reduce costs of product recalls
- Any Organization intending to start production related to Food Industry including Food Packaging, Storage and Distribution
- Any organization that deals with potential hazards in foods
- Any organization that wants to increase their food safety
- Any company in the food sector that would like to improve quality
- Any business or company that would like to deliver a safer food product to the consumers and producers
- Any organization in the food sector that would like to reduce costs of product recalls
21 CFR 820 Good Manufacturing practices for Medical devices are stipulated in Docket # AE 2.106/3:21 may be accessed through the link provided here
The requirements in Docket mentioned above are to be followed irrespective of which standard the facility is getting certified to.
The details are as follows: (Source: This information is reproduction of docket available on line)
PART 820—GOOD MANUFACTURING PRACTICE FOR MEDICAL DEVICES: GENERAL
Subpart A—General Provisions
Subpart B—Organization and Personnel
Subpart E—Control of Components
Subpart F—Production and Process Controls
Subpart G—Packaging and Labeling Control
Subpart H—Holding, Distribution, and Installation
Subpart I—Device Evaluation
21 CFR 111 Stipulates all requirements of Good Manufacturing practices for Food Industry in Docket # 1790 (Source: This information is reproduction of docket available on line)
All these conditions are covered in ISO/TS 22002 Technical specifications for food Industry
They are detailed as follows: (Source: https://ecfr.io/Title-21/cfr111_main)
Part A—— General Provisions
Part B—— Personnel
Part C—— Physical Plant and Grounds
Part D——Equipment and Utensils
Part E ——Establishing Production Controls
Part F—— Establishing Process Controls
Part G—– Master Manufacturing Records
Part H—– Batch Production Records
Part I ——Manufacturing Operations
Part J—— Packaging
Part N —–Product Complaints
Part O—– Records and Record Keeping
FDA compliance is required before start of production of medical devices prior to any certification.
There are about 10 Steps for obtaining FDA compliance for Medical devices detailed as follows:
The steps may vary depending on Class of Devices
- Determining UDI. UDI, stands for Unique Device Identification. The law for UDI was passed in October 2007. As Per this law, every medical device needs UDI. Different UDI is required for each size, each color and each variation in the product
- Obtain DUNS number: DUNS stand for Data Universal Numbering System which in other words it is the registration of your company with Federal agencies and is a federal identification number for your facility
- Obtain GMDN: GMDN stands for Global Medical Device Nomenclature. This is to get a name for your product which is universally acceptable for example Implants means an external part or component become a part of your body during its life time. Name should not be misleading is the intention
- Fix the number of UDIs: Plan and Fix the number of UDIs are required for your Product range.
- Get UDIs. Allotted; Obtain all UDIs from FDA approved agencies to avoid problems at a later stage
- Appoint a regulatory contact: One of the responsible employees is to be nominated and designated as a regulatory contact. This is required for registering the firm in a Global Unique Device Identification Data Based (GUDID) Register the firm in GUDID
- Select PI for your products: PI stands for Product identifier. In addition to UDI the product needs a product identifier which could be a lot #, Batch #. Heat # or such similar identifying factors.
- Decide the Mode of submission to GUDID: Once UDIs and PIs are decided and confirmed firm needs to decide on mode of submission to GUDID. The submission can be in paper mode or electronic mode
- Create a GUDID Account: Once registration is complete and labeling details are frozen then with all available data open a GUDID account
- Submit to GUDID: Once all formalities are complete and all documents stated in 21 CFR 820 area ready then log on to GUDID and submit the forms. All forms required to show evidence that all good manufacturing practices are currently being followed and there is data to show as evidence. FDA compliance will be granted by FDA once documents are satisfactory.
FDA Compliance for Food
FDA does have the authority to inspect regulated facilities to verify that they comply with applicable good manufacturing practice regulations.
Owners and operators of domestic or foreign food, drug, and most device facilities must register their facilities with FDA, unless an exemption applies.
In general, FDA regulates:
- Dietary Supplements
- Bottled Water
- Food Additives
- Infant Formulas
- Other Food Products (although the U.S. Department of Agriculture plays a lead role in regulating aspects of some meat, poultry, and egg products)
In fact, FDA regulates all foods. food packaging where there is contact with food, food ingredients introduced into or sold commercially. Exception is for meat, poultry, and certain processed egg products regulated by the U.S. Department of Agriculture (USDA).
Forms required for FDA compliance are available in 21 CFR 111.
All forms are to be completed, evidence of FDA compliance provided and declared voluntarily to FDA authorities to obtain FDA compliance. An FDA compliance certificate will be provided based on evidence submitted or based on inspection report by Food Safety Inspection Services wing of FDA.
- FDA compliance certification is a proof of adherence to FDA regulations
- FDA compliance entails the facility to start production
- Ensure that basic Hygiene and cleaning provision are being met.
- Improve control of product processes
- Improves Food Safety in products
- Improve product quality of medical devices
- Reduce costs associated with product recalls
- Eliminate hazardous risks
- Instills confidence in consumers
- Meet the mandatory federal requirements of FDA compliance
- FDA compliance is a prelude to certification to ISO Standards and other applicable standards
- QSE has been in the business of Food Safety and Medical Devices Consulting over 27 Years now
- All QSE auditors are competent and qualified
- QSE ensures application of all cGMP conditions and templates provided by QSE stand as evidence for FDA compliance
- Additional paperwork will not be needed once QSE gives the documentation
- QSE’s unique systems will help facilities sail through audits for FDA compliance with nil or minimal nonconformities
- QSE assists in implementing ISO/TS 22002 requirements for food industry to covert al requirements stated in GMP
Frequently Asked Questions
No, but QSE will train individuals and provide all templates required as evidence to enable them to obtain FDA compliance certifications from the FDA.
QSE helps the facility prepare for FDA compliance QSE offers consultation for all services from concept to certification. The preparation for implementation of cGMP in the facility will help the facilities pass FDA audits without any nonconformity.
We do understand that some consultants do charge by the hour, but QSE Charges by the day or on consolidated price. QSE does not charge extra when work gets extended beyond normal office hours. QSE does not charge for Phone consultation seeking clarifications or advises in implementation.